Clinical Research Coordinator - Obstetrics And Gynecology

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Duke University’s Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Coordinator.

Occupational Summary:

This position will be part of the Perinatal Research team, which conducts studies in pregnant and postpartum individuals, as well as their babies. Spanish fluency is strongly preferred. This role may train or oversee others.

Work Performed:

Operations:

Prepares FDA regulatory submissions in collaboration with 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 SOPs. May train others in these policies and processes.

Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. 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.

Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for complex studies (e.g., procedural and interventional studies).

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).

Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings.

Ethics:

Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE 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.

Assists with the development of consent plans 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.
Data:

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. 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. Independently uses and implements technology to enhance productivity or process.
Study and Site Management:

As directed, attends or schedules 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.

For studies with simple supplies or equipment, assists with ensuring 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).
Leadership:
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.). 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.

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

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.