Posted in Other 7 days ago.
Location: Durham, North Carolina
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.
100% Grant funded
This Gastroenterology Clinical Research Coordinator will be responsible for identifying eligible study participants, providing informed consent, performing study visits, collecting survey/EMR data, specimen collection/management, in compliance with sponsor, regulatory, and institutional guidelines. Study types include industry, federal, foundation, and investigator initiated. In addition to recruiting within GI and endoscopy clinics, this position may liaise with other clinics to maximize subject recruitment. This Clinical Research Professional will be integrated into a larger clinical research team and is expected to collaborate on studies that will further the research mission of the NAFLD program as specified by the Principal Investigator who directs this research program. The Principal Investigator will provide ultimate supervision, regulatory oversight, mentorship, and guidance in the conduct of research.
· Screens participants for complex studies (e.g., procedural and interventional studies).
· Recruits research participants according to study protocol.
· Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
· Evaluates processes to identify problems with retention and employ strategies to maintain retention.
· Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.
· Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
· Conducts and plans for complex study visits.
· Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
· Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
· Assists with study level documentation and approvals for international studies.
· Serves as the primary liaison with sponsors, IDS, and other parties as necessary.
· Follows protocol schema for randomization and blinding/unblinding.
· Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
· Prepares for and provides support for study monitoring and audit visits, including support for the reviewer; addresses and corrects findings.
· Participates in study team meetings.
· Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care.
· Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team.
· Assists with the development of consent plans and documents for participants.
· Develops and submits documentation and information for IRB review.
· Communicates with the IRB staff and reviewers and handles issues appropriately.
· Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Data:
· Collects and enters data.
· Develops data entry or collection SOPs or tools.
· Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
· Recognizes data quality trends and escalates as appropriate.
· Recognizes and reports security of physical and electronic data vulnerabilities.
· May develop or review RDSPs for multiple study protocols.
· Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
· Independently uses and implements technology to enhance productivity or process.
· Assists with or contributes to the development of funding proposals.
· Independently conducts literature searches and reviews.
· Using scientific proposals from the PI, develops research protocols.
· Demonstrates a basic understanding of the elements of research study designs. Study and Site Management:
· Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.
· Uses required EMR functionalities to manage participants and study visits.
· Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information.
· For studies with complex 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.
· Prepares for, coordinates, and actively participates in site visits.
· Communicates effectively with sponsors and/or CROs.
· Follows, and may develop or implement, protocol-specific systems and documents including process flows.
· Prepares studies for closeout and document storage. Leadership:
· Works with the manager to understand areas of opportunity and develop a training plan.
· Takes training courses and applies the knowledge and skills.
· Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.
· Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.
· Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
· Demonstrates resilience and is adaptive to change.
· Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
· Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Special skills: Candidate will possess exquisite communication skills, ability to work in teams, as well as perform autonomously. Candidate will have basic computer knowledge, including MSOffice and Outlook calendaring. Previous research in recruiting, consenting, and tracking/charting patients in a clinic environment is preferred. ACRP or SOCRA certification suggested at earliest eligibility.
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years 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.