Covenant Health

Clinical Research Study Coordinator, Proton Therapy 

Full Time, 80 Hours Per Pay Period, Day Shift 

Position Summary: 

The Clinical Research Study Coordinator promotes good clinical practices in the conduct of oncology clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. In addition, the Clinical Research Study Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records, and maintains data and source documentation. The Clinical Research Study Coordinator performs all the duties and responsibilities associated with high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment, and oncology knowledge. Reports to the Clinical Trials Manager.

If you have any questions please contact Recruiter: Kimberlin Woods || 865-374-5403 || kwoods8@covhlth.com

• Participates in protocol planning by applying knowledge of patient population and anticipated recruitment; considering the ability to maintain the rights, safety, and well-being of the patient; and serving as the liaison between the investigator and the sponsor to clarify expectations, goals, procedures, questions, and concerns.
• Responsible for the setup, maintenance, and tracking of laboratory biospecimens for all oncology clinical trials according to the protocol requirements. Must maintain IATA certification to ship biospecimens. Retrieves, prepares, and ships biologic specimens; obtains dry ice for shipping specimens; and tracks/records research specimen freezer temperature daily to assure specimen integrity. Keeps up with lab kit inventory.
• Plans and implements pre-study activities by developing timelines for conducting the clinical trial protocol, attending and participating in investigator meetings at the manager’s discretion, and scheduling and coordinating pre-study site visits, initiation visits, and monitoring visits.
• Manages subject recruitment and enrollment of assigned protocols by monitoring enrollment goals and modifying recruitment plan as necessary, maintaining patient screening/enrollment logs, and reviewing information about the protocol including inclusion/exclusion criteria with investigator. Assures that all screening, eligibility, and enrollment procedures are performed according to protocol requirements by reviewing source documents in EMR. Attends multidisciplinary conferences to help physicians with questions regarding eligible trials for patients presented at conference.
• Maintains federal guidelines for informed consent process by communicating information about the protocol, Informed Consent Form, and follow-up procedures with potential study patients. Under the direction of the investigator, conducts interviews to assess the patient’s ability and willingness to follow and complete study procedures and visits, and obtains informed consent from the patient prior to any study-related procedures as outlined by GCP guidelines, documenting appropriately.
• Coordinates patient enrollment in clinical trial by following randomization procedures as per protocol; scheduling patient office visits and required screening assessments; ensuring appropriate specimen collection, batching, and shipping per protocol; and assessing participant compliance with the test article and follow-up visits.
• Manages clinical trials patients by scheduling all protocol required tests, physician and nurse assessment visits, monitoring patients’ response to protocol treatment, accompanying the physician for all protocol required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health System IRB according to protocol guidelines, and manages/resolves complex patient/physician/clinical trial issues without supervision.
• Ensures patient safety with ongoing patient education about cancer treatment and disease process. Performs subjective patient assessment and promptly reports all findings to investigator and sponsor. Recognizes laboratory values and assessment findings which are outside of normal limits.
• Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents (e.g., office notes, scans, tests, procedure results), abstracting data to study forms and flowsheets, recording accurate and timely data into electronic or hard copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to be used in protocol implementation and resolving data queries, and amending case report forms as appropriate.
• Maintains investigational agent accountability with proper utilization of drug logs and patient diaries, ensuring protocol guidelines are adhered to by all pharmacy staff. Provides oversight of storage and integration of clinical trial pharmacy protocol with Covenant Health site policy.
• Protects participant confidentiality by adhering to HIPAA regulations, protecting patient privacy at all times, securing safe storage of study-related documents, assuring appropriate disposal of PHI, and securely storing all archived files.
• Communicates effectively with patients, research team, IRB, sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishes a contact mechanism for participants regarding follow-up visits and new information, and encourages study participants to report study-related events to the research team immediately. Effectively communicates with investigator and sponsor representative to ensure protocol compliance. Punctually submits reports, suggestions, and concerns to manager.
• Participates in monitoring visits and audits by collecting source documents for sponsor/audit review; meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues; and preparing for and participating in FDA inspections as needed.
• Plans and directs site operations by assisting with the review and development of standard operating procedures manual and revising/updating procedures based upon regulations and guidance documents. Participates in the orientation and training of new research staff/ancillary staff involved in administering protocol treatments. Supervises Clinical Trial Associates.
• Implements quality controls and assurance measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, and working with internal and external quality assurance teams.
• Maintains professional and technical knowledge by attending NCI Cooperative Group meetings (at least annually) at the discretion of the manager, presenting professional education to colleagues, reviewing professional publications, and participating in professional societies. Completes all required IT training to access various electronic data capture systems and electronic medical records. Proficient with basic office software such as Microsoft Office.
• Local travel required.
• Follows policies, procedures, and safety standards. Completes required education assignments annually. Works toward achieving goals and objectives, and participates in quality improvement initiatives as requested.
• Performs other duties as assigned.

Minimum Education:

None specified; will accept any combination of formal education and/or prior work experience sufficient to demonstrate possession of the knowledge, skill, and ability needed to perform the essential tasks of the job, typically such as would be equivalent to an Associate’s degree. Preference may be given to individuals possessing an Associate’s or Bachelor’s degree in a directly-related field from an accredited college or university.

Minimum Experience:

Two (2) years of experience in a medical office, preferably oncology; and, two (2) years of experience in clinical trials. Excellent written and oral communication skills and project management skills. Good interpersonal and leadership skills. Excellent computer skills.

Licensure Requirement:

Employee must have a valid Tennessee driver’s license and state mandated minimum insurance coverage. Driving record must meet Covenant Health minimum standards at the date of hire and throughout employment tenure.

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