Clinical Research Coordinator III (RN)

American Oncology Network•Houston, TX

1d•$43,680 - $73,920

About The Position

The Clinical Research Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants. Under the general supervision of the Clinical Research Manager and the Research Director, the coordinator supports multiple aspects of the research process, including study start-up and regulatory activities, patient recruitment and enrollment, clinical trial coordination and patient care, data management, documentation, monitoring support, and research program administration. The role is based at Oncology Consultants - Memorial City, with 0–25% travel.

Requirements

A 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.
At least 2 years of clinical research experience.
Annual completion of the NIH Protection of Human Subjects online course is required.
IATA training is required every 2 years.
Strong verbal and written communication skills.

Nice To Haves

Research certification through a recognized national organization such as SOCRA or ACRP is encouraged.
Continuing education participation is expected.

Responsibilities

Support study feasibility, regulatory submissions, and study initiation activities in compliance with protocols, regulatory requirements, and institutional policies.
Evaluate protocol feasibility at the site; assist with preparing and submitting documents to the Institutional Review Board; participate in site initiation activities, investigator meetings, and clinical trial conferences as directed.
Document protocol deviations and exemptions, prepare for and participate in FDA inspections, and communicate with IRBs, sponsors, investigators, and research team members.
Recruit and evaluate patients, verify eligibility and source documents, review inclusion and exclusion criteria with the investigator, and assess patients’ ability and willingness to complete study procedures.
Maintain patient screening and enrollment logs; explain protocol requirements, informed consent, and follow-up procedures to potential participants; and follow protocol randomization procedures.
Coordinate study visits and clinical procedures while ensuring protocol compliance and patient-centered communication.
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, perform peripheral venipuncture, and ensure proper specimen collection, batching, processing, and shipping.
Collaborate with site staff to process specimens, prepare and ship study-required specimens according to the protocol manual, obtain test results, and report them to the physician investigator.
Attend clinic visits with the investigator and assist in following study guidelines.
Obtain and review original source documents, abstract data from medical records and other documentation to study forms and flow sheets, and complete and maintain study documentation and case report forms.
Resolve data queries, schedule sponsor monitoring visits, prepare case report forms and source documents for sponsor and audit review, and assist with audit preparation and monitoring visits.
Participate in educational and training activities and continuing education; support management team projects; and assist with maintaining clinical trial budget data.
Assist in planning department coverage for clinic visits, data management, and meetings, and maintain professional communication with internal and external customers.