Clinical Research Physician Resume Samples

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N Brakus

Nicholaus

Brakus

58166 Torp Lakes

Boston

+1 (555) 460 1216

58166 Torp Lakes

Boston

Phone

p +1 (555) 460 1216

Experience Experience

New York, NY

Clinical Research Physician

New York, NY

Goyette LLC

New York, NY

Clinical Research Physician

Assist Operations and Client Managers with sponsor visits
Provides responsible, competent medical research advice to management
Perform on-study and post-study physical examinations to ensure that the physical and mental wellbeing of volunteers is undiminished at the end of the study
Provides leadership to the clinical study team involved in the execution of clinical studies
Review and evaluate protocols and provide clinical and scientific support
Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following
Participate in the on-call system for providing 24/7 medical support

Dallas, TX

Clinical Research Physician Neuroscience

Dallas, TX

Cronin Group

Dallas, TX

Clinical Research Physician Neuroscience

Perform local AE review and provide general medical support for safety issues
Provide assistance to ICRO and site for IEC/IRB Interactions
Provide medical expertise support to pharmacovigilance activities
When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
Assist in writing country or site specific Informed Consent Forms (ICF)
May be called upon to provide strategic medical input into protocol design at a global level
Lead and/or perform protocol, country and site feasibility

present

Detroit, MI

Medical Director, Clinical Research Physician

Detroit, MI

Lesch, Greenholt and Frami

present

Detroit, MI

Medical Director, Clinical Research Physician

present

Participates in Development Strategy to make recommendations, take action and provide clinical research expertise
Prepare, present and manage materials for external advisory boards to guide protocol and product development
Interact seamlessly with biomarker translational scientists to inform and refine clinical product development and strategy
Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision
Provides high quality, current and timely medical/scientific input into sections of key documents relevant (IB, annual safety reports, etc) to the area of responsibility
Provides medical, clinical and scientific guidance to the study team, affiliate medical personnel and investigative sites
Provide clinical leadership to allow for initiation of trials in EU in collaboration with regulatory and clinical operations team members

Education Education

Bachelor’s Degree in Clinical Medicine

Johnson & Wales University

Bachelor’s Degree in Clinical Medicine

Skills Skills

Knowledgeable in the areas of clinical research and regulatory affairs as they relate to clinical studies and healthcare management
Intermediate knowledge of Microsoft Word 2013, including the ability to troubleshoot issues
Previous research experience – basic and/or translation is desirable
Able to demonstrate strong communication, interpersonal, organizational, and negotiating skills
Excellent teamwork skills
Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Demonstrated strong communication,, interpersonal, teamwork, organizational and negotiation skills
Demonstrated ability to balance scientific priorities with business priorities
Regulatory experience in support of INDs, BLAs, NDAs, supplemental applications etc. is desirable

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12 Clinical Research Physician resume templates

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Clinical Research Physician Resume Examples & Samples

Participate in executing a clinical protocol for a phase III clinical trial comparing two smallpox vaccines, including but not limited to conducting medical histories and physical examinations, assessing clinical laboratory tests, wet reading of EKGs, assessing cardiac risk, calculating renal clearance, calculating BMI, administering vaccine, assessing adverse events and evaluating data related to the immune response and trial outcomes
Prepare or assist in the preparation of reports of research activities and results/outcomes for submission to the Food and Drug Administration (FDA) and assist with preparing manuscripts of research activities and results/outcomes for publication as assigned by Lead Principal Investigator and Site Principal Investigator
Participate in meetings and presentations related to assigned duties and/or work performed
As required, trains and assists coworkers and technical staff in special knowledge and skills
Provide any required written summaries, reports, and other documents as needed in support of the clinical trial
The contractor shall perform duties and responsibilities independently based on broad guidelines and objectives provided by the Lead and Site Principal Investigators and own initiative. Performance is evaluated based on the completeness, accuracy and timeliness of results, conformance to established policies, standards and objectives, and, effectiveness of communications and interpersonal skills
Provide administrative and logistics support of trial as needed

Clinical Research Physician Neuroscience Resume Examples & Samples

Lead and/or perform protocol, country and site feasibility
Provide protocol, Risk management plan & disease training as appropriate at Investigator’s Meetings or scientific venues or internally
Provide medical expertise support to pharmacovigilance activities
Follow-up with the Investigator for additional information or clarifications as needed
When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
Review and try to resolve local medical issues / questions that arise during the entire course of the study
Assist in writing country or site specific Informed Consent Forms (ICF)
May be called upon to provide strategic medical input into protocol design at a global level
Support planning, implementation and follow-up of regulatory agency inspections and internal audits
Ability to assess the feasibility of implementing the protocol based on regional medical practice

Clinical Research Physician Resume Examples & Samples

As Clinical Research Physician/Scientist you are responsible for planning, preparation, conduct and reporting of Phase II - IV clinical trials mainly in the areas of cardio-metabolism and/or CNS within the department of Clinical Research Germany
As local study manager, you are the leader of the local trial team being responsible for the local performance, quality and oversight in multinational clinical trials. This includes selection of investigational sites, development of key documents for the local regulatory submission, and performance of investigational sites regarding quality and recruitment. You are the local point of contact for medical and operational questions of investigational sites and of your trial team. Furthermore you are responsible for the local trial budget
As international study manager, you are the leader of the international trial team being responsible for the global performance, quality and oversight in multinational clinical trials. As author of the Clinical Trial Protocol, you are in close contact to relevant stakeholders in the clinical development and translational medicine organization. You are in contact with external experts and external partners required for conduct of the clinical trial. Organization of trial-specific meetings, e.g. Investigator´s Meeting, Data Monitoring Committees is within your expertise. You are the main contact person for medical and operational questions of the investigational sites and of the trial team. Furthermore you are responsible for the global budget of the trial including external partners
You ensure adherence to local and international, internal and external regulations, quality, compliance and data integrity on local respectively global level of clinical trials
You provide internal medical and operational consultancy, advice and training on various aspects within clinical trials

Clinical Research Physician Resume Examples & Samples

Clinical research or pharmaceutical medicine experience preferred
Knowledge of drug development process preferred
Fluent in English; both written and verbal communications
Interpersonal, organizational and negotiation skills
Excellent teamwork skills

Clinical Research Physician, Immuno Resume Examples & Samples

Assist Lilly scientists with target identification and validation efforts guided toward development of new oncology therapeutics
Provide expertise to drug-discovery teams involved in clinical candidate selection overseeing laboratory to clinic transition of oncology compounds
Develop and implement medical aspects of global strategy and clinical plans for various oncology compounds
Interact with consultants, clinical pharmacologists, clinical investigators, and affiliate CRPs to plan, initiate, and conduct global clinical trials
Develop and/or review clinical trial protocols for clinical trialsand serve as medical lead for trial conduct
Collaborate on the statistical analysis and preparation of clinical study reports
Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and outside audiences, and publish results of research projects
Provide support for global regulatory reports
Monitor safety reports and implement appropriate pharmacovigilance actions, if necessary
Establish and maintain contact with external experts and opinion leaders
Explore and pursue opportunities for extramural scientific relations
Attend and participate in scientific symposia as well as administrative and business workshops
Monitor global scientific/medical literature
Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities
Medical Doctor or Doctor of Osteopathy. Must be board eligible in oncology or hematology and have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Foreign medical graduates who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer
Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Clinical experience in the field of medical oncology and experience with the clinical trial process, particularly with oncology phase I and phase II (proof-of-concept) studies
Clinical and/or scientific experience in cancer immunology
Knowledge of drug development process is preferred
Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Willing to engage in domestic and international travel to the degree appropriate to support the business of the team
A scientific background in immunology with laboratory experience is desirable

Clinical Research Physician, Medical Affairs Resume Examples & Samples

Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign
Excellent English communication (written and verbal), interpersonal, organizational and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Demonstrated leadership and teamwork skills
Clinical and clinical trial expertise in GI cancer
Experience with lecturing, teaching, and/or writing about GI cancer
Translational research experience (e.g. biomarkers), particularly in GI cancer
Knowledge of the drug development process, particularly within the US
Pharmaceutical medicine experience

Clinical Research Physician Resume Examples & Samples

Provides subject matter expertise in medicine for all clinical research studies during the design and implementation phases of study protocols
Conducts physical, oral and other clinical assessments, with prospective and enrolled participants for research purposes only, as required by study protocols
Assists the study RN and study Principal Investigator, as needed, in determining participant eligibility for study enrollment and completion
Conduct follow-up calls/exams with research participants as may be specified by study protocols
In coordination with the study RN, respond to unanticipated and adverse events, and other medical emergencies as may arise
Review and contribute to the development of new or the updating of current clinical laboratory SOPs
Provides responsible, competent medical research advice to management
Treat as highly confidential, all data and information collected as part of day-to-day research operations

Temp / Clinical Research Physician Resume Examples & Samples

To provide medical safety and medical cover when monitoring study participants
To assess and interpret study clinical data, e.g. Pulse, BP, ECG’s, laboratory tests, adverse events etc
To provide medical support for human volunteer studies of new and existing pharmaceuticals
To assist in dosing of study medication
To work in accordance with ICH and GCP

Clinical Research Physician Resume Examples & Samples

Oversee safety issues of projects conducted by ICON which will include, but not be limited to, the following
Adverse event reporting to the sponsor
Follow up of adverse events as necessary
Communication of safety issues to the head of the department or designee
Participate in the on-call system for providing 24/7 medical support
Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following
Medical information source
Ongoing training for project teams in therapeutic areas as requested
Review of study documentation (protocol, CRF. etc.)
Contribute to investigator meeting presentations
Ongoing safety review of individual patient laboratory reports generated by central laboratories
CRF safety review
Contribute any necessary medical input into integrated clinical and statistical reports
Assist in making presentations to potential clients when appropriate
Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs
Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations
Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention
Line management of DSAs as appropriate
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Medical degree (MBBS)
Preferably 2 years experience in a relevant clinical research role
Ability to medically evaluate clinical data
Good oral and written communication skills including proficiency in English
Ability and willingness to travel on an as-need basis
Good computer skills (MS: Outlook, Word, Excel)

Medical Director, Clinical Research Physician Resume Examples & Samples

Drive clinical trial protocol development and execution through regulatory filings
Prepare, present and manage materials for external advisory boards to guide protocol and product development
Provide medical guidance to investigators on managing patients on clinical protocols
Interact seamlessly with biomarker translational scientists to inform and refine clinical product development and strategy
Provide therapy area medical and scientific expertise to study teams and key stakeholders
Build and own investigator relationships across Europe for multiple indications and protocols
Provide clinical leadership to allow for initiation of trials in EU in collaboration with regulatory and clinical operations team members
Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision
Provide input into clinical sections of IND’s, Investigator Brochures, CTA’s , ISS’, ISE’s and clinical expert reports
Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area
Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL’s
LI-SL1
Clinical expertise in the treatment and management of patients with hematologic malignancies and/or patients undergoing allogeneic stem cell transplant
Working knowledge of Good Clinical Practice and clinical research
Excellent written and spoken communication skills
Keen ability to analyze clinical efficacy, safety, and biomarker data
Interest/ability to evaluate early stage assets and participate in Business Development Due Diligence

Clinical Research Physician Resume Examples & Samples

2 years clinical experience and/or two years of experience in clinical research coupled with an understanding of the International Conference on Harmonisation Good Clinical Practice (ICH GCP)
A flexible attitude with respect to work assignments, new learning and travel
Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
Willingness to work with multiple supervisors in a matrix environment, and to value the importance of teamwork
IT literate – Experience with Microsoft based applications and general knowledge of PC functions

Clinical Research Physician Resume Examples & Samples

Responsible for ensuring that the clinical trial is conducted according to the investigational plan and all applicable regulations
Provide medical and scientific feasibility of all new sponsor inquires
Direct test article administration or dispensation
Review and evaluate protocols and provide clinical and scientific support
Liaise with sponsor regarding study design and site capabilities
Interact with regulatory bodies as is relevant to clinical operations
Attend study initiation meetings
Present protocols at IRB/IEC meetings, as required
Assist Operations and Client Managers with sponsor visits
Perform pre-study physical examinations and review lab data to ensure volunteers are medically and mentally fit upon entering the study
Perform on-study and post-study physical examinations to ensure that the physical and mental wellbeing of volunteers is undiminished at the end of the study
Inform Principal Investigator, IRB and Sponsor as appropriate of relevant events
Review and sign CRFs at the conclusion of the study
Act as Principal Investigator/Co-Investigator as assigned by the Medical Director
3-5 years MD experience

Clinical Research Physician Resume Examples & Samples

Previous clinical experience in direct patient care
Previous experience of performing a clinical research role within a clinical research organization or pharmaceutical company
Excellent written & verbal communication skills required including a good overall scientific vocabulary
Intermediate knowledge of Microsoft Word 2013, including the ability to troubleshoot issues

Medical Director, Clinical Research Physician Resume Examples & Samples

Provides Therapeutic Area expertise to study teams and key stakeholders
Participates in Development Strategy to make recommendations, take action and provide clinical research expertise
Ensures optimal study conduct; leads the clinical study, in liaison with the Clinical Trial Manager, from study set-up through study conduct until study closure and study report
Medical monitoring of clinical studies. Ability to review patient eligibility criteria, make medical decisions and regularly review/ monitor any possible safety issues
Provides medical, clinical and scientific guidance to the study team, affiliate medical personnel and investigative sites
Nurtures professional relationships with Investigators, Academic partners and KOLs
Maintains scientific expertise in Therapeutic Area concordant with current knowledge and practice
Provides high quality, current and timely medical/scientific input into sections of key documents relevant (IB, annual safety reports, etc) to the area of responsibility
Contributes to the planning and review of abstracts, manuscripts and presentations for external meetings
Presents at Internal and External Meetings, representing the team with internal and external leaders
Participates in activities of the multifunctional Disease Area team
Consolidated experience in the therapeutic area, including patient clinical experience
Experience in the design and execution of hematology protocols
Excellent written and verbal communication skills and interpersonal skills. Ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion
Competencies related to the Clinical Development Process (Planning , coordinating and organizing, decision making, delivery of results, personal accountability, technical and professional knowledge, facilitating change)
Ability to understand and present data at internal and external meetings, including Investigators’ meetings and Data Review Meetings
Knowledge of the clinical development process and strong relationships with team members, colleagues and internal and external stakeholders to achieve results

Clinical Research Physician Resume Examples & Samples

Minimum master degree in clinical medicine or related bioscience
Knowledge of clinical development process, and regulatory requirements
Knowledge in industry setting
Interpersonal communication skill
Excellent written/verbal communication skills in English Team player
Project Management skill
Knowledge of PC (WORD, EXCEL, POWERPOINT)
Presentation skill

Clinical Research Physician Resume Examples & Samples

Medical Doctor or Doctor of Osteopathy
Preference will be given to candidates with internal medicine or endocrinology training
Must be Board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Knowledge of drug development process relevant to country/region preferred
Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
Medical affairs experience
Demonstrated strong communication,, interpersonal, teamwork, organizational and negotiation skills
Not a requirement but highly desirable---Knowledge in immunology and/or cardiovascular medicine

Clinical Research Physician Resume Examples & Samples

Provides leadership to the clinical study team involved in the execution of clinical studies
Oversees and is responsible for the quality, coordination and timeliness of protocol development
Oversees and is responsible for the quality, coordination, medical accuracy and timeliness of clinical study reports
Assists senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS's, ISE's, and clinical expert reports
Participates, as required, as a clinical representative on Project Teams
Establishes and maintains working relationship with Study investigators, key opinion leaders, academicians, and Senior managers and department heads across the corporation
Ensures adherence to GCP/ICH and SOP standards
Maintains clinical and scientific awareness in area of expertise. Supports clinical operations in site selection, study budget preparation, study execution and addresses clinical/medical issues at study sites
Participates in the organization, coordination and execution, as required, of internal meetings and external medical/scientific meetings, e.g., Investigator Meetings and clinical/scientific advisory board meetings
Develops and gives oral presentations, as required
Supports data management as required for CRF development, database edit checks development, listings review, query resolution, database clean-up and lock activities
Prepares clinical study timelines and status reports, as required, per Supervisor

Clinical Research Physician Resume Examples & Samples

MD plus completion of Fellowship program
Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer. Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
Must be able to demonstrate basic knowledge of the drug development process and exercise Good Clinical Practice (ICH GCP) principles
Must be fluent in English; both written and verbal communications
Able to demonstrate strong communication, interpersonal, organizational, and negotiating skills
Able to engage in domestic and international travel to the degree appropriate to support project and business needs
Previous research experience – basic and/or translation is desirable
Demonstrated experience and involvement in clinical trial design or execution
Regulatory experience in support of INDs, BLAs, NDAs, supplemental applications etc. is desirable

Senior Clinical Research Physician Resume Examples & Samples

Leading the clinical team activities providing expertise and significant contributions to Clinical Project Teams, Study Teams, Global Development Teams and Global Brand Teams
Preparing clinical development plans and institute properly approved clinical protocols. Presenting and defend protocols. Implement clinical R&D policies, SOPs and related directives
Monitoring study progress, leading the analyses and data evaluation process for progress reporting and presentations to senior management
Preparing various official and regulatory documents for Regulatory and other agencies, such as Dossiers, NDAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex safety or efficacy issues
Serving as the Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I-II studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation
Ensuring that Serious Adverse Events are properly reported on a global basis
Leading cross-functional teams comprised of multidisciplinary professionals and clinical scientists. Directing responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets
Reviewing potential in-licensing candidates and present recommendations to Senior Management groups
Supporting any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities
Contributing and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio
M.D. degree or equivalent, board certified (or eligible). Medical specialty and sub-specialty training and certification are required in Diabetes / Endocrinology
Diabetes / Obesity / NASH therapy experience
Significant experience in clinical research and/or endocrine drug development in pharmaceutical or CRO environment
Excellent oral and written communication skills; strong interpersonal and listening skills
Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
Ability to make sound and timely decisions; agile in learning and action oriented
High level of emotional intelligence; able to deal with ambiguity
Able to relate to varied level audiences across organisation; able to build and lead effective teams and coach & develop team members; able to set priorities for team and maintain accountability; skilful in negotiating organisational boundaries and hierarchy; experience managing and developing others
Clinical or research experience in field of specialisation
A fellowship or training and certification in Endocrinology

Clinical Research Physician, Diabetes Resume Examples & Samples

Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list
Three to 5 years of clinical care and clinical research or pharmaceutical medicine experience
Pediatric Endocrinology experience preferred including diabetes and growth hormone deficiency treatment
Demonstrated ability to balance scientific priorities with business priorities
Fluent in English, verbal and written communication

Clinical Research Physician Resume Examples & Samples

Responsible for protecting the rights, safety and welfare of participants under their care
Administers test article to the subjects, or delegates this to nursing staff where appropriate
Perform pre-study physical examinations and review lab data and all inclusion/exclusion criteria to ensure volunteers are medically and mentally fit upon entering the study
Perform on-study and post-study physical examinations to ensure that the physical and mental well being of volunteers is undiminished at the end of the study
Inform Principal Investigator, IRB/IEC and Sponsor as appropriate of relevant events
Delegate the above as appropriate
Typically 2 years MD experience
Needs to have at least 2 years experience in clinical training posts
Previous CRO or Phase I experience preferred but not required