CLINICAL RESEARCH COORDINATOR

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

CLINICAL RESEARCH COORDINATOR
Phase 1 Clinical Research

This is a 100% sponsored funded position.

Occupational Summary

Participate in clinical research studies conducted by principal investigators (PIs) for the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the Phase I Team. Perform study-specific regulatory & safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), & study- specific protocols, plans and processes.

Work Preformed

Clinical Research Operations, Screen, schedule, consent, & 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.
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.

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. Track IP compliance at the protocol-and subject level.

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.).

Ethical & Participant Safety Considerations- Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research with vulnerable populations. 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 & 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.

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 & 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 & 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.

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.

Study & 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.

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 & 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.

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
401245422

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, 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.

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.

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


Auto req ID

88579BR

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.

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