Senior Clinical Research Associate
Experience, Skills, Knowledge, and Education Requirements:
- 5 to 7 years of experience in clinical operations
- Should have experience in Phase I, II, III drug trials
- Earlier experience in line management activities
- Good communication skills both oral and written are a must
- Applies strong analytical and business communication skills
- Familiarity with medical terminology and/or GCP guidelines strongly preferred
- Applies technical standards, principles, theories, concepts, and techniques
- Excellent organizational skills are required
- Demonstrated success in problem solving
- Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job
- Detail oriented
- Ability to work in a team environment
- Self-motivation, eagerness to grow professionally and commitment to self-development
- Occasional travel may be required.
- Education: Any life science degree. Preferably pharmacy (B. Pharmacy/M. Pharmacy/ PharmD)
Job Responsibilities: - Project Management
- Manage studies independently under directions of Clinical Director
- Prepare study execution strategies, challenges, and mitigations
- Forecast study expenses and support Management
- Prepare project management plans, Gantt charts, study plans
- Preparing and conducting pre- study activities, site selection, initiation visits, routine monitoring and close- out visits and performing feasibilities.
- Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities.
- Planning and participating at Investigator meeting(s) responsible for the site(s) and on- site management during the study process.
- Ordering and coordinating study supplies.
- Preparing study documentation and assisting the Clinical Quality Assurance Manager/ regulatory authorities during audits/ inspections in- house or on site.
- Negotiating contracts with the clinics, local/ central laboratory (ies)/ pharmacy etc.
- Responsibility for the final archiving of all study documentation in- house Monitoring and Oversight communicating with study teams and sponsors.
- Regulatory Documentation Management Administration Providing Status Reports to line manager.
- Planning budget activities for the trials Managing timelines and deliverables for the trials.