Senior Clinical Research Associate – FSP
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Job Description
Senior Clinical Research Associate managing investigator sites, monitoring visits, regulatory documents, and clinical data quality. Supporting Parexel’s clinical development solutions to improve global health outcomes.
Responsibilities:
- Contribute to the selection of potential investigators
- Support study start-up and regulatory maintenance, including site qualification visits and regulatory/EC/IRB submissions where required
- Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles
- Confirm required site staff training, including ICH-GCP training, and ensure inspection readiness
- Participate in Local Study Team meetings and National Investigators meetings as applicable
- Initiate, monitor, and close study sites in compliance with client procedures
- Drive site performance, identify and resolve study-related issues, and escalate as appropriate
- Update CTMS and other systems with study-site data within required timelines
- Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction where applicable
- Perform remote and onsite monitoring visits and remote data checks according to the study Monitoring Plan
- Perform Source Data Review, Case Report Form review, and Source Data Verification
- Conduct Site Quality Risk Assessments and adapt monitoring intensity
- Ensure timely data query resolution and collaborate with data management on study-data quality
- Ensure accurate and timely reporting of Serious Adverse Events and follow-ups
- Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators
- Follow up on outstanding site actions
- Escalate systematic or serious quality issues, privacy breaches, protocol issues, and ICH-GCP compliance issues
- Assist sites in maintaining inspection-ready Investigator Site Files
- Prepare for and collaborate on audits and regulatory inspections
- Ensure timely collection and uploading of essential documents into the eTMF and support quality-control checks
- Ensure study documents are ready for final archiving and local eTMF completion
- Provide research-related information on sites, investigators, and competing studies for the local market
- Collaborate with local Medical Scientific Liaisons as directed
Requirements:
- Excellent attention to detail
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation skills
- Proficient in written and spoken English language required
- Excellent knowledge of international ICH-GCP guidelines
- Basic knowledge of GMP/GDP
- Good knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant Client Therapeutic Areas
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management, including monitoring, study drug handling and data management
- Bachelor’s degree in a related discipline, preferably in life science, or equivalent adapted to local country market needs
- Ability to travel nationally/internationally as required
- Valid driving license per country requirements, as applicable
Benefits:
- Remote work arrangement
- Full-time employment
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