[Remote] Senior Regional Clinical Research Associate at Corcept Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, BiotechnologyIndustries

Requirements

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
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

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
Collect and maintain 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
Conduct 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

Skills

Key technologies and capabilities for this role

GCPICH guidelinesSOPssite monitoringsource data verificationprotocol adherencesafety reportingpatient recruitmentCRF completionclinical trial managementremote monitoringon-site visits

Questions & Answers

Common questions about this position

What are the main responsibilities of the Senior Regional Clinical Research Associate?

The role involves managing site activities across qualification, initiation, monitoring, and close-out; ensuring compliance with GCP, ICH guidelines, and SOPs; and handling site monitoring, regulatory documentation, and relationship management.

Is this a remote position or does it require on-site work?

The position involves both remote and on-site visits for site monitoring and oversight.

What compliance standards must the SRCRA follow?

The role requires adherence to GCP, ICH guidelines, and Corcept SOPs for site performance, regulatory documentation, and safety reporting.

What communication duties does the SRCRA have with sites and team members?

The SRCRA acts as the main point of contact for site staff, maintains regular communication with the Lead RCRA, drafts visit reports, and meets with the Principal Investigator to discuss findings.

What experience or skills make a strong candidate for this role?

Strong candidates will have expertise in clinical site monitoring, regulatory compliance, GCP/ICH/SOP adherence, site relationship management, and experience with both remote and on-site visits.

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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