Clinical Research Coordinator
Screen participants for all studies independently.
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.
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.
Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.
Oversee maintenance of subject level documentation.
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.
Provide direction to study teams with preparation for 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.
Have familiarity with intellectual property rights, inventions patents, and technologies.
As appropriate, understand regulations related to investigational products with sponsors.
Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc.
Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications.
Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
Assist with the coordination of efforts of external monitoring boards.
Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial
Map protocol data flow.
Predict areas of vulnerability for a protocol's data flow plan.
Determine areas where data provenance may be compromised.
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.
Recognize and report vulnerabilities related to security of physical and electronic data.
Suggest and implement solutions to vulnerabilities related to security of data and data provenance
Independently investigate incomplete,inaccurate or missing data/documents to ensure accuracy and completeness of data.
Run summaries and reports on existing data
Assist with development of and follow SOPs for data quality assurance.
Recognize when data agreements are necessary
Conduct literature reviews independently
Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
Assist with development of research proposals or protocols.
Encourage and support colleagues in completing project work.
Assist research colleagues in identifying efficiencies and improving process.
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 training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.
Study and Site Management:
Determine and implement alternative solutions to accomplishing recruitment and retention milestones.
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:
Portfolio Management (Effort %): Clinical responsibilities:
• Other: Type of Research This Gastroenterology CRC will be responsible for identifying eligible study participants, providing informed consent, collecting data, performing study visits, in compliance with sponsor, regulatory, and institutional guidelines. Study types include industry, federal, and investigator initiated.
In addition to recruiting within GI and endoscopy clinics, this position will liaise with other clinics to maximize subject recruitment. This position will report directly to the CRC, Sr.
Candidate will possess exquisite communication skills, ability to work in teams, as well as perform autonomously.
Candidate will have basic computer knowledge, including MSOffice and calendaring.
Previous research experience preferred, but not required. ACRP or SOCRA certification suggested at earliest eligibility.
Requisition Number 401500885
Duke Entity MEDICAL CENTER
Job Code 1201 CLINICAL RESEARCH COORDINATOR
Job Family Level 52
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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1.Completion of a Bachelor's degree 2.Completion of an Associates degree plus a minimum of two yearsrelevant experience (e.g., research, clinical, interaction with study population, program coordination)
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