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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Job Title: Clinical Research Specialist, Sr.

Primary Role:
The Clinical Research Specialist Sr., within the Duke Office of Clinical Research will assist with identifying potential research participants and matching them with clinical research studies that fit their health and research interests. The team member in this position will support recruitment efforts through the management of provider referrals, communication with Investigators, study teams, the Research Concierge service (myRESEARCHpartners) and patients to pre-screen them for open clinical trials and connect them to the appropriate study coordinator or investigator. The person in this position will be part of a team working to enhance the interests of Duke by engaging patient and community members in meaningful partnerships to advance clinical research and improve the pipeline of beneficial therapies. Critical to this role is strong written and oral communication skills and a commitment to reducing health disparities through engagement of all communities in clinical research.

Essential Task /Responsibilities:

Recruitment and Screening:

• Uses electronic health record management systems and database tools to identify patients and individuals from the community who may be eligible for active clinical trials and research studies at Duke. Interfaces with various call centers and technologies to take and answer questions from potential participants regarding studies in which they may be interested. Communicates with providers, receiving and processing referrals of patients to clinical trials. Communicates with Principal Investigators and study teams regarding recruitment and engagement goals and participants who may be interested in their studies. Uses databases and other data systems to manage participant interest and communications. Works with cores and offices across Duke to enhance research partnerships throughout the community.

• Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.
• Screens participants in person or over the phone for multiple studies or may collect information from the EHR to assist study team in determining eligibility. Follows SOPs and strategies to manage and retain research subjects. Prepares necessary documents, equipment, supplies, etc.

Research Conduct:

• 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. 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.
  
• Assists with study level documentation and approvals. 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. Escalates issues. Follows SOPs. Assists with maintenance of study level documentation. Schedules participants for research visits. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study and/or recruitment team meetings. Assists with the development of consent plans, recruitment materials, 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.

• 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, ensures 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).

• May assist with simple literature searches under supervision from PI or CRC.

Education/training:

Required: Work requires an Associate’s degree.

Experience:

Required: One year of relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Skills:

Can easily use computing software and web-based applications (e.g., Microsoft Office products

and internet browsers).

Special skills:
Preferred skills include excellent technical and communication skills, phlebotomy, familiarity with electronic health record systems (EPIC).

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.