CLINICAL RESEARCH SPECIALIST, SR

Duke University

United States

July 17, 2021

Description

CLINICAL RESEARCH SPECIALIST, SR

Requisition Number:: 128148

Date: Jun 16, 2021

Location:

Durham, NC, US, 27710

Personnel Area: MEDICAL CENTER

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Duke's Department of Obstetrics and Gynecology has an immediate need for a part-time Sr. Clinical Research Specialist working with minimal risk studies. (less than 20 hours)

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar Clinical Research Units (CRU)/Oversight Organization (OO) designee. Participate in day-to- day operations related to the collection, compilation, and documentation of clinical research data and may train Clinical Research Specialists (CRS) in these tasks.

Operations:

- Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

- Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes.

- Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits.

- Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs.

- Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation.

- Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings.

Ethics:

- Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants in non-complex studies.

- These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record).

- Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review.

Data:

- Enters basic data for research studies. Scores tests and measures that do not require interpretation, according to the protocol. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies.

- Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required.

Science:

May assist with simple literature searches under supervision from PI or CRC. Demonstrates a basic understanding of the elements of research study designs.

Study and Site Management:

- As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system.

- Records basic protocol information in clinical research management system. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order.

- Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership:

- Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).

- Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

- Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates with other study personnel as required for study implementation and routine problem resolution.

Minimum Qualifications

Education

Work requires an Associate's degree.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience.

Duke 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 essentialjob 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.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

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