CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
General Internal Medicine
Participate in and lead day-to-day operations of research projects conducted by the Chief of Duke General Internal Medicine (GIM) and other research faculty; perform variety of duties involved in developing, administering, coordinating, managing and monitoring all aspects of research projects including, but not limited to:
- Research Operations
Develop/provide input for Institutional Review Board (IRB) documents such as consent forms, protocols, continuing reviews, etc.
Develop/provide input for research proposals, progress reports, budgets and other related documents required by funding agency or institution according to protocol.
Maintain appropriate study-level documentation including regulatory binders, study enrollment, patient registration, etc. in the system of record.
Assist with hiring, training, supervising, monitoring and evaluating study staff involved in planning, implementation and evaluation of studies. Supervise and provide guidance to study staff, monitor workload, timeliness and accuracy of work, and assure compliance with human resources and human research ethics policies/procedures.
Screen, schedule, consent and collect research data and adverse event information for participants. Maintain subject level documentation, including documentation of verbal/written consent in the appropriate record (i.e. electronic medical record, REDCap, written consent form, etc.).
Collect/prepare/process adverse event information per protocol, and provide input for adverse event reports. Identify problems and/or inconsistencies and monitor research participants' progress to include documentation and reporting of adverse events to institution and sponsor-specific prompt reporting requirements; report to supervisor/principal investigator(s) and recommend corrective action as appropriate in a timely manner.
- Data Management/Informatics
Assist with development of data collection documents, such as forms, questionnaires, and interventions, to standardize process. Coordinate/implement procedures to collect data from these sources as well as from patient charts, medical records, tests and other sources. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Assist with development of SOPs for data quality assurance. Create procedures manuals for data collection, interventions and other research activities.
Confer with professional staff involved in data collection, analysis, and execution of studies to ensure compliance with protocol guidelines and adherence to requirements of institutional and funding agencies; identify problems and take action as appropriate.
Coordinate the gathering of data safety monitoring boards and other relevant groups.
Review and interpret data in conjunction with principal investigator(s), statisticians and other research team members; assist with preparation of presentations and written reports; collaborate on preparation of manuscripts.
- Scientific Concepts/Research Design
Study and site management:
Participate in sponsor-required training. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and case report forms. 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. Prepare for, take part in, and potentially lead site initiation, monitoring, and closeout visits and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. May make recommendations to investigators and oversight organization(s).
Develop budgets oversee post-award financial management of funded research.
Negotiate with and engage subcontractors relevant to research activities and oversee work to achieve desired outcomes.
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.
Engage community partners in research, including developing and fostering relationships with partners, and facilitating their participation on advisory panels and in research teams.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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).
Successful candidates will have:
- Advanced degree in epidemiology, public health, or related field
- Five or more years' experience implementing and overseeing intervention and/or health services or clinical research projects as well as managing/supervising studies and teams
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 identity, national origin, race, religion, sexual orientation, or veteran status.
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.