Clinical Research Associate Job Openings at Premier Research, Apply Now!
Apply now for a Clinical Research Associate II job (remote) with Premier Research, a leading global CRO specializing in biotech, medtech, and specialty pharma clinical trials. This full-time remote CRA role based in India involves clinical trial monitoring, data validation, and site management for studies in oncology, rare diseases, and other therapeutic areas. Join a team that’s transforming breakthrough science into life-saving innovations.
Clinical Research Associate II
Remote type: Remote
Locations: India
Time type: Full time
Posted on: Yesterday
Time left to apply: End Date: July 18, 2025 (10 hours left to apply)
Job Requisition ID: R5425
Premier Research is looking for a Clinical Research Associate II to join our Global Clinical Monitoring and Site Management team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for Biotech™. Join us and build your future here.
What You’ll be Doing:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
- Maintains submission of expenses according to travel and expense requirements within company guidelines.
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements.
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.
- Plans day to day activities for monitoring of a clinical study and sets priorities per site.
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section.
- Reviews site documents and verifies they are accurate, complete, current, and include required updates.
- Assists project team with assessing project feasibility and recruitment, as applicable.
- Maintains project tracking system of subjects and site information, as applicable.
- Participates in Investigators’ Meeting as designated by the Project Manager.
- Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts. Attends meetings as required.
- Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager.
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan.
What we are searching for: - Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution. Previous clinical research experience required, completion of CRA training program.
- At least 2+ years’ experience in clinical trials to include independent monitoring to qualify for a CRA II.
- There will be an expectation for countrywide monitoring and should be prepared for, on average, 8 days per month monitoring.
- We are looking for knowledge across a broad range of therapeutic areas so experience within at least some, if not, all of the following is needed; Oncology, Rare Diseases.
Keywords: Clinical Research Associate II, Premier Research, Remote, Job Opportunity, India, Clinical Trials, Monitoring, Therapeutic Areas. Clinical Research Associate Job Openings
