Lead – Clinical Research Associate

From 3 to 7 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

Clinical Research Associate:

Overview of the role

  • Monitoring of clinical study 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
    • Perform Site Identification and conduct Feasibility Studies
    • Perform Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit
    • Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required
    • Training of Investigators/ sites on Protocol and other applicable regulatory guidelines including local regulatory guidelines
    • Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities
    • Coordinate for Ethics Committee Submission by sites
    • Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
    • Verify drug accountability logs and storage requirements
    • 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 and facilitate project timelines
  • Updation of clinical study trackers (including study update/ finance)
  • Maintain accurate and timely sponsor/ CRO/ SMO /site correspondence and communication
  • Primary point of contact for Clinical Operations aspects of designated study sites/ CRO/ SMO
  • May be required to help in preparation of Regulatory Binder (Preparation and submission of clinical documents for International Regulatory Dossiers as per the country standard formats)
  • Maintain updated Site Files and collection of the essential documents and project related documents and maintain Central Study File
  • Coordinate and distribute Clinical Study Material to study sites.
  • Coordination of Archival of study documents


Desired Candidate Profile

  • Degree (Graduation or Post Graduation) in science or pharmacy (BSc/BDS/ B.Pharm/ M. Pharm/ M.Sc) with 2-3 years of experience with clinical study monitoring at sponsor or CRO company is preferred. Working as study site coordinator” at reputed institute (in clinical operation) may also apply
  • 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%.


Education

PG:M.Pharma in Any Specialization

Company Profile

The Himalaya Drug Company

Working in Himalayas means to learn and grow continuously.Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world class working environment, professional management and ample prospects to train and learn along with exceptional rewards.
Company Info
X
View Contact Details+

Contact Company:The Himalaya Drug Company

Address:THE HIMALAYA DRUG COMPANY,,THE HIMALAYA DRUG COMPA, NY,TUMKUR ROAD,MAKALI, BANGALORE, Karnataka, India

Salary:

Not Disclosed by Recruiter

Role Category:

Healthcare & Life Sciences - Other

Role:

Healthcare & Life Sciences - Other

Employment Type:

Full Time, Permanent