Senior Clinical Research Associate, Cell & Gene Therapy

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage all facets of clinical monitoring and site management while adhering to GCP, global regulatory standards, and WEP Clinical SOPs.

• Perform both on-site and remote monitoring to ensure compliance with protocols.

• Keep essential documentation organized and ensure that site and patient data is ready for inspection.

• Establish robust relationships with sponsors and site personnel.

• Act as a central point of contact throughout the duration of the study.

• Contribute to the creation of study-specific procedures, such as Monitoring Plans.

• Aid in the training or organization of other Clinical Research Associates (CRAs).

⛳️ Requirements

• A Bachelor’s degree in life sciences, nursing, or a related discipline is preferred.

• 5–7+ years of experience in conducting both on-site and remote monitoring visits, or equivalent clinical research experience.

• Senior CRA levels: **SCRA I (3–5 years)** – independently manages complex sites; **SCRA II (5+ years)** – supervises intricate sites/regions, mentors colleagues, and spearheads process enhancements.

• Extensive therapeutic knowledge across various study types and indications.

• Strong technical and scientific skills with the capacity to swiftly understand and implement clinical protocols.

• Exceptional organizational and logistical abilities; capable of managing multiple sites/protocols within budget and time constraints.

• Outstanding written and verbal communication skills; confident in engaging with stakeholders.

• Robust understanding of medical and therapeutic domains along with medical terminology.

• Demonstrated capability to train, coach, and mentor clinical research personnel.

• Proficient in MS Office and EDC systems; willing to travel up to 80% of the time.

• Ability to maintain a stationary position for prolonged periods as part of routine activities, with reasonable accommodations considered when necessary.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Flexible Spending Account (FSA) and Health Savings Account (HSA).

• Optional Critical Illness, Hospital Indemnity, and Accident Insurance.

• Group short-term and long-term disability insurance.

• Group Life Insurance.

• 401K safe harbor plan with company matching contributions.

• Paid vacation, holidays, sick leave, and volunteer time.

• Paid maternity and paternity leave.