CLINICAL RESEARCH COORDINATOR

Duke Careers•Durham, NC

95d•Onsite

About The Position

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. Our team is looking for a proactive, self-motivated team member who is comfortable working both independently and, in a team setting, and interfacing with Principal Investigators. This individual will support multiple research studies in the Reproductive Endocrinology and Infertility (REI) division of OBGYN, conducted by multiple investigators. Duties will include screening for research studies, obtaining written consent, conducting study visits, maintaining participant level documentation, and collecting, processing, and transporting research specimens. This position may also assist the Assistant Research Practice Manager with regulatory tasks. This position will work alongside and interact with multiple team members including: research staff, clinic staff and providers, surgeons, OR staff, hospital staff. This position is 100% on site.

Requirements

Highly organized
Excellent attention to detail and communication skills
Ability to successfully balance multiple competing priorities
Comfortable in an Operating Room setting
Comfortable collecting, processing, and transporting biological specimens
Has a valid driver's license and reliable means of transportation
Education/Training: Completion of an Associate’s Degree
Experience: Work requires a minimum of two years relevant research experience. A bachelor’s degree may substitute for 2 years required experience.

Nice To Haves

ACRP or SOCRA certification preferred.

Responsibilities

Knowledgeable in regulatory and institutional policies and processes
Applies appropriately in study documentation, protocol submissions, and SOPs.
May train others in these policies and processes.
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/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects findings.
Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention.
Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.
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 SOPs.
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Conducts activities for study visits in compliance with the protocol.
Participates in study team meetings.
Identifies all Adverse Events(AE), and determines whether or not they are reportable. Collaborates with the Principal Investigator to determine AE attributes, including relatedness to study.
May train or oversee others.
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.
Assists with the development of consent plans and documents for participants.
Develop and submit documentation for IRB review in iRIS.
Communicate with the IRB staff and reviewers and handle issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Data:
Develops data entry or collection SOPs or tools.
Enters and collects data.
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.
Follows required processes, policies, and systems to ensure data security and provenance. Innovatively uses technology to enhance a research process.
Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants.
Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators. Science:
Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship). 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.
Uses OnCore and eREG systems and system reports to manage research protocols. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs.
Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).
Prepares studies for closeout and document storage.
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 and is adaptive to change.
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Benefits

Duke provides comprehensive and competitive medical and den tal careprograms, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

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