CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
DCI CANCER CONTROL (CPDC)
Develop, coordinate, and supervise research and administrative activities of clinical research studies conducted by principal investigators (PIs) for the Cancer Control and Population Sciences (CCPS) Program. Develop and oversee a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data and specimen submission. Coordinate and perform study specific regulatory processes across multiple studies, in accordance to appropriate regulations, Standard Operating Procedures (SOPs) and study specific protocols/projects and processes.
You will build and maintain a close, collaborative working relationship with the CCPS study team, including: PIs, investigators, nurses, data and regulatory coordinators, and other clinical research staff to effectively manage research studies within the CCPS, the Duke Cancer Institute (DCI), Oncology CRU administrative team and the oncology department staff. You will build and maintain effective relationships with key study personnel, clinical resources and regulatory colleagues within the Oncology CRU.
This position serves as a member of the CCPS and ensures protocol compliance by using independent critical thinking skills to: screen and consent participants in clinical research studies, confirm eligibility criteria, administer Quality of Life Questionnaires, ensure protocol required specimen collections occur, ensure protocol compliance and proper adverse event/deviation documentation, and fully manage IRB submissions and communications. This position may also serve as an expert to train more junior members of the team, participates in new study start-up efforts, uses problem-solving skills to assess clinical, logistical, financial and regulatory issues, and participates in monitoring and auditing activities.
Provide protocol specific service to patients within the age group 18-65 and over.
Ongoing training of lower level coordinators as needed.
Confer with PIs in developing plans and protocols for clinical research studies, discuss the interpretation of results and prepare of manuscripts for publication.
Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.
Complete the informed consent process with patients, ensure eligibility requirements are met and follow protocol guidelines for non-chemotherapy clinical trials.
Screen patients for inclusion in non-chemotherapy studies based on pre-determined criteria and register patients as appropriate.
Perform QI processes consistent with Oncology CRU initiatives, including review of participant consent forms for correct completion with proper documentation. Report any deviations to the study team.
Enter MaestroCare information at the time of enrollment, linking the patient to the RSH record, study encounter and timeline PRIOR to close of the study encounter.
Maintain current enrollment logs on all consented studies.
Monitor and ensure all consented patients are entered into the Clinical Research Management System (CRMS) .
Assist PIs, the RPM, the ARPM, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
Ensure specimen submissions for research protocol participants.
Evaluate sponsor data capture design and software and provide constructive assessment information when applicable.
Provide routine updates and reporting to the study team to ensure timely communication regarding status of regulatory and safety related issues.
Regulatory and Data Management,
Obtain required signatures on all regulatory documents.
Complete HIPAA waiver, consent form, research summary, Cancer Protocol Committee (CPC) study form, pathology form and radiology form from the eIRB website.
Prepare and process all regulatory documentation through the Institutional Review Board (IRB) and other entities as required.
Communicate and collaborate with appropriate departments for study start-up and IRB approval. (Radiology, pathology, OCRC, finance).
Notify study team of all approved amendments as appropriate and maintain study team training documentation.
Maintain file of CVs, medical licensure, conflict of interest, lab certifications, notes to file, and other documents as needed in regulatory binders.
Monitor and ensure all actively enrolling studies are published on the DCI website and promptly remove studies not actively enrolling from the DCI website.
Provide information as needed to ensure timely resolution of regulatory related queries with the IRB, study sponsors, and CROs.
Submit accurate and timely data submission for clinical research studies; Minimize and respond to sponsor generated queries and delinquency lists in an accurate and timely manner.
Management of shadow charts of for research participants.
Monitoring and Audits,
Schedule and coordinate internal and external monitoring visits and audits, ensure regulatory and data documents are updated and available for monitors/auditors, greet monitors/auditors, and assist as needed with questions.
Review and respond to monitor/audit reports; Develop and implement corrective action in a timely manner when problems in research practice are identified.
All other duties as assigned.
The above statements describe the general nature and level of work being performed.
This is not intended to be an exhaustive list of all responsibilities and duties required.
The intent of this position description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
You may be directed to perform job-related tasks other than those specifically presented in this description.
Attend required clinical research, Clinical Research Coordinator (CRC), departmental staff meetings, study-star-up meetings, DOCR training sessions, and CCPS Program Meetings.
Participate in and complete designated and/or required training [Clinical Research Unit (CRU), Human Subject Research (HSR), CITI modules, MaestroCare, Beacon, IRB, etc.]
Effectively manage your workload, seeking help whenever it's needed.
Communicate frequently with your manager, keeping them up-to-date on your work and issues as they arise. You will work closely with your manager to implement departmental & Duke Policy and initiatives.
Adherence to core work hours; time off requests will be submitted to your manager per departmental & Duke Policy. Patient care is our primary mission. When the unexpected happens you may be called upon to provide coverage outside your core work hours.
Know and comply with the regulations, rules and Standard Operating Procedures for your department, Duke Medical Center, School of Medicine, OncCRU and the Duke Office of Clinical Research.
Comply with Duke's rules, regulations and responsibilities as noted in The Duke Employee Handbook and on the Duke HR website.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
1.Completion of a Bachelor's degree. 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).
Experience with consenting patients to clinical research studies required.
Communication - Excellent written and oral communications skills, including telephone, email, and face-to-face communication.
Computer - Mastery of Microsoft Office, especially Word and Excel, multiple electronic databases and computer based information systems.
Organization - Ability to organize and prioritize across multiple studies.
Critical Thinking and Problem Solving - Self-directed ability to analyze and assess a situation for problems and develop an acceptable solution
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.