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Corcept Therapeutics · 4 weeks ago

Senior Regional Clinical Research Associate

United States

Full-time

Remote

Senior Level

$125K/yr - $178K/yr

6+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators aimed at treating serious diseases. The Senior Regional Clinical Research Associate serves as the primary liaison to clinical trial sites, responsible for managing site activities and ensuring compliance with regulatory guidelines throughout the clinical trial process.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Conduct qualification, initiation, interim, and close-out visits both remotely and on-site

Act as the main point of contact for site staff and ensure consistent communication throughout the study

Monitor site performance, including recruitment, enrollment, source data verification, protocol adherence, safety reporting, and data query resolution

Meet with the Principal Investigator during visits to discuss findings and next steps

Train site staff on protocol requirements, source documentation, and CRF completion

Prepare and submit visit reports and correspondence in accordance with the monitoring plan and SOPs

Responsible for the collection and maintenance of regulatory documentation

Ensure accurate and timely IRB/EC submission, communication, and approvals are maintained within the Investigator Site File (ISF)

Reconcile ISF contents with Corcept’s eTMF to ensure completeness and accuracy

Responsible for conducting Investigational Product (IP) accountability and reconciliation, document destruction and return, and monitor re-supply and storage conditions

Ensure timely and appropriate SAE reporting and submission to IRBs

Draft and deliver confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV)

Maintain regular communication with the Lead RCRA (LRCRA) to report on site progress and resolve issues

Assess site readiness and resourcing (personnel, facilities, supplies) for trial conduct

Collaborate with vendors (e.g., central lab, imaging core) to resolve operational issues

Lead or participate in co-monitoring, oversight, and training visits as needed

Qualification

Clinical trial experienceFDA regulations knowledgeICH-GCP guidelines familiarityMicrosoft Office proficiencyOrganizational skillsWritten communicationVerbal communicationProblem-solving skillsLeadership experience