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 sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.
Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health.
a world-class academic medical center.
The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools.
Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.
Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 health professions and biomedical PhD students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health.
a world-class academic medical center.
The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke HomeCare & Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary This position will work closely with two dynamic teams within the Department of Population Health Sciences and the Duke Cancer Institute.
Our program uses theoretical frameworks and methods from social and molecular epidemiology to investigate health disparities across the cancer prevention continuum in the U.
S.
and abroad.
Ongoing projects involve collaborative studies to understand and address the fundamental causes of cancer disparities.
The Clinical Research Specialist, Sr (CRS Sr.
) will work in a vibrant, team-based and diverse environment to perform a variety of research and program management duties to support our cancer research and community outreach programs, under the direction of a Clinical Research Coordinator (CRC) or similar Clinical Research Unit (CRU)/ Oversight Organization (OO) designee.
Work Performed 1.
Research Operations and Data Entry: Under supervision, may document some participant-level information for non-complex studies (e.
g.
, questionnaire) and employ simple procedures for collecting and managing research data and specimens.
Prepares documents and conducts scripted interviews to collect patient level data.
Enters basic data for research studies and assists with maintenance of study level documentation.
Recruits research participants according to study protocol and follows standard operating procedures (SOPs) and strategies to manage and retain research subjects.
Schedules 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.
May assist with study level documentation and approvals for international studies.
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
Follows standard operating procedures(SOPs) and strategies to manage and retain research subjects.
Follows SOPs for quality assurance.
Follows required processes, policies, and systems to ensure data security and provenance.
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.
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.
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 suppliesor equipment, ensures that there are ample supplies and that equipment is in good working order.
Follows protocol-specific systems and process flows 5.
Leadership and Professionalism: Actively participates in study team meetings.
Maintains Duke and project-specific training requirements.
Communicates with team as required for project implementation and routine problem resolution.
The Department of Population Health Sciences aspires to create a community built on collaboration, innovation,creativity, equity, and inclusivity of others without biases or prejudice of any kind.
Our collective success depends on arobust exchange of ideas - an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes.
To achieve this exchange, we are committed to diversity in the staff and faculty we hire, the policies we create,and the decisions we make.
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.