CLINICAL RESEARCH SPECIALIST, SR
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.
TYPE OF RESEARCH:
This candidate will be working in the Primary Care Research Consortium (PCRC)with study populations that range from pediatrics to geriatrics. The PCRC study complexity is typically limited and more pragmatic than complex. PCRC studies are typically minimal risk and do not involve interventions. This candidate will work under the regular supervision of the Primary Care Investigator, PCRC supervisor, and clinical research coordinators.
Work hours are typically 8am-5pm with a 1 hour lunch; however, some flexibility to work before clinic (7:00 or 7:30 am), at lunchtime, or at the end of the workday (past 5:00 pm) may be needed for study-related meetings with practice providers and staff.
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).
Prepares for, and provides support, study monitoring, and audit visits, including support for the reviewer. Addresses and corrects findings. May train others.
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.
Employs and may develop strategies to maintain recruitment rates and evaluate processesto identify problems. Escalates issues. May train or oversee others.
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 (excluding those requiring EHR access).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.
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 upervision, for non-complex studies (e.g., survey studies and registries ), develops and submits documentation and information for IRB review.
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-complexstudies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance.
Recognizes and reports security of physical and electronic data vulnerabilities. Independently uses and implements technology to enhance productivity orproces s. May train or oversee others.
Assists with simple literature searches. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs.
STUDY and SITE MANAGEMENT:
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CRO s.
Records participant accrual information in clinical research management system. For studies with simple supplies or equipment, nsures 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).
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.). Demonstrates interpersonal skills to get work done efficiently.
Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
PORTFOLIO RESPONSIBILITIES (Effort %):
Clinical Research Operations (33%): screen, schedule, conduct study visitsand consent participants in minimal risk studies, including documentation of consent in the EMR; Prepare documents, equipment or supplies for research visits. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs; Employ strategies to maintain recruitment and retention rates and to assist study participants with individual needs.
Clinical Research Operations (15%): Collect, prepare, process, ship and maintain inventory of research specimens and train others in these tasks. Collect, prepare or process adverse event information under supervision. Provide input for adverse event reports. Assist with m aintenance of study level documentation. Prepare for study monitoring or audit visits.
Clinical Research Operations (5%): Provide input for IRB documents such asconsent forms, protocols and continuing reviews.
Ethical and Participant Safety Considerations (5%): Maintain familiaritywith the ethical conduct of research and safeguards needed with conducting research with vulnerable populations; Understand that the safety of research participants is a priority.
Data Management and Informatics (15%): Use and train others in EDC systems, technologies, and software necessary for study operations; Enter data accurately; Score test and measures according to protocol and role; Complete paper and EDC case report forms accurately and according to protocol; Assist with the development of data collection documents to standardize processes; Map a protocol's data flow plan, including data capture, storage , management, quality and preparation for analysis. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data; follow and assist with development of SOPs for data quality assurance; run summaries and reports on existing data; Use required processes, policies and systems to ensure data security and prove nance. Recognize and report vulnerabilities related to security of physical and electronic data.
Scientific Concepts and Research Design (2%): conduct literature reviews under direction of the CRC or PI. I dentify various stakeholders (statistical, operational) to ensure adequate design, implementation and testing of study aims.
Leader ship and Professionalism/Communication and Team Science (10%): Encourage and support colleagues in completion of project work; assist research colleagues in identifying efficiencies and improving processes; Participate in study team meetings; Respond to routine questions related to study protocols;Communicate and coordinate with other study personnel as required for implementation and routine problem resolution.
Study and Site Management (10%): Participate in sponsor-required training. Maintain inventory of study supplies and equipment; prepare items for site initiation visits and take part in such visit as directed.
Scientific Concepts and Research Design (2%): conduct literature reviews under direction of the CRC or PI. Identify various stakeholders (statistical, operational) to ensure adequate design, implementation and testing of study aims.
Work requires an Associate's degree.
One year of relevant experience. A Bachelor's degree may substitute for required experience.
Willingness to engage potential participants in conversation on phone and in-person; Microsoft Office skills (especially Excel); Strong verbal andwritten communication skills.
Preferred but not required:
Bilingual in Spanish; Familiarity with Duke systems; Addi tional skills in database management and electronic data capture systems (e.g., Access, REDCap).
Ability to travel to community clinics for participant enrollment and follow-up may be needed (mileage is reimbursed according to guidelines).
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.