CLINICAL RESEARCH COORDINATOR
CLINICAL RESEARCH COORDINATOR
DCI CANCER CONTROL (CPDC)
This is a 100% sponsored funded position.
Participate in clinical research studies conducted by principal investigators (PIs) for the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the Cancer Control and Population Sciences Team. Perform study-specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study- specific protocols, plans and processes.
Clinical Research Operations- Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol- specific testing or interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. 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.
Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling.
Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.
Develop or provide input for Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level.
Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports.
. 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.).
Ethical and Participant Safety Considerations- Maintain familiarity 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. Train junior staff in the ethical conduct of research, dealing with vulnerable populations, and provide guidance in strategies used to maintain safety. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
Data Management and Informatics- Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. 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. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions.
Investigate incomplete, inaccurate, or missing data and documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data.
Use required processes, policies, and systems to ensure data security and data provenance. 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.
Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised.
Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions (IDEs), etc.).
Scientific concepts and research design- Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify shortcomings of proposals and protocols.
Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
Leadership and Professionalism- Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead a committee, task force, or ad hoc group. Encourage career development by actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications.
Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other Clinical Research Coordinators. Employ escalation and performance plans as needed.
Study and site management- Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, 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. Assist with study budgets.
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.
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.
Communication and Team Science- Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members.
And other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
1201 CLINICAL RESEARCH COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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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.
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.
The preferred candidate will have oncology or research experience, training, education.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Good communication skills - consenting patients, administering questionnaires, interacting with multiple disease groups and the Duke Biorepository; detail oriented; good computer skills (EMR navigation, data management); familiarity with regulatory submissions; ability to work with specimens (blood); good critical thinking skills - proactive and strong ability to multitask.
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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.