Key Responsibilities and Required Skills for Clinical Research Fellow

🎯 Role Definition

The Clinical Research Fellow is a clinician-scientist or medically trained researcher responsible for designing, delivering and overseeing clinical research studies and trials. This role combines direct patient-facing activity (screening, consent, clinical assessment) with study management, regulatory compliance, safety reporting and academic outputs (protocol authorship, presentations and manuscripts). The Fellow works closely with principal investigators, multidisciplinary clinical teams, Research Nurses, study coordinators and sponsor/monitoring teams to ensure trials run safely, efficiently and to high scientific and ethical standards. Core responsibilities emphasize Good Clinical Practice (GCP), institutional review board (IRB)/ethics submissions, data integrity, adverse event management, and contribution to translational research objectives.

Key search terms: Clinical Research Fellow, clinical trials, Good Clinical Practice (GCP), IRB/REC submissions, adverse event reporting, protocol development, patient recruitment, EDC (REDCap/Medidata), trial coordination.

📈 Career Progression

Typical Career Path

Entry Point From:

Junior Doctor / Foundation Year Doctor seeking research time (e.g., FY2, CT1-2)
Clinical Research Associate / Research Nurse promoted to clinician-led research
PhD or MD candidate transitioning to clinical/academic fellowship

Advancement To:

Senior Clinical Research Fellow / Clinical Lecturer
Consultant with an academic portfolio (Clinical Academic Consultant)
Principal Investigator (PI) for investigator-led studies
Clinical Trials Manager / Head of Clinical Research

Lateral Moves:

Clinical Trial Manager or Research Governance Manager
Medical Affairs or Clinical Development in industry
Regulatory Affairs specialist in pharmaceuticals/biotech

Core Responsibilities

Primary Functions

Lead the design, development and writing of clinical study protocols, investigator brochures and informed consent documents, ensuring alignment with scientific objectives, feasibility and regulatory expectations.
Act as a study clinician for patient-facing activities: screen potential participants, assess eligibility against protocol criteria, obtain informed consent, perform baseline and follow‑up clinical assessments and document clinical findings in source records.
Oversee the day-to-day conduct of investigator-initiated and sponsor-led clinical trials, coordinating multidisciplinary teams including research nurses, clinical physiologists, allied health professionals and laboratory staff.
Ensure full compliance with international and local regulatory frameworks (ICH-GCP, FDA, EMA, MHRA where applicable), institutional policies, and ethics committee (IRB/REC) approvals for all study activities.
Prepare and submit ethics (IRB/REC) and regulatory submissions, amendments, renewals and safety reports, and respond to queries from ethics committees, sponsors and regulatory authorities in a timely manner.
Maintain participant safety by performing ongoing safety monitoring, reporting serious adverse events (SAEs) and adverse events (AEs) according to protocol, sponsor and regulatory timelines, and liaising with pharmacovigilance teams.
Implement and maintain accurate, contemporaneous source documentation and study case report forms (CRFs), ensuring data completeness, accuracy and traceability to source documents during source data verification (SDV) and monitoring visits.
Manage investigational medicinal product (IMP) or device handling at the site: accountability, storage, dispensing, reconciliation, temperature monitoring and documentation in line with sponsor and regulatory requirements.
Coordinate site initiation visits, monitoring visits and close-out visits with sponsors/contract research organizations (CROs), prepare required documentation, and address monitoring findings and action plans.
Lead recruitment strategy execution and optimization: develop recruitment pathways, screen referrals, liaise with clinical teams and primary care where necessary to meet enrolment targets while maintaining ethical recruitment standards.
Perform and document protocol-directed procedures (e.g., blood sampling, ECGs, imaging liaison) and ensure appropriate processing, labeling and shipment of biological samples to central laboratories or biobanks.
Contribute to development and review of study-specific data management plans, data collection instruments and electronic data capture (EDC) setup (e.g., REDCap, Medidata Rave, OpenClinica), ensuring data security and confidentiality.
Draft and contribute to statistical analysis plans, work with statisticians on interim and final analyses, and interpret results for safety and efficacy endpoints to inform DSMB/IDMC reviews.
Prepare progress reports, regulatory safety reports, annual reports and close-out documentation for sponsors, funders and oversight committees; present findings at investigator meetings and oversight boards.
Mentor and supervise junior researchers, research assistants and trainees, providing training on protocol procedures, GCP principles, data recording and study SOPs to ensure consistent conduct across the research team.
Manage study budgets, resource planning and cost center tracking for assigned studies; liaise with research finance and contracts teams for grant management and sponsor agreements.
Drive quality improvement and audit readiness by implementing study-specific standard operating procedures (SOPs), participating in internal and external audits, and addressing corrective and preventive actions (CAPAs).
Engage in investigator-initiated research activities: generate hypotheses, develop grant applications, contribute to ethical and funding submissions, and take a leading role in writing manuscripts for peer-reviewed journals.
Facilitate multidisciplinary collaboration across clinical specialties, laboratories and imaging services to integrate translational endpoints and ensure operational feasibility of complex trial designs.
Participate in data safety monitoring board (DSMB) meetings, present safety and recruitment data, and coordinate implementation of DSMB recommendations and protocol amendments.
Maintain continuous professional development including up-to-date GCP certification, research methodology training and attendance at relevant conferences; incorporate best practices to enhance trial conduct.
Ensure participant confidentiality and data protection in accordance with local laws and institutional policies (e.g., GDPR), including secure handling of identifiers and access-controlled research records.
Coordinate patient follow-up activities including scheduling visits, telephone follow-up, long-term outcome tracking and integration with electronic medical records where applicable.
Support translational research activities by coordinating sample collection schedules, ensuring appropriate processing, storage and documentation for downstream assays (e.g., genomics, biomarker analysis).

Secondary Functions

Provide cover and clinical expertise for other research staff during investigator absences and support cross-site coordination for multi-center trials.
Contribute to patient and public involvement (PPI) initiatives by helping design patient-facing materials, consent forms and recruitment outreach to improve engagement and diversity in trials.
Assist with feasibility assessments and site selection for new studies, providing clinical input about workflow impact, recruitment potential and resource requirements.
Participate in departmental teaching and training programs, presenting research updates and promoting a culture of academic enquiry among clinical teams.
Support ad-hoc quality improvement projects that streamline research workflows, reduce administrative burden and improve participant experience.
Collaborate with laboratory and data science colleagues to troubleshoot sample or data quality issues and implement corrective measures.
Help prepare lay summaries and dissemination materials for funders and public stakeholders, translating complex research findings into accessible formats.
Support institutional research governance processes by contributing to standard operating procedure (SOP) updates, safety escalations and internal reporting mechanisms.

Required Skills & Competencies

Hard Skills (Technical)

Demonstrable knowledge and certification in ICH-GCP (Good Clinical Practice) with experience applying GCP to interventional and observational studies.
Experience designing and authoring clinical trial protocols, informed consent forms (ICFs) and study manuals, including protocol amendments.
Proven ability to perform eligibility screening, informed consent and clinical assessments in accordance with trial protocols.
Practical experience with electronic data capture (EDC) systems such as REDCap, Medidata Rave, OpenClinica or similar, and familiarity with CTMS (Clinical Trial Management Systems).
Strong understanding of regulatory submissions and approvals (IRB/REC, MHRA, FDA) including safety reporting requirements and regulatory timelines.
Experience with SAE/AEs reporting and pharmacovigilance processes, including use of MedDRA terminology and expedited reporting workflows.
Competence in source data verification (SDV), CRF completion, data cleaning and query resolution processes to ensure dataset integrity.
Familiarity with biological sample handling, biobanking procedures, cold chain logistics and laboratory liaison for biomarker or translational studies.
Experience collaborating with statisticians, drafting statistical analysis plans (SAPs) and interpreting clinical trial results; basic statistical literacy (e.g., familiarity with R or SAS is advantageous).
Track record of manuscript writing, abstract submission and presentation development for conferences and peer-reviewed journals.
Budget management and grant administration experience, including monitoring study costs and liaising with research finance.
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) and collaborative platforms (Teams/Zoom) for documentation and communication.
Experience participating in DSMB/IDMC processes and acting on data safety and interim analysis recommendations.

Soft Skills

Excellent verbal and written communication skills for interacting with patients, clinical teams, sponsors and regulatory bodies.
Strong organizational skills with attention to detail and ability to manage multiple concurrent studies and competing deadlines.
Leadership and mentoring capabilities to supervise junior research staff and foster a high-performance team culture.
Problem-solving mindset with the ability to triage operational issues and implement pragmatic corrective actions quickly.
Empathy and patient-centered approach when discussing research participation, risks and follow-up requirements with participants and families.
High ethical standards and professional integrity, with a commitment to data confidentiality and research governance.
Adaptability and resilience in dynamic clinical research environments, including managing protocol changes and recruitment challenges.
Collaborative team player who builds effective working relationships across clinical, laboratory and administrative teams.
Time management and prioritization skills to balance clinical duties, research deliverables and academic outputs.
Influencing and negotiation skills to secure departmental buy-in, site resources and engagement for research projects.

Education & Experience

Educational Background

Minimum Education:

MBBS/MBChB or equivalent medical degree (fully registered with the appropriate medical council) or a PhD in a relevant biomedical field with clinical research experience.

Preferred Education:

Postgraduate clinical qualification (MRCP, FRCS, or specialty traineeship) and/or higher research degree (MD, PhD) in clinical or translational science.
Formal training or certification in Good Clinical Practice (GCP), clinical trial methodology or research governance.

Relevant Fields of Study:

Clinical Medicine / Internal Medicine / Surgical Specialties
Clinical Research / Translational Medicine
Biomedical Sciences, Pharmacology or Public Health
Epidemiology / Biostatistics

Experience Requirements

Typical Experience Range: 1–5 years of clinical practice combined with 1–3 years of research experience (postgraduate research or prior research fellowship experience is common).

Preferred:

Prior hands-on experience in clinical trial conduct as an investigator, sub-investigator or research fellow, including patient recruitment, consent and onsite study coordination.
Experience working on interventional trials (Phase I–III), device studies or complex translational projects, ideally within the specialty area advertised (e.g., oncology, cardiology, neurology).
Demonstrated record of academic outputs (abstracts, conference presentations, peer-reviewed publications) and contribution to grant applications or funding proposals.
Experience with multi-center trial coordination and interaction with sponsors/CROs, including site initiation and monitoring processes.