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CLINICAL RESEARCH SPECIALIST, SR - COORDS Project

Requisition Number::  129529
Date:  Aug 28, 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 Orthopaedic Surgery has an opening as a Clinical Research Specialist, Sr. 

 

Occupational Summary

 

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the Duke Joint Health Program and the COORDS Program under the supervision Dr. William Jiranek. 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. Position also coordinates the work of undergraduate and graduate students.

 

 

Work Performed

1. Research Operations. Screens participants in person or over the phone with weekly surveys, gathers survey results and enter into database; analyze data and produce reports as requested using spreadsheets and databases, the statistical software “R”, and ACE-Business Objects Pro Database (ACE). May recruits research participants according to study protocol. Follows standard operating procedures (SOPs) and strategies to manage and retain research subjects. Prepares necessary documents for research visits. Conducts and documents non-complex survey completion. Maintains participant- level documentation for non-complex (e.g., questionnaire, data registry, scripted) studiesfor the Duke Joint Health Program and the COORDS program. Assists with establishing and maintaining study-level documentation. May assist with study level documentation and approvals for international studies. Under supervision, may assist with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering) and prepares for study monitoring and audit visits. Follows SOPs and participates in study team meetings.

2. Safety and 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.

3. Data. Enters and collects basic data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate, or missing data for non-complex studies and 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.

4. Scientific Concepts. Assists with simple literature searches. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Provides some contribution to scientific publications or presentations (no authorship).

5. Site and Study Management. As directed, attends or schedules site visits and assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor). Associates patients with studies in CRMS. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows.

6. Fully participates in on-the-job learning for associated software as well as the ACE Data Dictionaries and consistently demonstrates the competencies gained to perform the job.

6. Leadership and Professionalism. Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Communicates with other study personnel as required for study implementation and routine problem resolution.

 

Required Qualifications at this Level

 

Education/Training: Work requires an Associate's degree.

 

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

 

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

 

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