Senior Clinical Research Coordinator Interview Questions and Answers

SAE stands for Serious Adverse Event. Responsibilities include reporting, documenting, and managing adverse events in clinical trials.

• SAEs are unexpected, serious adverse reactions that occur during a clinical trial

• Responsibilities include promptly reporting SAEs to regulatory authorities and ethics committees

• Documenting all details of the SAE, including severity, outcome, and relationship to the study drug

• Managing the SAE by ensuring appropriate medical care is provided to t...read more

Phase of clinical trial, scope in clinical trials, EC dossier submission process

• Phase of clinical trial refers to the stage of testing a new treatment in humans, such as Phase I, II, III, or IV

• Scope in clinical trials involves determining the objectives, design, and methodology of the study

• EC dossier submission process involves preparing and submitting documentation to the Ethics Committee for approval

The different phases of clinical trials are Phase 1, Phase 2, Phase 3, and Phase 4.

• Phase 1: Small-scale trial to assess safety and dosage in a small group of healthy volunteers.

• Phase 2: Larger trial to evaluate effectiveness and side effects in a larger group of patients.

• Phase 3: Large-scale trial to confirm effectiveness, monitor side effects, and compare to existing treatments.

• Phase 4: Post-marketing surveillance trial to monitor long-term effects and safety in a larger pop...read more

A Senior Clinical Research Coordinator (CRC) is responsible for overseeing and managing clinical research studies.

• Designing and implementing research protocols

• Recruiting and screening study participants

• Collecting and analyzing data

• Ensuring compliance with regulatory guidelines

• Managing study budgets and resources

• Coordinating with investigators, sponsors, and other stakeholders

• Preparing and submitting study reports

• Training and supervising junior CRCs

• Maintaining accurate and com...read more