Clinical Research Coordinator

This is a clinical research coordinator position that participates as a member of a multi-disciplinary team in the planning and implementation of treatment and follow-up care for patients with oncologic diseases that are enrolled on radiation therapy research protocols. This position is also responsible for data management related to the treatment and clinical follow-up of these patients.

This individual provides support to the COMPPARE Study located at the University of Florida Health Proton Therapy Institute in Jacksonville.

Job Description:

• Identify Potential Candidates For Entry on COMPPARE

a. Educate clinical staff regarding COMPPARE eligibility requirements.

b. Review consultation and re-evaluation charts prior to patient visit for igibility.

c. Notify clinical staff about potential eligibility for enrollment prior to evaluation and follow-up after evaluation.

Eligibility

a. Prescreening of patients for eligibility on the study

b. Verify eligibility for upcoming registrations

c. Resolve queries for review and feedback.

Manage Study Related Patient documentation

a. Enter accurate protocol, study, treatment, and patient information into VTOC, other databases as required

b. Submit accurate and complete data according to protocol timelines.

c. Maintain complete case report forms and/or research charts in compliance with privacy laws.

d. Collaborate with investigators and monitors to resolve discrepancies or queries in case report forms.

Entry of data in multiple PCORI COMPPARE study databases.

a. This individual will maintain the study database for Adverse Events, Deaths, Progressive Disease and Treatment Failures. They will also be responsible for the data acquisition, inputting, updating, investigating and reporting on data related to radiation treatment, protocol deviations, disease site/histology, second primaries, demographics, treatment failures, and deviations.

b. This individual will process and maintain the Delegation of Responsibility logs for site. The DOR will identify individuals who will make significant contributions to the conduct of the study and verify they are qualified to perform study related functions.

c. They will also ensure that appropriate standardized training documentation is maintained for the study.

d. Process and maintain all adverse events (AE)/deviation logs. This individual is responsible for reporting the details of the AE to the Sponsor and their IRB, as applicable, as required by established policies and procedures. This individual will also report the details of any deviations to University of Florida.

Manage IRB submissions

a. Responsible for submission of regulatory documentation for IRB approval on a timely basis to meet ongoing expiration dates.

b. Attend IRB meetings as necessary.

Preferred Qualifications:

Certification in Clinical Research Coordination preferred.

Other Characteristics of the Position

• Ability to interpret and apply grant & contract guidelines and regulations

• Knowledge of IRB processes

• Ability to obtain patient samples, including blood draws, preferred

• Skills in word processing and spreadsheet programs, including Microsoft Excel, database programs, including Access, email, including Outlook, and Web browsers

• Ability to collect and evaluate data relative to clinical trials and research

• Ability to work independently, plan, organize, and coordinate work assignments

• Ability to understand and apply applicable rules, regulations, policies, and procedures

• Ability to learn new software

Policy making and/or interpretation.

Responsible for interpretation of the various clinical trial guidelines and protocols. Responsible for development of department/clinic policies and procedures related to accrual and follow-up of patients on clinical trials.

Program direction and development.

Responsible for direction of clinical trials and protocols.

Communication

Interaction with clinical staff (physicians, nurses, therapists) relating to clinical trials and protocols on a daily basis, as needed.

Monetary responsibility

Responsible for compliance with clinical trials accrual, reporting and protocol guidelines. Failure to comply with requirements could result in forfeiture of funding support for the clinical trials, and loss of ability to participate in the study group.

Statement of responsibility for confidential data.

Employee is privy to confidential patient files and research data of the department. Must comply with all Federal, state and institutional rules and regulations governing confidential information.

Normal work schedule

Monday through Friday – 8 AM to 5 PM and occasional hours before or after as needed.

EDUCATION, TRAINING, AND EXPERIENCE

Minimum Qualifications:

Bachelor’s degree in an appropriate area of specialization

Preferred Qualifications:

Certification in Clinical Research Coordination preferred.

HOW TO APPLY:

Application form

Supplemental Employment Application Questionnaire

Voluntary Self-Identification of Disability form

To apply for employment with the Hampton University Proton Therapy Institute, send your completed application form and current resume to:

Human Resources
Hampton University Proton Therapy Institute
40 Enterprise Parkway
Hampton, VA 23666

You can also email your application materials to: hr@hamptonproton.org