Clinical Research Scientist Job Description
Clinical research scientist
provides clinical support for project according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
Clinical Research Scientist Duties & Responsibilities
To write an effective clinical research scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Protocol development and implementation data collection, analysis, review, reporting and publishing in compliance with the company's processes, adherence to quality standards and GCP/ICH and regulatory guidance
The successful candidate will join a multi-disciplinary research team focused on supporting the development of new therapeutics for hepatitis B virus (HBV)
Major responsibilities include participation in cross-functional teams managing external collaborations in support of HBV development programs
In addition, he/she will be the virology representative for ongoing HBV clinical trials
Provide support for the development of HBV assays/ technologies as needed
Developing the scientific and operational plans for trial level clinical deliverables
Supporting the development of the Operational CDP (O-CDP)
Creating trial concept sheet(s), executable synopses and contribute to final protocol
Developing strong scientific partnership with key investigators in assigned therapy area(s) to optimize scientific quality/innovation of program and/or clinical study design, execution, reporting and publication
Assisting Medical Lead with set-up of program and/or trial-related advisory groups
Clinical Research Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Research Scientist
List any licenses or certifications required by the position: ASCP, CLS, MT
Education for Clinical Research Scientist
Typically a job would require a certain level of education.
Employers hiring for the clinical research scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Life Sciences, Medical, Nursing, Science, Pharmacy, Medicine, Sciences, Biological Science, Health/Medical, Graduate
Skills for Clinical Research Scientist
Desired skills for clinical research scientist include:
Disease area
Dose review teams
Independent response adjudication committees
Establishment and operation of data monitoring committees
Clinical trial design
GCP and ICH Guidelines
Basic statistics
Statistics
Clinical operations
GCP/ICH
Desired experience for clinical research scientist includes:
Collaborating with Medical Lead in the development of program level documents, including clinical sections of regulatory documents
Develop new methodologies and framework to maximize the adoption and usability experience of product concepts
Build relationships with Key Opinion Leaders (KOLs) stakeholders in user environment such as physicians, nurses, and technicians to identify clinical needs and requirements during product and clinical development
Create documentation for patent applications
Design new protocol and clinical studies for human clinical trials
Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners
Clinical Research Scientist Examples
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Clinical Research Scientist Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical research scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research scientist
- Maintains close working contact with MRL Discovery scientists and assists with selection of promising drug targets and candidates
- Developing a comprehensive clinical plan
- Negotiating with FDA
- Designing and writing clinical protocols
- Designing CRFs and eCRFs
- Identifying and contacting potential investigators
- CRO management
- Negotiating study budgets and financial payments
- Ensuring adequacy of clinical research staff/facilities
- Monitoring clinical studies consistent with GCP
Qualifications for clinical research scientist
- Bachelor’s degree in life sciences with minimum 5 years’ experience in clinical research with a biopharmaceutical/biotechnology company, advanced degree preferred
- Experience with oncology, clinical trials (including biostatistics and clinical databases), IHC and/or FISH, are greatly preferred
- Must be able to work effectively on multiple oncology programs in a fast dynamic environment
- You are characterized by your good scientific, medical and analytical thinking
- Academic training in immunology a strong asset
- Immunology experience strongly preferred
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Clinical Research Scientist Job Description
Job Description Example
Our innovative and growing company is looking for a clinical research scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research scientist
- Writing summary reports
- Preparing technical articles for publication in professional journals and company literature
- Manage the design and execution of clinical trials related to digital pathology, virtual dermatology, and diagnostic/treatment devices within the scope of L’Oreal R&I
- Provides clinical trial and non-clinical trial strategic direction within Neuromodulation scientific, therapeutic areas inclusive of competitive landscape and medical device expertise
- Support Product Development Teams in the evaluation of Product Risk and Design Control Process
- Author manuscripts and abstracts for submission and publication in peer reviewed scientific journals
- Develop a strong understanding of the Operating Company product portfolio and pipeline
- Support publication strategy execution including collaboration with investigators and internal stakeholders
- Determine fair market value (FMV) and plan for study budgets under direction of senior clinical leaders
- Provide leadership to Clinical Study Core Teams
Qualifications for clinical research scientist
- Previous experience managing clinical trials is a plus
- Experience and knowledge of epidemiologic and clinical study design alternatives
- Experience and knowledge of statistical methodologies and interpretation of results
- Masters or Ph.D degree in Biological Sciences, Chemistry, Pharmacology, Cosmetic Science or related field with 1-5 years of post-doc work experience
- Graduate in Life Sciences (Master of Science or equivalent)
- Good medical knowledge and experience in clinical development in all phases with emphasis on Phase II and III clinical studies in Immunology
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Clinical Research Scientist Job Description
Job Description Example
Our growing company is looking for a clinical research scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research scientist
- Be responsible for assigned global post-market investigator-initiated (IIS) or company sponsored Clinical Research Portfolio management within designated Operating Company, , fostering strong, productive relationships with colleagues within the organization
- He/she will be responsible for the management of non-regulated studies and low complexity regulated studies, and may lead project teams
- Manage global post-market non-regulated studies (IIS, Registries, real-world evidence retrospective research, or company sponsored Post-market studies) and provides input and completes clinical tasks with minimal supervision
- Be responsible for front end activities related to clinical feasibility, site identification and selection, and literature reviews with minimal direction
- Summarize key product evidence from published literature and provide updates to internal stakeholders on a regular basis
- Participate in formulating evidence generation strategies with input from various functions including Medical Affairs, health economics and outcome research, and global strategic marketing
- Verify milestones and track payments and budgets for assigned Operating Company-managed projects or IIS
- Develop strong collaborative relationships with Study personnel/investigators and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders
- Support the Clinical Research team in publication planning and development and manages IIS publications tracking
- Possess advanced understanding and maintain current knowledge of regulatory requirements and industry standards on clinical research and publication development
Qualifications for clinical research scientist
- Familiar with creation of slide presentations
- Ability to work in a Matrix Organization environment
- Doctoral (Pharm.D, PhD, or MD) degree preferred
- Minimum of 3-7+ years of experience in clinical research in the pharmaceutical industry
- Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
- A recognized expert in the development of oncologic therapies, with outstanding scientific and leadership ability
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Clinical Research Scientist Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical research scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research scientist
- Provide leadership on assigned clinical projects
- Provide clinical/scientific input during the development and execution clinical trials
- Review scientific literature Initiate database analyses to support commercial/clinical objectives Contribute to the preparation of clinical study reports and regulatory submissions
- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL Identify new clinical research opportunities
- Prepare or assist with preparation of key documents Investigator Brochures, FDA Briefing Documents, internal or external presentations
- Develop evidenced based operational feasibility reports in support of clinical trial and program teams to execute clinical studies according to business objectives
- Serve as a consultant to project and program teams for new and existing product development teams planning programs and studies
- Independently manage the scope of work, objectives, quality of deliverables, and other activities of assigned projects
- Identify informational/evidenced based needs of project teams and collaborate with cross functional stakeholders to acquire data assets to address relevant execution challenges
- Identify risks to execution and initiate collaborative efforts with cross functional stakeholders to identify solutions and assess their potential impact to trial planning and execution
Qualifications for clinical research scientist
- Experience authoring regulatory documents for cancer therapies is required
- Demonstration of a record of scientific scholarship and achievement
- Experience with ELISA and Immunoassay development
- Experience or knowledge of ECL, MSD, Gyros
- Previous experience with Oncology Clinical Research studies is required
- Highly motivated scientist with PhD in a life science discipline or MD/Pharm D degree, with 3-5 years clinical experience in a pharmaceutical, personal care, or contract research industry
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Clinical Research Scientist Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical research scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research scientist
- Coordinate feasibility activities and team communications to ensure that overall project milestones are met
- Maintain knowledge of current and innovative methods to assess clinical program/trial feasibility, potential vendors, trends, and technologies to increase efficiency, accuracy,productivity and recommend strategic support as needed
- Leverage internal and external intelligence to support and refine methods and tactics on assigned projects
- Support continued process improvement to ensure quality within the organization
- May mentor peers and cross functional colleagues
- Design and develop study protocols and informed consents
- Provide scientific input, review, and edits to clinical study reports, Investigator Brochures, narratives, INDs, NDAs, briefing documents, annual reports, and other regulatory submissions
- Assist with budget projections for clinical activities (such as consultants, advisory board meetings, ) for assigned clinical programs
- Prepare DMC and/or adjudication charters
- Contribute to the development and deliver appropriate Global evidence generation and dissemination strategies (EGS/EDS) to support new product development and lifecycle management within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access)
Qualifications for clinical research scientist
- PhD/MS/BS degree in a relevant scientific area
- Experience in clinical research and/or risk surveillance and management and/or clinical evaluation reports and/or regulatory affairs (medical devices or equivalent in pharmaceuticals) – must have experience in minimum 2 of these fields
- Good literature evaluation skills, ability to critically evaluate medical data
- Assay design experience
- Minimal 5 years pharmaceutical/biotech industry or related experience
- Biomedical Science degree • Excellent knowledge of the clinical trials in both academia and industry