Clinical Research Associate

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

📋 Description

• Conduct qualification, site initiation, monitoring, and termination visits at designated clinical sites.

• Prepare visit and contact reports promptly.

• Manage site quality and delivery from the identification stage through to closeout.

• Act as the primary liaison for assigned clinical sites.

• Address questions from sites and resolve issues to ensure successful study execution.

• Oversee the integrity of studies and foster strong relationships with investigators and site personnel.

• Review trial performance, ensuring the rights, safety, and well-being of study participants are protected.

• Collaborate with clinical sites to develop patient recruitment strategies that align with enrollment timelines.

• Ensure adherence to SOPs, study protocols and amendments, Good Clinical Practice, and relevant regulatory requirements.

• Assess the quality and integrity of reported data, site performance, and investigational product accountability.

• Monitor the completeness and quality of regulatory documentation.

• Conduct verification of site documents.

⛳️ Requirements

• A minimum of 12 months of direct onsite monitoring experience as a Clinical Research Associate.

• Bachelor's degree or equivalent in biological sciences, pharmacy, or a related health discipline.

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

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

• Excellent interpersonal, written, and verbal communication skills, alongside strong organizational and problem-solving abilities.

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

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

• Comfort in collaborating within a matrixed team and effectively communicating with both internal and external stakeholders.

• Preferred experience in monitoring clinical trials related to Oncology, Ophthalmology, CAR-T, and/or MASH.

🏝️ 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.

• Additional benefit offerings in accordance with applicable plans.

• Certain roles may qualify for extra incentives, bonuses, or other compensation programs.