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CLINICAL RESEARCH COORDINATOR

Job description


diversity employer



CLINICAL RESEARCH COORDINATOR
Brain Tumor Clinical Rsch


OCCUPATIONAL SUMMARY

Participate in human subject clinical research studies conducted by principal investigators (PIs) of the Brain Tumor Clinical Research Program (BTC). The studies are overseen by the Oncology Clinical Research Unit (OncCRU) within the Duke Cancer Institute (DCI). 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.

WORK PREFORMED

Clinical Research Operations - Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation. Conduct and document visits, testing, and interviews according to study protocol, operational plans of clinical departments, and SOPs for all types of studies independently.

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 (IRB) documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation.

Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction. 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.

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.

Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications.

Data Management and Informatics - Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations to accurately enter data. Score tests and measures according to protocol. Complete paper and electronic Case Report Forms (CRFs and eCRFs)

accurately and according to protocol. 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. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. Recognize and report vulnerabilities related to security of physical and electronic data, suggest and implement solutions.

Leadership and Professionalism - Encourage and support colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Encourage career development by actively seek out continuing education opportunities for self.

Mentor junior staff, including other Clinical Research Coordinators.

Study and Site Management - Participate in sponsor-required training. 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. 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. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.

Communication and Team Science - Communicate professionally, efficiently, and effectively amongst coworkers. Recognize when others need to be brought into discussions 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.

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.



Requisition Number
401503581

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1201 CLINICAL RESEARCH COORDINATOR

Job Family Level
52

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging.

Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

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.

Education

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).

Preferences

The preferred candidate will have oncology or research experience, training, education or prior Clinical Trials Coordination experience.

Skills

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).


Auto req ID

105764BR

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.

PI104858950

 

 

 

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Job No:
Posted: 10/12/2018
Application Due: 12/11/2018
Work Type:
Salary: