CLINICAL RESEARCH COORDINATOR - SCHOOL OF NURSING

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

CLINICAL RESEARCH COORDINATOR - SCHOOL OF NURSING
SON-FACULTY AND STAFF


This position will be working with preventative care research involving nursing home patients and staff. The multi-AIMS study is focusing on the reduction of pressure ulcers, the cost metrics involved in the implantation of care and medical condition severity impacting the ulcers. The position requires frequent interaction with the PI, team members as well as subjects and nursing home staff.

Operations:

Screen participants for minimal risk studies.
Maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Schedule participants for study visits. Prepare necessary documents, equipment, supplies, etc.
Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies under direction. Follow procedures and documentation of study payment.
Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
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 Assist with addressing and correcting findings from study monitoring and study audit visits. 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.

Ethics:

Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. Be familiar 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. 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

Data:

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. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)

Science:

Conduct literature reviews under the direction of the CRC, CRNC, or PI Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.

Leadership:

Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group.
Encourage career development by actively seeking out continuing education opportunities for self and study team members.
Participate in scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including others with my title.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
Maintain Duke and project specific training requirements.
Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.

Study and Site Management:

Make recommendations to investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies.
Ensure participant care expenses have appropriate financial routing in a timely manner.
Maintain study's compliance with institutional requirements and other policies (e.g., NIHPublic 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

Communication:

Serve as primary liaison with single sponsor, subcontractor, or vendors.
Communicate concerns clearly and in a professional manner.
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. Take an active role in including others in decision-making.
Must be able to easily use computing software and web-based applications.

Requisition Number
401242623

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)

Auto req ID

88240BR

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.

PI97510054