CLINICAL RESEARCH NURSE COORDINATOR

Location
Durham, NC
Posted
Jun 14, 2018
Institution Type
Four-Year Institution

diversity employer



CLINICAL RESEARCH NURSE COORDINATOR
Medicine-Infectious Diseases

Operations:

Screen participants for all studies independently. May 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 and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews.

Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.

May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level.

Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Implement innovative solutions to maximize recruitment and retention 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.). Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.

Ethics:

Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. 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. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.

Data:

Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. 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. Use required processes, policies, and systems to ensure data security and provenance.

Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data.

Follow SOPs for data QA. Recognize when data agreements are necessary.

Science:

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. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.

Study and Site Management:

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. Assist with study budgets. 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. Take part in site initiation and closeout meetings independently.

Assist with the development of 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. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.

Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Description of Portfolio and Clinical Responsibilities:

Portfolio Management: Clinical responsibilities:

• Ambulatory Medication Administration

• Adult Medication

• Alaris Pump Set up and Use

• Other: Type of Research.

This position is with the Infectious Diseases Division within the Department of Medicine.

The majority of trials for this position will be industry sponsored dealing with subjects that are being treated for fungal infections.

This position will be part of a shared weekend call coverage system for the group and could have some off-hour work time.

Special Skills

A nurse with oncology trial experience is preferred due to the nature of the clinical trials assigned to this position.

Requisition Number
401376382

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1203 CLINICAL RESEARCH NURSE COORDINATOR

Job Family Level
54

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

Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor's degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required.

Experience

Twelve months of appropriate clinical nursing experience is required.

Special Skills

A nurse with oncology trial experience is preferred due to the nature of the clinical trials assigned to this position.

Auto req ID

97083BR

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.

PI102926463

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