Senior Regional Clinical Research Associate at Corcept Therapeutics

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Full Time

Start Date

Immediate

Expiry Date

12 Feb, 26

Salary

178000.0

Posted On

14 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Organizational Skills, Time Management, Communication Skills, Problem-Solving, Analytical Skills, Leadership, Mentoring, Training, Regulatory Knowledge, Clinical Terminology, FDA Regulations, ICH-GCP Guidelines, Site Monitoring, Data Verification, Patient Recruitment, Documentation Compliance

Industry

Biotechnology Research

Description

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Senior Regional Clinical Research Associate (SRCRA) serves as the primary liaison to clinical trial sites participating in Corcept-sponsored studies. This role is responsible for managing site activities across all stages—qualification, initiation, monitoring, and close-out. The SRCRA ensures patient recruitment, enrollment, and overall site performance are aligned with GCP, ICH guidelines, and Corcept SOPs. Responsibilities: Site Monitoring & Oversight 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 Regulatory and Documentation Compliance 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 Site Communications & Relationship Management 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 Preferred Skills, Qualifications and Technical Proficiencies: Strong organizational and time management skills; capable of managing multiple priorities and deadlines Excellent written and verbal communication skills; adept in regulatory and clinical terminology Proven problem-solving and analytical skills Leadership experience with the ability to mentor and train junior CRAs Proficiency in Microsoft Word, Excel, and PowerPoint In-depth knowledge of FDA regulations and industry practices Willingness to travel up to 80% regionally, with occasional cross-country travel Preferred Education and Experience: Bachelor’s degree in science, healthcare, or nursing 6+ years of clinical trial experience, including at least 4 years as a regional field-based CRA Familiarity with ICH-GCP guidelines and the ability to assess medical data The pay range that the Company reasonably expects to pay for this position is $125,400 - $178,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. #LI-Remote Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Responsibilities

The Senior Regional Clinical Research Associate serves as the primary liaison to clinical trial sites, managing site activities across all stages of clinical trials. Responsibilities include site monitoring, regulatory compliance, and maintaining effective communication with site staff and stakeholders.