CLINICAL RESEARCH COORDINATOR
- Location: Durham, NC
- Posted: Oct 8, 2019
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nations top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Develop, coordinate and manage clinical research studies conducted by Duke Principal Investigators within the department of OBGYN, division of Urogynecology. Lead coordinator for the Lower Urinary Tract Dysfunction Network (LURN) at Duke.
1. Screen participants independently and provide oversight and training to study team members who screen LURN participants. Demonstrate understanding of LURN protocols and translate into project logistics. Will serve as the primary liaison for the LURN Network and its subcontractor (s), or vendors and lead LURN team meetings.
2. Maintain subject level documentation for all studies independently. Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
May assist with management of investigational product (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.
3. 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. Independently conducts and documents consent for participants in all studies, including those that are complex in nature/clinically relevant and/or require access to the EHR for documentation.
4. Provide direction to study teams with preparation for LURN study monitoring or study audit visits. Address and correct audit/monitor findings. Collect, prepare or process adverse event information independently Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
5. Develop LURN DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
6. Attend LURN Network conferences, meetings, site initiation visits and monitoring visits.
7. May participate in LURN scientific presentations and publications.
8. Maintain LURN specific training requirements and develop solutions to proactively ensure study team members' compliance with these training requirements.
9. 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.
10. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
11. Assist with the coordination of efforts of external monitoring boards.
12. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.
13.Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
1. Use EDC systems and enter data accurately and train others in these tasks. Detect issues related to data capture, collection or management and suggest solutions. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data.
2. Assist with development of and follow SOPs for data quality assurance. Recognize when data agreements are necessary.
1. Identify various LURN stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
2. May assist with development of research proposals or protocols.
Study and Site Management:
1. Determine and implement alternative solutions to accomplishing LURN recruitment and retention milestones.
2. Ensure participant care expenses have appropriate financial routing in a timely manner. May monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in LURN budget development as appropriate. Assist with LURN study budgets.
3. 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.).
4. Oversee maintenance of LURN Delegation of Authority Logs and training of key personnel on study specific duties.
5. Take part in site initiation and closeout meetings independently. Assist with the development of LURN protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Prepare for closeout and document storage.
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.
Phlebotomy experience preferred.
Human subject clinical research experience preferred.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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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.