[Remote] Senior Regional Clinical Research Associate at Corcept Therapeutics

Remote

Apply Now

Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

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
Excellent written and verbal communication skills
Proven problem-solving and analytical skills
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
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

Skills

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.

Land your dream remote job 3x faster with AI

Try Jobo Free