CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
Screen participants independently and provide oversight and training to study team members who screen participants. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. 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.
Describe the various steps involved in handling IP. Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering 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 and provide training to others in these tasks. Assist with addressing and correcting findings from study monitoring and study audit visits.
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. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. 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. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis 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 and eCRFs) accurately and according to protocol. Use required processes, policies, and systems to ensure data security and provenance. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Assist with development of and follow SOPs for data quality assurance.
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including others with my title. Employ escalation and performance plans as needed. 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:
Collect information to determine appropriate feasibility, recruitment and retention strategies. 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 and closeout meetings independently Recognize components of operational plans and be able to obtain information needed to develop the plan. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities
Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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
Patient population involved heart and lung transplant patient in a randomized controlled protocol. There will be a variety of sample collections required and data collection. Not a lead but will coordinate efforts with other CRCs working on the same protocol.
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 in the Cardiothoracic patient population a definite benefit.
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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.