CLINICAL RESEARCH SPECIALIST, SR

Job description

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.

Occupational Summary

100% Grant funded

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical nutrition research under the supervision of a Clinical Research Coordinator and the PIs of the studies. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data. This will include in-person conduct of tests such as functional assessment and the processing/transfer/storage of biological samples, as well as assisting with record filing and data management. May train others such as Clinical Research Specialists (CRS) and student research aids in related tasks. Research locations include the Durham VA Medical Center and at several locations on the main Duke medical school campus.

Work Performed

1. Research Operations. Assists with in-person and web-based recruitment of study participants. Screen participants in-person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the electronic health record (EHR) to assist study team in determining eligibility. Follows standard operating procedures (SOPs) and strategies to manage and retain research subjects. Schedule participants for research visits and prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews and may manage participant payment. Physical testing may include function tests, 24-hr ambulatory blood pressure, mini-cognitive assessment, height, weight, waist circumference, and body composition measurements with BodPod. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. May assist with study level documentation and approvals for international studies and with preparation for study monitoring and audit visits. Independently employs simple procedures or collecting, preparing, processing, shipping, and maintaining inventory of specimens. Sample management examples include processing of blood urine and fecal samples for storage and analysis. Follows SOPs and participates in study team meetings. Maintains excellent communication between CRC, interventionists, and PIs.

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. Assists with the development of consent plans and documents for participants.

3. Data. Enters and collects basic data for research studies, including management and entry of data into redcap data bases and excel spread sheet records for study management. 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. Leadership and Professionalism. Works with the CRC and lab directors 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.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Preferred Skills

Strong organizational skills and attention to detail in management of clinical data are essential. Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers). Willing to work in-person at various clinical data collection sites around campus on a regular basis. Previous experience working in clinical research at Duke is preferred.

Required Qualifications at this Level

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.

 

 

 

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Job No:
Posted: 4/25/2021
Application Due: 7/24/2021
Work Type: Full Time
Salary: