Senior Clinical Research Associate – CRO Contract

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

📋 Description

• Oversee and monitor site operations for designated clinical studies independently.

• Execute site qualification, initiation, interim monitoring, and close-out visits.

• Conduct evaluations of sites and assess the capabilities of investigators.

• Facilitate study initiation tasks, review protocols and regulatory matters, and provide training to site staff.

• Maintain Investigator Site Files in audit-ready condition and ensure timely document uploads to the Trial Master File.

• Engage directly with investigational sites concerning visit planning, query resolutions, action items, and site management.

• Document accountability, stability, and storage conditions of clinical trial materials.

• Manage investigational product inventory and oversee the return or destruction of unused items.

• Act as the primary contact for sites, coordinating correspondence and the timely transmission of clinical data.

• Conduct study close-out visits, reconcile investigational products and site files, resolve queries through database lock, and address outstanding actions.

• Complete both internal and study-related training within specified timelines.

• Perform pre- and post-visit follow-ups, including confirmation letters, follow-up letters, and monitoring visit reports.

• Collaborate with the CRA Line Manager to mentor, train, and assess CRAs and junior staff as needed.

• Adhere to safety practices while traveling and visiting clinical research sites.

⛳️ Requirements

• Bachelor’s degree or equivalent experience in life sciences or healthcare.

• Minimum of 5 years of field experience as a CRA in clinical research.

• Proficient in the responsibilities of a CRA II.

• Valid Driver's License required.

• Must be legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency.

• Willingness and ability to travel up to 100% of the time, both domestically by land and air.

• In-depth knowledge of the drug development process, ICH guidelines, GCP, and clinical trial processes.

• Skilled in using electronic CRF platforms and procedures.

• Strong interpersonal, organizational, and attention-to-detail skills.

• Ability to work independently, manage multiple responsibilities, and meet various deadlines.

• Competent computer skills with a working knowledge of email, document, spreadsheet, and presentation software.

• Capable of submitting invoices and expense reports following Finance Department requirements.

• Knowledge of safety, environmental, infection control, and personal protective equipment guidelines.

• Ability to lift and/or carry up to 10 pounds.

🏝️ Benefits

• The contractor is responsible for their own insurance.

• Home office environment available.

• Opportunities for travel-related work.