Clinical Research Coordinator
Heme Clinical Rsch
Coordinate and participate in multiple retrospective, Phase 1, Phase 2, and potentially multisite Phase 3 clinical trials for the Duke Cancer Institute’s (DCI) Oncology Clinical Research Unit (OncCRU) for the Hematology Malignancies and Bone Marrow Transplant Clinical Research Programs including corporate sponsored clinical trials.
Responsibilities and Expectations
Operations – 50% Effort
- Screen participants independently and provide oversight and training to study team members who screen participants. Maintain subject level documentation for all studies independently, including in the Electronic Medical Record (EMR). Schedule participants and conduct visits for all studies independently. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
- Improve systems related to specimen handling. Collect, prepare, process, ship, and maintain inventory of research specimens.
- Implement innovative solutions to maximize recruitment and retention. Conduct and document consent for participants in a variety of studies independently.
- Schedule and prepare for study monitoring or study audit visits. Address and correct audit and monitor findings.
- Oversee the collection of adverse event information. Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
- Follow study payment procedures and document in timely fashion. 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.
Ethics – 5% Effort
- Articulate, to study staff and research participants, the reasoning for an individual protocol's inclusion and exclusion criteria.
- Recognize and assist when patients are having difficulties with this distinction.
- Make recommendations regarding how to improve communications to help patients and staff understand the distinction.
Data – 25% Effort
- Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Use Electronic Data Capture (EDC) systems and enter data accurately and timely.
- Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions. Investigate issues related to accuracy and completeness of data. Recognize trends related to data quality and escalate as appropriate. Monitor QA of study data. Detect issues related to data capture, collection or management and suggest solutions.
- Independently design ECRFs and EDCs to collect data according to protocol. Develop and run queries and reports. Develop and follow SOPs for data QA.
Science – 5% Effort
- Collaborate with stakeholders to ensure adequate design, implementation and testing of study aims. Develop research proposals or protocols with little assistance. Identify operational shortcomings of proposals and protocols. Summarize study results.
Leadership – 5% Effort
- Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Lead study teams with regard to clinical research professional guidelines and code of ethics. Encourage career development by actively seeking out continuing education opportunities for self and study team members.
Maintain training requirements.
- Identify potential problems and risks to the participant, study, investigator, team, sponsor, and institution. Employ escalation and performance plans as needed.
- Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
- Mentor, train and provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies.
Study and Site Management –5% Effort
Make recommendations to investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies.
Take part in site initiation and closeout meetings independently. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Coordinate operational plans for multiple research studies. 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 – 5% Effort
- Take action when communication has stalled with sites, CROs, sponsors. Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.
- Build and maintain effective relationships with key study personnel, clinical resources and colleagues throughout the institution.
Basic Life Support (BLS) or equivalent Duke approved course is required for this position.
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.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
The preferred candidate will have oncology or clinical research experience.
Requisition Number 401499192
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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- Completion of a Bachelor's degree
- Completion of an Associates degree plus a minimum of two yearsrelevant experience (e.g., research, clinical, interaction with studypopulation, program coordination)
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