Clinical Research Associate – Senior, Oncology

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

📋 Description

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

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

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

• Prepare timely reports following visits and contacts.

• Manage site quality and ensure delivery throughout the entire study lifecycle.

• Address inquiries from sites and resolve issues to support the execution of the study.

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

• Review trial performance while safeguarding the rights, safety, and well-being of participants in accordance with protocols.

• Develop patient recruitment strategies in collaboration with clinical sites.

• Ensure adherence to standard operating procedures, study protocols and amendments, Good Clinical Practice, and regulatory requirements.

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

• Monitor the completeness of regulatory documentation and perform verification of site documents.

⛳️ Requirements

• Minimum of 18 months of hands-on monitoring experience as a Clinical Research Associate.

• Experience in monitoring oncology clinical trials.

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

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

• 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, writing, verbal communication, organization, and attention to detail.

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

• Ability to handle multiple priorities, assess changing scenarios, apply study protocols, and meet project deadlines.

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

• Ethical and patient-centered mindset.

• Client-oriented 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.

• Some positions may qualify for additional incentives, bonuses, or other compensation programs.