Lead - Clinical Research Associate

Himalaya Wellness Company; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Himalaya Wellness Company is seeking an experienced Clinical Research Monitor to lead and oversee monitoring activities across studies, ensuring compliance with GCP, protocol and regulatory guidelines. The role requires collaboration with SMO/CRO teams and internal stakeholders, with travel to sites to support patient recruitment and study execution.

The ideal candidate holds a science/pharmacy degree with 8-10 years in clinical trial monitoring, strong English communication, and proficiency in

Qualifications

• Degree (Graduation or Post Graduation) in science or pharmacy with 8-10 years of experience in clinical study monitoring.
• Thorough knowledge of ICH GCP and relevant regulations for clinical trials.
• Fluent in written and spoken English; proficient in MS Office.

Responsibilities

• Lead clinical studies to ensure compliance with the protocol, Sponsor SOPs, GCP and regulatory guidelines.
• Perform monitoring activities directly or through SMO/CRO.
• Oversee site identification, feasibility studies, site selection visits, initiation visits, monitoring visits and closeout visits.
• Ensure timely ethics committee submissions by sites; report adverse events to sponsor and IRB/IEC.
• Maintain sponsor/CRO/SMO/site communication and update project management stakeholders.

Skills

Clinical trial monitoring

GCP knowledge

MS Office

English fluency

Travel availability

Education

Bachelors in science or pharmacy

Postgraduate in science/pharmacy (preferred)

Tools

MS Office

Job description

• 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
• Perform/ Review/ Oversee Site Identification and conduct Feasibility Studies
• Perform/ Review/ Oversee Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit
• Ensure Follow Up letters to sites are sent and submit Visit Reports to the Clinical Project Manager as required
• Training of study team/ clinical 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 along with internal stakeholders
• Ensure timely Ethics Committee Submission by sites
• Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
• Verify drug accountability at sites and at Himalaya and supply/ resupply of study materials
• 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, F&D 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).

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
• Perform/ Review/ Oversee Site Identification and conduct Feasibility Studies
• Perform/ Review/ Oversee Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit
• Ensure Follow Up letters to sites are sent and submit Visit Reports to the Clinical Project Manager as required
• Training of study team/ clinical 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 along with internal stakeholders
• Ensure timely Ethics Committee Submission by sites
• Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
• Verify drug accountability at sites and at Himalaya and supply/ resupply of study materials
• 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, F&D 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%.