Clinical Research Associate – CRA II/Senior

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

📋 Description

• Oversee clinical sites from the initial identification phase through to the closeout phase.

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

• Perform qualification visits, site initiation visits, monitoring visits, and termination visits.

• Generate timely reports for visits and contacts.

• Ensure site quality and performance are maintained throughout the study lifecycle.

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

• Maintain study integrity while fostering relationships with investigators and site personnel.

• Evaluate trial performance, ensuring the protection of participant rights, safety, and well-being.

• Create patient recruitment strategies in collaboration with clinical sites to meet enrollment timelines.

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

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

• Monitor the completeness and quality of regulatory documentation.

• Conduct verification of site documents.

• Carry out onsite monitoring activities while supporting enrollment and study delivery.

⛳️ Requirements

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

• Required experience in monitoring clinical trials related to Oncology, Ophthalmology, Metabolic, Hematology, or CAR-T.

• 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 methodologies.

• Proficiency 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 interactions, written and verbal communication, organization, and attention to detail.

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

• Ability to juggle multiple priorities, assess changing scenarios, apply study protocols, and adhere to project timelines.

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

• Ethical and patient-centered approach.

• Client-focused and adaptable approach to tasks with a commitment to continuous learning.

🏝️ 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 plan terms.

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