CLINICAL RESEARCH COORDINATOR
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.
- Recognizes when typical agreements (Material Transfer Agreements (MTA), Confidential Disclosure Agreement [(CDA), Data Use Agreement (DUA), Data Transfer Agreement (DTA), etc.) are necessary and alerts appropriate parties.
- Prepares Food and Drug Administration (FDA) regulatory submissions in collaboration with The Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and maintenance of relevant documentation.
- Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).
- Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and Standard Operating Procedures.
- Maintains study level documentation for international studies.
- May develop resources and tools for management of international studies, and/or coordinate with other entities or offices.
- Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
- Serves as the primary liaison with sponsors, IDS, and other parties as necessary.
- Follows protocol schema for randomization and blinding/un-blinding.
- Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
- 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 Medical Record.
- Employs strategies to maintain retention rates.
- Evaluates processes to identify problems with retention. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals and provides training.
- Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams.
- Develops or helps develop standard operating procedures (SOPs).
- 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.
- Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
- May train or oversee others in the above procedures and activities.
- Identifies all Adverse Events, and determines with PI oversight whether or not they are reportable.Collaborates with the PI to determine adverse events attributes, including relatedness to study. 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. Develops consent plans and documents for participants in a variety of studies. 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. May train or oversee others in the above activities and processes.
- Collects and enters study data in the appropriate data platform. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature.Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from Electronic Data Capture (EDC) systems, Electronic Medical Record (EMR), mobile apps, etc.). Independently uses and implements technology to enhance productivity or process. May train or oversee others in the above activities and processes.
- Assists with or contributes to the development of funding proposals. Assists with simple literature searches. Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications.
- Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. 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. May train others in EMR functions. 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. May train others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast staffing needs. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows. Prepares studies for closeout and document storage. May train or oversee others. May train or oversee others in the above activities and processes.
- Proactively seeks opportunities to add relevant skills and certifications to own portfolio. 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. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process.Demonstrates resilience, leadership, and actively facilitates change for research portfolio. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.
Description of Clinical Responsibilities:
Clinical responsibilities: n/a
Type of Research:
This position spans a broad range of clinical research that evaluates the management of patients with spinal disorders, specifically evaluating spinal trauma, spinal cord injury, pediatric and adult spinal deformity, degenerative spinal disorders, spondylolisthesis, and spinal stenosis. The focus of Duke Spine Division studies is to improve the selection of patients for optimal treatment, reduce complications related to treatment, and improve outcomes.
The ideal candidate will have prior experience as a clinical research coordinator, preferably in neurosciences/ neurosurgery, prior patient interaction experience, recent experience in all aspects as a Clinical Research Coordinator including developing, editing and submitting study applications to the Institutional Review Board for review, consent process, study documentation, study regulatory maintenance, as well as effectively implementing study protocols independently. Proficiency in Word, Excel, Microsoft Teams, Power Point and general technical skills is desired. Professional level writing skills is required. Prefer a candidate with experience in EPIC. This candidate should possess a basic background in scientific/medical concepts, have exceptional organizational and time management skills, be adaptive to change, and possess excellent communication and problem solving skills. The ideal candidate will have strong relationship building skills which promote cooperative, collaborative and creative partnerships within a diverse team. Minimum Qualifications
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.