Senior Clinical Research Associate

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

📋 Description

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

• Perform site selection, initiation, regular monitoring, and closure visits.

• Ensure that sites adhere to ICH-GCP, SOPs, and relevant regulations.

• Keep documentation updated in CTMS and eTMF systems.

• Assist and track training and compliance records of site staff.

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

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

• Oversee drug accountability, ensuring proper storage, return, or destruction.

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

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

• Manage site budgets and ensure timely payments are made as necessary.

• Collaborate with CTAs, LTMs, CTMs, and various cross-functional partners.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or equivalent qualification, or a qualified RN.

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

• At least 2 years of on-site monitoring experience in the pharmaceutical or CRO industry.

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

• Oncology experience should ideally cover Prostate Cancer and Lung Cancer.

• Knowledgeable in ICH-GCP and local regulatory requirements.

• Skilled in using CTMS and eTMF clinical systems.

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

• Preference will be given to candidates residing in Cincinnati, OH, near major HUB airports.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

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