Clinical Research Specialist, Sr. - Obstetrics and Gynecology

Duke University - Durham, NC

Full-time - Entry Level

Durham, NC

5,001-10,000 employees

Educational Services

About the position

Duke University's Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Specialist Sr. in their Perinatal Division. This is an in-person position based at the Perinatal Research Center in Durham, with travel to outlying prenatal clinics in Durham and Wake Counties. Spanish fluent is strongly preferred. This position will be part of the Perinatal Research team, which conducts studies in pregnant and postpartum individuals, as well as their babies both in the outpatient and inpatient settings. We are specifically looking for a highly motivated, team-oriented individual to integrate into a number of grant, foundation and industry-funded non-treatment trials.

Responsibilities

• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
• Prepares for study monitoring and audit visits under supervision.
• Maintains participant-level documentation for non-complex studies outside of the EHR.
• Recruits research participants according to study protocol.
• Screens participants in person or over the phone for non-complex studies.
• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
• Schedules participants for research visits and prepares necessary documents, equipment, supplies, etc. in compliance with the protocol.
• Conducts and documents non-complex visits and scripted testing or interviews.
• Participates in study team meetings.
• Collects information about AEs under supervision.
• Conducts and documents consent for participants in non-complex studies.
• Enters and collects basic data for research studies.
• Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies.
• Runs summaries and reports on existing data.
• Attends or schedules site visits as directed.
• Records participant accrual information and consent documentation for non-complex studies.
• Assists in preparing studies for closeout as directed.
• Works with the manager to understand areas of opportunity and develop a training plan.
• Keeps current with research updates by attending key external departmental meetings.

Requirements

• Work requires an Associate's degree.
• One year of relevant experience. A Bachelor's degree may substitute for required experience.

Nice-to-haves

• Fluency in Spanish is strongly preferred.