Senior Clinical Research Associate, Cell & Gene Therapy

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• Oversee all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs • Conduct on-site and remote monitoring to ensure protocol adherence • Maintain essential documentation and keep site and patient data inspection-ready • Build strong relationships with sponsors and sites • Serve as a key point of contact throughout the study • Support development of study-specific procedures (e.g., Monitoring Plans) • Assist in training or coordinating other CRAs

🎯 Requirements

• Bachelor’s degree (life sciences, nursing, or related field preferred) • 5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience) • Senior CRA levelling: **SCRA I (3–5 yrs)** – independently manages complex sites; **SCRA II (5+ yrs)** – oversees complex sites/regions, mentors peers, and drives process improvements • Broad therapeutic exposure across multiple study types and indications • Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols • Advanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelines • Excellent written and verbal communication; confident stakeholder engagement • Solid understanding of medical/therapeutic areas and medical terminology • Proven ability to train, coach, and mentor clinical research staff • Proficient with MS Office and EDC systems; willing to travel up to 80% • Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

🏖️ Benefits

• Medical, dental, and vision insurance • FSA, HSA • Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance • Group short-term and long-term disability insurance • Group Life Insurance • 401K safe harbor plan and company match • Paid vacation, holiday, sick and volunteer time • Paid maternity & paternity leave