Senior Clinical Research Associate – FSP

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assist in selecting potential investigators.

• Aid in study start-up and regulatory upkeep, including site qualification visits and submissions to regulatory bodies, EC, and IRB as necessary.

• Train, support, and guide investigators and site personnel on study-related issues, incorporating Risk Based Quality Management principles.

• Confirm that site staff complete necessary training, including ICH-GCP training, and ensure readiness for inspections.

• Participate in Local Study Team meetings and National Investigators meetings as required.

• Initiate, monitor, and close study sites in accordance with client protocols.

• Enhance site performance, pinpoint and address study-related challenges, and escalate issues as needed.

• Update the CTMS and other systems with study-site information within stipulated timelines.

• Manage study supplies, drug inventory, and drug accountability; prepare study drugs for disposal when necessary.

• Conduct both remote and onsite monitoring visits as well as remote data verification in line with the Study Monitoring Plan.

• Execute Source Data Review, Case Report Form review, and Source Data Verification.

• Carry out Site Quality Risk Assessments and adjust monitoring intensity accordingly.

• Ensure prompt resolution of data queries and collaborate with data management to maintain study data quality.

• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups.

• Prepare and finalize monitoring visit reports in the CTMS and provide timely feedback to Principal Investigators.

• Follow up on outstanding actions required from study sites.

• Escalate systemic or serious quality concerns, privacy violations, protocol deviations, and ICH-GCP compliance issues.

• Assist sites in keeping Investigator Site Files ready for inspections.

• Prepare for and collaborate on audits and regulatory inspections.

• Ensure timely collection and upload of essential documents into the eTMF and support quality control checks.

• Ensure study documents are prepared for final archiving and local eTMF completion.

• Provide research-related insights on sites, investigators, and competing studies in the local market.

• Collaborate with local Medical Scientific Liaisons as directed.

⛳️ Requirements

• Exceptional attention to detail.

• Strong written and verbal communication skills.

• Effective collaboration and interpersonal skills.

• Proficient negotiation abilities.

• Proficiency in written and spoken English is essential.

• Comprehensive knowledge of international ICH-GCP guidelines.

• Basic understanding of GMP/GDP.

• Familiarity with relevant local regulations.

• Solid medical knowledge and the capacity to learn about relevant Client Therapeutic Areas.

• Basic comprehension 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 field, preferably in life sciences, or equivalent qualifications suited to local market needs.

• Willingness to travel nationally and internationally as necessary.

• Valid driving license according to country-specific requirements, where applicable.

🏝️ Benefits

• Remote work arrangement.

• Full-time employment.