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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.
Duke University's Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has an immediate opportunity for a motivated individual to fill a Clinical Research Coordinator position in their research operations.
MC3 Vision: To live in a world where every person has access to high quality and effective cell based therapies
MC3 Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health
This position involves research into the safety and efficacy of cell therapies for a variety of conditions. Studies are FDA regulated and range from phase 1 to phase 3 and include children or adults. Conditions being studies include autism, cerebral palsy, HIE, Multiple Sclerosis, and Inherited Metabolic Disorders. The candidate must be an effective team player and have outstanding attention to detail and strong written communication skills. Education or a background in a medical field or biology is preferred.
Recruits research participants according to study protocol. Screens participants for complex studies (e.g., procedural and interventional studies). Follows SOPs and strategies to manage and retain research subjects. Conducts and plans for complex study visits. 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. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. Develops or helps develop SOPs. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. May train staff. 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 for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.
Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance.
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 CROs. 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. Records basic protocol information in clinical research management system. 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 actively facilitates the research program through 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.
Description of Portfolio Responsibilities:
1. Screening potential study participants for eligibility
2. Maintenance of IRB applications and submissions
3. Management of subject study visits and documentation
4. Submission of study data and subject follow up
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.