Lead - Clinical Research Associate

"Lead - Clinical Research Associate","career_text":"

Overview of the role
- Lead clinical studies to ensure that study is conducted in compliance with the protocol, Sponsors SOPs, Good Clinical Practice (GCP) and relevant regulatory guidelines
- Perform following monitoring activities directly or mange through SMO/ CRO
o Perform/ Review/ Oversee Site Identification and conduct Feasibility Studies
o Perform/ Review/ Oversee Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit
o Ensure Follow Up letters to sites are sent and submit Visit Reports to the Clinical Project Manager as required
o Training of study team/ clinical sites on Protocol and other applicable regulatory guidelines including local regulatory guidelines
o Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities along with internal stakeholders
o Ensure timely Ethics Committee Submission by sites
o Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
o Verify drug accountability at sites and at Himalaya and supply/ resupply of study materials
o Timely CRF retrieval as per the project instructions
- Support the Clinical Project Manager in overall management of the assigned studies. Provide study status updates to team members and project management team and facilitate timely completion of projects
- Updation of clinical study trackers (including study update/ finance tracking)
- Maintain accurate and timely sponsor/ CRO/ SMO /site correspondence and communication
- Primary point of contact for Internal stakeholders including Clinical Project Manager, PMD, DSG, FD etc.
- Ensure Central Site Files and Project Management Files are up to date and conduct period review as per SOP/ project requirements
- Coordination for Archival of study documents (Both in soft copies and hard copies).

Role Requirements:
- Degree (Graduation or Post Graduation) in science or pharmacy (BSc/BDS/ B.Pharm/ M. Pharm/ M.Sc) with 8-10 years of experience with clinical study monitoring at sponsor or CRO company is preferred.
- A satisfactory previous experience of monitoring clinical trial activities
- Must have thorough knowledge of clinical trial concepts including ICH GCP and relevant regulations for the conduct of clinical trials
- Fluent in written and spoken English proficient in MS Office.
- It may be required for the employee to travel up-to approx. 25- 50%.