Senior Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Act as the main liaison between investigational sites and the sponsor.

• Perform site selection, initiation, routine monitoring, and close-out visits.

• Ensure compliance of sites with ICH-GCP, SOPs, and applicable regulations.

• Keep documentation current in CTMS and eTMF systems.

• Assist in tracking site staff training and maintaining compliance records.

• Monitor patient safety, guaranteeing timely and accurate reporting of AEs, SAEs, and PQCs.

• Aid in subject recruitment and retention at the site level.

• Supervise drug accountability and ensure appropriate storage, return, or destruction.

• Address data queries and facilitate timely, high-quality data entry.

• Record site progress and escalate any risks or issues to the clinical team.

• Assist in monitoring site budgets and ensuring timely payments as necessary.

• Collaborate with CTAs, LTMs, and CTMs.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related field, or qualified RN.

• Must be eligible to work in the United States without visa sponsorship.

• A minimum of 3 years of on-site monitoring experience in the pharmaceutical or CRO sector.

• Experience across various therapeutic areas, ideally including Oncology and Hematology.

• Strong knowledge of ICH-GCP and local regulatory standards.

• Proficient in clinical systems such as CTMS and eTMF.

• Willing and able to travel up to 50% for on-site monitoring visits throughout the northeast region.

• Preference for candidates located in New Jersey or New York near major hub airports.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.