Senior Clinical Research Associate – CRO-Contract

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

📋 Description

• Manage and oversee site activities independently for designated clinical studies.

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

• Ensure adherence to protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines.

• Execute site evaluation visits and assess the capabilities of investigators’ sites.

• Facilitate study initiation activities, review protocols and regulatory matters, and provide training for site personnel.

• Maintain Investigator Site Files in an audit-ready state and ensure documents are uploaded to the Trial Master File.

• Communicate with investigational sites regarding visit planning, query resolution, action items, and overall site management.

• Document accountability of clinical trial materials, stability, and storage conditions; conduct inventory of investigational products.

• Coordinate site correspondence and guarantee timely transmission of clinical data.

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

• Complete internal and study-related training within stipulated timelines.

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

• Collaborate with the CRA Line Manager in mentoring, training, and assessing CRAs and junior staff as necessary.

⛳️ Requirements

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

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

• Proficient in the responsibilities associated with the CRA II position.

• Valid Driver’s License required.

• Legally permitted to work in the US as an independent contractor (LLC or INC.) or via an agency.

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

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

• Proficient in utilizing electronic CRF platforms and processes.

• Strong interpersonal, organizational, and multitasking abilities.

• Exceptional attention to detail and sound professional judgment.

• Capability to uphold ICH GCP guidelines and address complex problems appropriately.

• Ability to handle multiple deadlines and work autonomously.

• Proficient in computer skills and familiarity with email, document, spreadsheet, and presentation software.

• Ability to submit invoices and expense reports promptly in accordance with Finance Department requirements.

• Must be able to meet physical demands, including occasional lifting or carrying up to 10 pounds.

• Adherence to safety, environmental, infection control, and protective equipment protocols when traveling or visiting clinical research sites.

🏝️ Benefits

• Contractor is responsible for obtaining their own insurance.

• Option for a home office environment.

• Opportunity to assist in mentoring, training, and evaluating CRAs and junior staff.