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About the position
Duke University School of Medicine is seeking a Clinical Research Coordinator to oversee a study examining how emotion regulation skills training in pregnancy could improve emotion regulation and newborn neurobehavior. The position requires strong interpersonal skills to communicate effectively with stressed pregnant women and involves direct interaction with participants for recruitment and scheduling assessments. The role also includes monitoring recruitment and retention rates, necessitating a flexible schedule that may include night and weekend study visits.
Responsibilities
- Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
- Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
- Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
- Maintains participant level documentation for all studies, including those that are complex in nature.
- Employ strategies to maintain retention rates and evaluate processes to identify problems with retention.
- Screens participants for complex studies and develops or helps develop SOPs.
- Conducts activities for study visits in compliance with the protocol.
- Leads effective facilitation of team meetings to achieve objectives.
- Identifies all AEs, and determines whether or not they are reportable.
- Collaborates with the PI to determine AE attributes, including relatedness to study.
- Develops consent plans and documents for participants in a variety of studies.
- Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
- Enters and collects data, develops data entry or collection SOPs or tools.
- Independently responds to queries created by a CRO or the data manager.
- Develops reports on study progress for the PI and other study team members and collaborators.
- Records participant accrual information and consent documentation for non-complex studies in clinical research management system.
- Encourages staff to take part in professional development opportunities.
Requirements
- Completion of an Associate's degree.
- Minimum of two years of relevant research experience; a Bachelor's degree may substitute for 2 years required experience.
Nice-to-haves
- Strong interpersonal skills.
