Senior Clinical Research Associate

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

📋 Description

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

• Perform various types of site visits, including selection, initiation, routine monitoring, and close-out.

• Ensure compliance of the site with ICH-GCP, SOPs, and regulations.

• Keep documentation current in CTMS and eTMF systems.

• Assist with and monitor training for site staff while maintaining compliance records.

• Oversee patient safety by ensuring timely and accurate reporting of AEs/SAEs/PQCs.

• Aid in the recruitment and retention of subjects at the site level.

• Manage drug accountability and ensure proper storage, return, or destruction of materials.

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

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

• Help track site budgets and ensure timely payments to sites, as applicable.

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

⛳️ Requirements

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

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

• A clinical research professional with over 3 years of on-site monitoring experience in the pharmaceutical or CRO sector.

• Experienced in monitoring Oncology (e.g., Prostate Cancer and Lung Cancer) and/or Hematology oncology trials.

• Knowledgeable in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.

• Strong communicator, problem-solver, and cooperative team player.

• Willingness and ability to travel up to 50% for on-site monitoring visits throughout the southeastern region; preference will be given to candidates residing in Knoxville, TN, close to major HUB airports for efficient regional travel.

🏝️ 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 offered.

• Life assurance and disability coverage available.

• Employee assistance programs and wellness resources provided.

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