Clinical Research Associate – CRA II/Senior, Metabolic

This is a fully remote position, open to applicants in Alabama, +42 more states.

📋 Description

• Oversee clinical sites from their identification to the final closeout.

• Act as the main point of contact for designated clinical sites.

• Execute qualification, site initiation, monitoring, and termination visits at assigned clinical sites.

• Generate timely reports for visits and contacts.

• Ensure quality and delivery standards at sites are maintained.

• Address inquiries from sites and resolve any arising issues.

• Maintain study integrity and foster relationships with investigators and site personnel.

• Assess trial performance while protecting the rights, safety, and welfare of study participants.

• Formulate patient recruitment strategies to meet enrollment timelines.

• Guarantee adherence to SOPs, study protocols and amendments, Good Clinical Practice, and regulatory standards.

• Analyze reported data quality and integrity, site performance, and accountability of investigational products.

• Supervise the completeness and quality of regulatory documentation.

• Conduct verification of site documents.

⛳️ Requirements

• Minimum of 18 months of direct onsite monitoring experience as a Clinical Research Associate.

• Experience in monitoring clinical trials related to Metabolic/MASH and/or Obesity.

• Bachelor’s degree or equivalent in biological science, pharmacy, or another health-related field.

• Familiarity with Good Clinical Practice, relevant regulatory requirements, and clinical trial operations.

• Proficient in using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word.

• Strong skills in site relationship management, problem-solving, communication, interpersonal relations, written and verbal communication, organization, and attention to detail.

• Capability to work independently with a sense of urgency and minimal oversight.

• Proficient in managing multiple priorities, assessing evolving scenarios, applying study protocols, and adhering to project timelines.

• Ability to collaborate effectively within a matrixed team and communicate clearly with both internal and external stakeholders.

• Ethical, patient-centered approach to work.

• Must be eligible to work in the United States.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.

• Potential eligibility for additional incentives, bonuses, or other compensation programs.