Sr Clinical Research Coordinator Phase I, Registered Nurse

Job Summary:
The Senior Clinical Research Coordinator for Phase I Clinical Trials is a health professional having an advanced working knowledge of data management activities with excellent communication skills. The position requires certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals. Also required is the use of advanced-level knowledge and skills to independently coordinate, direct and follow through in the overall administration and outcome of one or more early-stage clinical studies. This position will provide leadership for a department-wide clinical research program, including overseeing lower-level clinical research coordinators and/or other support personnel involved in testing and evaluation of investigational drugs and vaccines and clinical research studies involving specimen collection from human participants. Works directly with sponsors and investigators. Develops and maintains good clinical practice standards, staff development programs. Ensures compliance with organizational SOPs and government regulations for the conduct of research with human subjects.

Education:
Required:
Graduate of an accredited school of nursing. Master's degree in nursing or similar level of education.

Experience:
Required:
Prior experience as a Clinical Research Coordinator for clinical trial(s).
Minimum five (5) years of clinical trials research involving human subjects.
Minimum five (5) years of supervisory responsibility.
Minimum five (5) years of Ambulatory Nursing and/or Inpatient Nursing.
Certified Clinical Research Coordinator

Position Requirement(s): License/Certification/Registration
Required:
Current license to practice nursing in the State of Tennessee.
BLS completed prior to going to the unit/department and to be maintained going forward.

Department Position Summary:
The Senior Clinical Research Coordinator for Phase I Clinical Trials is a health professional having an advanced working knowledge of data management activities with excellent communication skills. The position requires certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals. Also required is the use of advanced-level knowledge and skills to independently coordinate, direct and follow through in the overall administration and outcome of one or more early-stage clinical studies. This position will provide leadership for a department-wide clinical research program, including overseeing lower-level clinical research coordinators and/or other support personnel involved in testing and evaluation of investigational drugs and vaccines and clinical research studies involving specimen collection from human participants. Works directly with sponsors and investigators. Develops and maintains good clinical practice standards, staff development programs. Ensures compliance with organizational SOPs and government regulations for the conduct of research with human subjects.

Essential Responsibilities:
Collaborates with principal investigators, study sponsors, trial monitors and establishing, implementing and conducting clinical research trials.
Supervises junior clinical research staff, assesses their needs, and identifies educational opportunities. Helps the Director of Clinical Operations in recruiting and hiring new clinical research staff. Develops training materials, monitors adherence to client education and training requirements, and takes responsibility for training new hires.

Performs as point person for decision-making and problem-solving day-to-day operation of projects, including the resolution of technical problems and questions of research staff, external monitors etc. within their assigned department.

Collaborates in the management of research data collection involving human participants. Implements quality assurance programs and develops strategies that improve the quality of research conducted and patient care. Recommends corrections, remediation and corrective/preventive action plans based on trending and reporting of monitoring or audit findings.

Assists in ensuring the delivery of high-quality care and service that meets defined standards and consistent compliance with the Nursing Practice Act, Guidelines for Good Clinical Practices, Federal, state and local regulations for the conduct of research. Provides an opportunity to learn daily and contribute to treatments of the future. Enthusiasm for learning required, along with participation in educating patients, physicians, nurses and other personnel to the research process. Advanced nursing position that involves clinical patient contact, research study coordination and study data management. Must be able to organize complex components of clinical trials, including test ordering, procedure scheduling for participants, if applicable.

Clinical skills that may be required include, but not limited to, patient assessment for adverse events and assistance with, or completion of, study related procedures as detailed in the research protocol (ex: injections, phlebotomy, or infusions), within the applicable state scope of practice.

Demonstrate a desire and ability to strictly adhere to all levels of institutional, state and federal regulations and established research protocols, and the ability to collaborate with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up.

Attend investigator meetings and coordinate pre-study site visits. Monitor enrollment goals and modify recruitment plan as needed. Ensure the completion of all screening, eligibility and enrollment procedures. Work with pharmacy to dispense study articles and provide subject education.

Clarify questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures. Review inclusion/exclusion criteria to assure subject eligibility and review with physician investigator. Review study protocol, informed consent form and follow-up procedures with potential study subjects.

Schedule subjects for follow-up visits to review diaries and questionnaires. Ensure appropriate specimen collection, batching and shipping as required. Document and maintain all study-related procedures, processes and events. Document protocol deviations, exemptions, and record accurate and timely data. Maintain accurate source documentation for all case report entries and input data for submission.

Required to use appropriate nursing assessment skills to evaluate patient condition in response to study intervention. Collect data regarding patient condition for review by the physician investigator.

Prepare case report forms and source documents for sponsor review. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets.

Communicate effectively with subjects, research team, Institutional Review Board (IRB) and sponsor representatives.