Job Description
Role:
Senior Clinical Research Associate
Key Responsibilities
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, Standard Operating Procedures and all the applicable Good Clinical Practice (GCP) Guidelines and Regulations.
- Responsible for site management for the assigned protocols, sites and therapeutic areas
- Complete appropriate Standard Operating procedure training, therapeutic area training, protocol training and any relevant training required to perform job duties
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectation and activities
- Ensure the quality and integrity of study conducted at site level in accordance with protocol and applicable regulations. Investigate and discuss quality issues with Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action
- Manage the progress and performance of the assigned study sites by following activities but not limited to: tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentations.
- Provide assistance to the Clinical Project Manager with design of study tools, documents and processes.
- Timely submission of timesheets for Project specific and other tasks.
- Assignment as a Lead Clinical Research Associate (if required), the responsibilities could include:
- Supporting the Clinical Project Manager for coordination with-in the project team.
- Delegation of project level Clinical Project Manager responsibilities
- The above responsibilities would be assigned by reporting manager and project-level task allocation would be performed.
Educational Qualification
M. Sc/M. Pharm/Pharm D, BAMS, BDS, MDS & BHMS/Any life science
Experience
3 – 9 Years
Behavioural Skills
- Should have good communication skill and should be a good team player.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should be a focused employee.