Senior Clinical Research Resume Samples

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S Metz

Selena

Metz

933 Micaela Route

Dallas

+1 (555) 873 7627

933 Micaela Route

Dallas

Phone

p +1 (555) 873 7627

Experience Experience

Detroit, MI

Senior Clinical Research Professional

Detroit, MI

Roberts, O'Kon and Gibson

Detroit, MI

Senior Clinical Research Professional

· Provide psychosocial assessments of patients and families to identify emotional, social, and environmental strengths and problems related to their diagnosis, illness, treatment, and/or life situation
· Provide education and counseling to patients and families around issues related to adaptation to the patient's illness and/or life situation; may utilize crisis intervention, brief and long-term individual, group, and family therapies
· Provide therapy through face-to-face sessions, or telephone conferencing
· Liaison with community agencies; participate in area activities related to mental health
· Ensure that patient care documentation is timely, legible, and efficient. Documentation should be concise, pertinent, and meet the profession's and department's documentation standards. Oral reporting should be clear, concise, relevant, and timely
· Participate in staff meetings, quality improvement efforts, and make sure peer review standards are met
· Keep current with social work and health care developments and seek to increase further enhancement of job related knowledge

Chicago, IL

Senior Clinical Research Coordinator Licensed

Chicago, IL

Haley LLC

Chicago, IL

Senior Clinical Research Coordinator Licensed

Participate in conferences, meetings and seminars concerning research and surveillance projects to enhance knowledge base
Develop policies and procedures within area of responsibility
Assist with study start up and study closure activities such as site initiations and study close out conference calls and or site visits
May assist in the development of protocol defined data collection case report forms
Creates written reports of all monitoring activities to document on site visits including data integrity, newly discovered adverse events and follow action items through to resolution
Report directly to the Clinical Research Director with whom he/she will collaborate on the responsibilities for verification of data collection on grant-funded cardiovascular and neurovascular clinical trials
Participate in regular teleconferences and staff meetings

present

Chicago, IL

Senior Clinical Research Monitor Report Reviewer

Chicago, IL

Kovacek Group

present

Chicago, IL

Senior Clinical Research Monitor Report Reviewer

present

Compile information and provides status updates to monitoring management and to monitoring staff, as requested
Share review knowledge to monitoring management and monitors to initiate and/or support quality improvement efforts
Evaluate quality level of reports and letters in accordance with developed guidance
Provide technical support on systems to monitoring staff
May be involved in the start-up of new studies by providing input on the visit report template
Upon request create and deliver presentations on monitoring review activities
Provide training to monitors on monitoring visit report review processes and visit report completion issues, if requested

Education Education

Bachelor’s Degree in Relevant Technical

University of Tennessee

Bachelor’s Degree in Relevant Technical

Skills Skills

Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, RTG Implantable Therapies and technologies
Demonstrated ability to incorporate and adhere to Good Clinical Practices and regulatory standards
Proficient knowledge in word processing, spreadsheets, and/or database applications (e.g., MS Word and Excel)
Demonstrated ability to identify and adapt to shifting priorities and competing demands
Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing
Demonstrated ability to identify and implement solutions in addressing study issues
Demonstrated ability to maintain composure in difficult circumstances
Demonstrated ability to identify and overcome obstacles
Ability to constructively respond to feedback from customers and coworkers

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15 Senior Clinical Research resume templates

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Senior Clinical Research Mgr Resume Examples & Samples

7 plus years experience managing multiple clinical research studies. Masters degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience
Experience managing medical device and/or pharmaceutical trials
2 plus years clinical study personnel management (i.e., direct people management)
Experience with Good Clinical Practice (GCP) and regulatory compliance guidelines and regulations for clinical trials
Advanced degree (Masters, PhD or MD) preferred
Able to manage multiple tasks

Senior Clinical Research Monitor Report Reviewer Resume Examples & Samples

Perform review of reports in accordance to report review team guidance and expectations, along with monitoring plan requirements
Track processing time throughout review cycle
Evaluate quality level of reports and letters in accordance with developed guidance
Compile information and provides status updates to monitoring management and to monitoring staff, as requested
Partner in close collaboration with Lead Monitors
May be involved in the start-up of new studies by providing input on the visit report template
Upon request create and deliver presentations on monitoring review activities
Share review knowledge to monitoring management and monitors to initiate and/or support quality improvement efforts
Perform critical review of assigned Monitoring Action Item codes
Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
Understand the study protocol and accompanying study specific plans
Contribute to ongoing departmental, cross-functional and project-specific process improvement efforts
May create effective and efficient processes and systems for the review of monitoring visit reports
May work with study teams to prepare for internal or regulatory inspections
Provide technical support on systems to monitoring staff
Provide training to monitors on monitoring visit report review processes and visit report completion issues, if requested
Mentor, train and act as a resource to peers and/or junior personnel
Bachelor’s Degree with 4+ years of clinical research experience required
Bachelor’s Degree in life sciences, health related disciplines or Nursing preferred
Experience in CTMS and Oracle Clinical preferred
National or international certification (SoCRA, ACRP, etc.)

Senior Clinical Research Spec Resume Examples & Samples

Minimum 3 years experience directly supporting clinical research or research experience in medical/scientific area
Ability to independently oversee a study team and trial with little supervision
Understands databases, data analysis, and data presentation
Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, aortic and/or peripheral vascular therapies and technologies
Good understanding of biostatistics and trial design
Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
Presents professional manner and appearance
Computer skills (MS Office products, word processing, spreadsheets, etc

Senior Clinical Research Spec Resume Examples & Samples

Minimum 4 years experience directly supporting clinical research or relevant experience in medical/scientific area
Experience with study management
Strong written, oral, and interpersonal communication skills

Associate Senior., Clinical Research Resume Examples & Samples

Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects
A Bachelor degree from an accredited university or college
An excellent understanding of all aspects of clinical research

Senior Clinical Research Spec Resume Examples & Samples

2 years’ Project Management experience in a clinical setting
Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation and reporting
Preferred education in engineering, life sciences or related medical/scientific field. Advanced degree preferred (Masters, MD, or Ph.D), RN preferred
Experience with Medical Device Industry Clinical Research
Work Experience directly supporting clinical research or similar experience in a medical/scientific area
Exposure to Clinical Operations
Demonstrated ability to work effectively on cross-functional teams. (Including R&D, Marketing, Operations)
Proficiency with writing reports, business correspondence and procedure manuals
Finance and budgeting knowledge
Knowledge of Diabetes
Advanced written and oral communications skills, with proficient knowledge of medical terminology
Ability to present complex technical products and processes to physicians in a clear, direct manner
High attention to detail and accuracy and ability to manage multiple tasks
Strong prioritization, organizational, and problem solving skills
Ability to work independently, with positive flexible outlook
Ability to present a professional manner and appearance
Experience with GCPs and regulatory compliance guidelines for clinical trials

Senior Clinical Research Mgr SH Resume Examples & Samples

Bachelor’s Degree in relevant biomedical field (Medicine, Biomedical Engineering, Medical Physics, Medical Biology, Health Sciences, etc)
Ph.D. or MD (will substitute for 2 years of experience)
Master’s Degree in relevant Biomedical field
Master of Business Administration
10+ years experience directly supporting clinical research or similar experience in a medical/scientific area
5+ years experience managing people, budgets and clinical studies across cultures and countries in Asia Pacific region
3 – 5 years as a clinical research specialist
3 – 5 years of medical device or pharma industrial experience

Senior Clinical Research Spec-erp Resume Examples & Samples

Bachelors degree and 4+ years clinical research experience to include study processes and study design; 2+ Years with Masters, or 0 with Doctorate
Experience as a clinical research specialist or customer specialist
Demonstrated ability to incorporate and adhere to Good Clinical Practices and regulatory standards
Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, RTG Implantable Therapies and technologies
Project management capability
Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical studies
Demonstrated ability to identify and implement solutions in addressing study issues
Ability to identify customer requirements and manage expectations for clinical studies
Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing
Demonstrated ability to maintain composure in difficult circumstances
Demonstrated ability to identify and overcome obstacles
Ability to constructively respond to feedback from customers and coworkers
Proficient knowledge in word processing, spreadsheets, and/or database applications (e.g., MS Word and Excel)

Senior Clinical Research Data Specialist Resume Examples & Samples

Independently create CRFs (Case Report Forms) in electronic database systems to collect data from all clinical trials. The SCRDS ensures data collection is accurate, capturing all activities required by the protocol including, but not limited to all data groups such as: enrollment information, clinical labs/procedures, demographics, infusion information, response data, etc. The incumbent must be able to understand the needs of complex, high-risk, gene and immunotherapy clinical research protocols, and accurately build case report forms that capture required research information to ensure primary and secondary endpoints are captured
Continually evaluate the CRFs for required modification due to the dynamic nature of this research. Amend CRFs due to protocol amendments/changes in study endpoints
Oversee the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures
Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements
Provide input into study and project level data analysis plans
Participate in the preparation and presentation of study data/reports
Facilitate data cleaning activities including data review and query generation
Produce and provide metrics on data entry/processing to the Project Manager
Solve operational problems and be responsible for implementing process and system improvements
Coordinate the archiving of study data and study related documents
Interact with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured

Senior Clinical Research Budgeting Specialist Resume Examples & Samples

Experience in cost planning and Common Procedural Terminology (CPT) coding
Direct experience with budget negotiations experience a plus
Knowledge of federal regulations related to clinical research and billing compliance
Experience in healthcare compliance, general healthcare billing compliance, research billing, or research billing compliance
Knowledge of healthcare billing and claims processing a plus
Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations
Experience working in an administrative/ business office of a university, hospital, or research institute

Senior Clinical Research Operations Specialist Resume Examples & Samples

Project management experience and/or day to day experience running clinical trials
Involvement in the development and/ or implementation of clinical research education and training
Implementation, workflow development and/or training with respect to an institution or company wide IT support systems (EPIC, document management systems, clinical trial management, electronic data capture systems, etc)

Senior Clinical Research Spec Resume Examples & Samples

4+ years experience in clinical research (GCPs and regulatory compliance guidelines for clinical trials)
Bachelor’s degree in life sciences, engineering, or related medical/scientific field
Ability to manage multiple clinical research sites with proven results in study execution
Previous monitoring experience
Ability to shift priorities and work plan based on department needs
Excellent written and verbal communication skill
Capable of working on multiple projects in a deadline driven environment - demonstrated skill under pressure
Work effectively in cross-functional teams

Senior Clinical Research Operations Manager Resume Examples & Samples

Experience in project/program management in a clinical research environment
5+ years progressive leadership experience
MBA or Masters Degree
Project Management Certification
Strong presentation skills, both delivery and development
Familiarity and experience with communications assessment techniques and tools
Previous experience working cross functionally in a matrixed organization
Experience implementing initiatives through effective influence management skills with those that have no direct reporting

Senior Clinical Research Coordinator Neurology Days Msh Resume Examples & Samples

Analyzes highly complex data gathered on clinical research studies
Coordinates protocols and human subject approvals between various sites
Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials

Senior Clinical Research Coordinator Pulmonary Critical Care Resume Examples & Samples

Must be proficient with Windows-style applications and keyboard, and various software packages specific to role
Proficient with Microsoft Office Suite
Ability to effectively work indepdently
Ability and willingness to learn and apply new techniques
Reliable transportation to travel across the system

Senior Clinical Research Coordinator Pain Management Resume Examples & Samples

Nine years relevant research experience; or six years of research experience in a clinical setting with a Bachelor of Science degree
Current Basic Life Support (BLS) certification from teh American Heart Association
Must have computer skills and dexterity required for data entry and retrieval of required job information
Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the required job processes
Working knowledge and experience in clinical research
Ability to work flexible hours, when applicable

Senior Clinical Research Coordinator Licensed Resume Examples & Samples

Report directly to the Clinical Research Director with whom he/she will collaborate on the responsibilities for verification of data collection on grant-funded cardiovascular and neurovascular clinical trials
Responsible for independently scheduling site monitoring (Review source documentation, case report forms, electronic date entered and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the protocols, investigational plans, monitoring plans, applicable regulatory, IRB standards, guidelines and policies. While onsite, will review all trial device and/or product accountability as necessary
Creates written reports of all monitoring activities to document on site visits including data integrity, newly discovered adverse events and follow action items through to resolution
Assist with study start up and study closure activities such as site initiations and study close out conference calls and or site visits
Assist with compilation of adverse events, source documentation and preparation for Event Adjudication Committee meetings as needed
May assist with data management activities for clinical studies, as required
May assist in the development of protocol defined data collection case report forms
Develop policies and procedures within area of responsibility
Participate in conferences, meetings and seminars concerning research and surveillance projects to enhance knowledge base
Participate in regular teleconferences and staff meetings
Timely responses to site questions are imperative, therefore personal digital assistant (e.g., Blackberry) will be provided
Mentors, trains and reviews the work of less experienced clinical research monitoring staff
Perform other related duties

Senior Clinical Research Assoicate Resume Examples & Samples

Must possess 4+ years of oncology experience
A minimum of four (4) years of monitoring/site management experience is required
Must be able to travel domestically and internationally approximately 65%-85%

Senior Clinical Research Professional Resume Examples & Samples

· Provide psychosocial assessments of patients and families to identify emotional, social, and environmental strengths and problems related to their diagnosis, illness, treatment, and/or life situation
· Provide education and counseling to patients and families around issues related to adaptation to the patient's illness and/or life situation; may utilize crisis intervention, brief and long-term individual, group, and family therapies
· Provide therapy through face-to-face sessions, or telephone conferencing
· Collaborate with care coordinators, social workers, psychologists, physicians and other appropriate treatment team members in diagnostic formulation, treatment direction, and recommendations
· Maintain knowledge of external resources for patient needs to foster recovery
· Liaison with community agencies; participate in area activities related to mental health
· Manage department appointment schedules as appropriate
· Ensure that patient care documentation is timely, legible, and efficient. Documentation should be concise, pertinent, and meet the profession's and department's documentation standards. Oral reporting should be clear, concise, relevant, and timely
· Perform all required data collection for the department and grant requirements accurately and within expected time frame
· Participate in clinical supervision as needed on a scheduled basis
· Maintain current licensure, participate in continuing education, and meet competency skills for evaluations in area of practice
· Maintain knowledge of and compliance with HIPAA policies, documentation guidelines, and other related regulatory requirements
· Participate in staff meetings, quality improvement efforts, and make sure peer review standards are met
· Keep current with social work and health care developments and seek to increase further enhancement of job related knowledge
· Provide education to other health care professionals as needed
· Perform other duties as assigned
Licensed Independent Social Worker with current credentials to practice in the state of Ohio
Master’s degree or doctorate in social work
Minimum 2 years previous supervised social work experience preferred
Proficiency in various computer and software applications preferred
Previous experience in Continuous Quality Improvement activities preferred
HIV experience strongly preferred but not required

Senior Clinical Research Analyst Resume Examples & Samples

Serve as an analytic resource within multi disciplinary project teams
Conduct ad hoc analyses of data as requested by hospitals, clinicians, and internal customers
May work focus on more complex project
Ability to work proficiently with Microsoft Word, Excel, Access, DB2, and SQL
Ability to demonstrate strong time management and project management skills
Strong with customer-service orientation
Ability to be careful and thorough about detail
Ability to perform well in team environment, with employees at all levels, to achieve business goals