Clinical Research Coordinator III (RN)

American Oncology Network • Houston, TX

1d

About The Position

The Clinical Research Coordinator is an integral member of the Research Team at Oncology Consultants and participates in multiple aspects of clinical trial management under the general supervision of the Clinical Research Manager and the Research Director. The role supports study feasibility and start-up, regulatory submissions, site initiation, patient recruitment and enrollment, clinical trial coordination and patient care, study data and documentation management, monitoring and audit activities, and research department operations.

The coordinator helps ensure that research activities comply with study protocols, regulatory requirements, and institutional policies. The position involves communicating with patients, investigators, IRBs, sponsors, and research team members; coordinating study visits and clinical procedures; maintaining study records and case report forms; and providing operational and administrative support to the research department.

Requirements

• Degree in life sciences or health sciences, such as Registered Nurse (R.N.), Doctor of Philosophy (Ph.D.), Medical Doctorate (M.D.), or another related degree.
• Two or more years of clinical research experience.
• Strong verbal and written communication skills.
• Annual completion of the NIH Protection of Human Subjects online course is required.
• IATA training is required every two years.

Nice To Haves

• Research certification through a recognized national organization such as SOCRA or ACRP is encouraged.

Responsibilities

• Support study feasibility, regulatory submissions, and study initiation activities.
• Apply knowledge of study design to evaluate protocol feasibility at the site.
• Assist Regulatory staff with preparing and submitting documents to the Institutional Review Board (IRB).
• Participate in study site initiation activities and attend investigator meetings and clinical trial conferences as directed.
• Document protocol deviations and exemptions.
• Prepare for and participate in FDA inspections.
• Communicate with IRBs, sponsors, investigators, and research team members.
• Participate in patient recruitment and evaluate patient eligibility.
• Review and verify source documents and inclusion and exclusion criteria to confirm study eligibility.
• Interview potential study subjects to assess their ability and willingness to complete study procedures.
• Maintain patient screening and enrollment logs.
• Explain protocol requirements, informed consent, and follow-up procedures to potential study subjects.
• Follow study randomization procedures and provide patient-centered communication and customer service.
• Coordinate study visits and perform clinical procedures while ensuring protocol compliance.
• Ensure study drugs are dispensed according to protocol, maintain drug accountability records, and review and document returned drugs.
• Provide direct care related to study compliance throughout the research experience.
• Perform peripheral venipuncture according to organizational standards.
• Collect, batch, process, and ship specimens according to protocol; collaborate with site staff on specimen processing.
• Obtain test results and report them to the physician investigator.
• Attend clinic visits with the investigator and assist with following study guidelines.
• Obtain and review original source documents, including recordings, scans, test results, and procedure reports.
• Abstract data from medical records and other documentation to study forms and flow sheets.
• Complete and maintain study documentation and case report forms, and resolve data queries.
• Schedule sponsor monitoring visits and prepare case report forms and source documents for sponsor and audit review.
• Assist with audit preparation and monitoring visits.
• Participate in educational and training activities and continuing education.
• Support management team projects and assist with maintaining budgetary data for each clinical trial.
• Assist with planning department coverage for clinic visits, data management, and meetings.
• Maintain professional communication with internal and external customers.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level