CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Medicine - Gastroenterology
- Screen participants for minimal risk studies.
- May screen participants for studies with greater than minimal risk, under supervision.
- Maintain subject level documentation for all studies independently
- Schedule participants and conduct visits for minimal risk studies independently.
- Improve systems related to specimen handling.
- May collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
- Assist with management of IP.
- Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.
- May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
- Maintain appropriate documentation.
- Track IP compliance at the protocol-and subject level.
- Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
- Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
- Evaluate processes to identify issues related to recruitment and retention rates.
- Conduct and document consent for participants in a variety of studies independently
- Assist with addressing and correcting findings from study monitoring and study audit visits.
- Collect, prepare or process adverse event information independently
- Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision.
- Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications.
- Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.
- Understand that the safety of research participants is a priority.Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial
- Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.
- Enter data accurately. Score tests and measures according to protocol, and appropriate to role.
- Complete paper and electronic Case Report Forms (CRFs andeCRFs) accurately and according to protocol.
- Use required processes,policies, and systems to ensure data security and provenance.
- Recognize and report vulnerabilities related to security of physical and electronic data.
- Assist in investigating incomplete,inaccurate or missing data/documents to ensure accuracy and completeness of data.
- Follow SOPs for data QA.
- May serve as mentor to other staff.
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
- Maintain Duke and project specific training requirements.
Study and Site Management:
- Ensure participant care expenses have appropriate financial routing in a timely manner.
- Monitor financial study milestones and report appropriately.
- Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate.
- Assist with study budgets.
- Maintain study's compliance with institutional requirements and other policies (e.g.,NIH Public Access policy,ct.gov, Research Data Security Plans, Social Media policy, etc.).
- Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
- Take part in site initiation/closeout visits as directed.
- Prepare for closeout and document storage
- Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
- Participate in study team meetings.
- Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.
- Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Description of Portfolio and Clinical Responsibilities
Type of Research The incumbent will enroll subjects into NASH clinical trials. She/he will ensure participants retention in the study while monitoring their compliance with study schedules and other tasks. Our studies target adults with NAFLD at various and we work with a variety of sponsors. the incumbent may thus have more than one sponsor to work with.
No specific skill is required if education criteria is met.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual'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 mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
1.Completion of a Bachelor's degree2.Completion of an Associates degree plus a minimum of two yearsrelevant experience (e.g., research, clinical, interaction with studypopulation, program coordination)
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.