Summary

Position manages and coordinates all activities of clinical trial research studies for the BCM Breast Oncology/ Dan L Duncan Comprehensive Cancer Center (DLDCCC). Primary responsibilities include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor. The Research Coordinator III will be responsible for ensuring accurate data collection, documentation, organization, and safety of study participants. Clinically and administratively manage multiple studies involving high volume of patients/participants in complex clinical trials.

Job Duties

• Coordinates and manages all clinical research activities including interviewing, screening, and recruiting patients for study; explains process and procedures to educate participant regarding the research study. Conducts or participates in the informed consent process including interactions with the (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Maintains complex records and regulatory documents and records for research studies. Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Works with the PI/Sponsors to develop and implement recruitment strategies in accordance with institution/IRB requirements and approvals.
• Attends investigator/Consortium meetings as required or requested by PI.
• Schedules and coordinates research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol.
• Collects patient information; processes documents and enters information into a database. May perform Venipuncture (blood draws), EKGs/ECG’s, study related assessments, and obtain vital signs on study participants.
• Collects, processes, ships, and maintains all documentation for blood and/or biological specimens according to procedures outlined in study protocol/lab manuals. Retrieves and submits test results to appropriate party.
• Comprehensive assessment of adverse events in collaboration with the participant's physician, as well as other care team members in accordance with the standardized NCI guidelines. Manages adverse events reporting to the appropriate party (sponsor/CRO/FDA/IRB). The research coordinator must have an understanding of which adverse events require modifications (e.g. dose delays, dose modifications, supportive care, etc.), and adequately communicate this to the treating physician and/or care team.
• Serves as study liaison between medical staff, physicians, sponsors, CRO/CRAs.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or institutional policy on Investigational Drug/Device Accountability.
• Other job duties as assigned.
  

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree in a related field.
• Four to five years of relevant experience.
• Certification/Licenses/Registration: ACRP/SOCRA.