Clinical Trial Specialist

Responsibilities

• Coordinate the initiation and activation of all new clinical trial protocols, ensuring necessary approvals and data collection plans are in place.
• Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
• Develop study tools using computer software such as Excel® and Word®.
• Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical history for protocol eligibility.
• Ensure that informed consent forms are obtained, signed, and properly documented in medical records.
• Register consented research patients with study sponsors and maintain records in the clinical trials database.
• Maintain comprehensive research records for all patients enrolled in clinical trials.
• Assist with grading adverse events and complete necessary forms for serious/unexpected adverse events.
• Provide regular reports to tumor study groups and Principal Investigators on assigned studies.
• Serve as a liaison with study sponsors, schedule monitoring visits, and respond to sponsors’ queries.
• Ensure that personnel, including investigators, conduct studies according to treatment plans and Good Clinical Practice (GCP) guidelines.

Essential Skills

• 2-3 years of experience as a Clinical Research Coordinator.
• Experience in clinical research, particularly in oncology.
• Proficiency in managing informed consent and source documents.
• Ability to recruit and enroll patients.
• Comfortable communicating with patients.

Additional Skills & Qualifications

• Bachelor’s Degree required.
• Solid knowledge of computer software programs such as Excel®, Word®, and Access®.
• Detail-oriented with excellent organizational, communication, and interpersonal skills.
• Ability to hold oneself accountable to high standards of professional excellence.
• Resourceful and able to maximize resources effectively.