Summary

Coordinates day to day activities of research protocols which include screening, enrollment, and monitoring of research participants.  Ensures accurate data collection, documentation, organization and safety of research participants. Supervises, schedules and directs the activities of less experienced research personnel.

Job Duties

Consenting

• Interviews, screens, and recruits patients for research studies.
• Explains study processes, procedures, risks, and expectations to ensure informed consent and participant understanding.
• Assists participants with completing consent forms and documents per IRB and institutional requirements.

Study Coordination

• Schedules study participants for protocol-mandated tests, imaging, and procedures, including laboratory tests, x-rays, cardiology and ophthalmology assessments, and other specialty visits.
• Coordinates across multiple departments (e.g., Cardiology, Ophthalmology) to ensure smooth participant flow and adherence to SOPs and protocol timelines.
• Enters participant data into study databases and ensures timely, accurate documentation throughout the study.
• Communicates with investigators, study teams, and external departments to maintain study continuity.

Study Conduct

• Collects patient information and processes study-related documents.
• Performs or assists with venipuncture (blood draws), EKGs/ECGs, and obtains vital signs for study participants after completing required training.
• Collects, processes, ships, and maintains documentation for blood and biological specimens per protocol requirements.
• Ensures participant safety and protocol compliance during study visits and procedures.

Regulatory Assistance

• Maintain and update essential regulatory documents, including IRB submissions, consent forms, protocol documents, and training logs.
• Prepare and update source documents in alignment with eCRF requirements and study-specific EDC guidelines.
• Ensure regulatory files remain accurate, compliant, and audit-ready throughout the study lifecycle.
• Communicate with internal teams and external sponsors regarding regulatory documentation and required updates.
• Performs other job duties as assigned.

Study Start-Up Activities

• Take part in sponsor meetings and assist with study start-up planning and execution.
• Support the Team Lead with preparing site initiation materials, collecting required documents, and ensuring all operational components are in place for study launch.
• Organize study materials and assist with site readiness activities during the initiation phase.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Master's degree in a related field. 
• Industry -CRO sponsored studies and Oncology Trials.