NextGen Jane is seeking a Clinical Research Coordinator. This job will include key responsibilities in clinical study management and logistics that include research development and study strategy, as well as study planning and execution within pre-specified clinical research programs. The candidate will be responsible for managing timelines, record keeping, data management, IRB multi-site coordination, and ensuring HIPAA and ethics review board compliance throughout study timeline. The candidate will prepare study related materials for executive team and outside collaborators, manage relationships between study sites, staff, and patient participants. The candidate will also supervise study related activities such as enrollment, participant consent, and data auditing.
Primary Duties and Responsibilities
- Assist in developing recruitment strategies.
- Participate in the review and writing of protocols to ensure IRB approval
- Determine eligibility of, and gather consent documents from study participants according to protocols.
- Serve as primary contact with research participants.
- Assemble study kits participants, monitor scheduling of consenting, coordinate documents, and attend monitoring meetings, acting as primary contact.
- Coordinate collection of study specimens and processing.
Collect and manage patient and laboratory data for clinical research projects.
- Manage Laboratory/Clinical Information Management Software (LIMS), develop flow sheets and other study related documents, and complete study documents/reporting forms.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Ensure compliance with research protocols, and review and audit forms for completion and accuracy. Help prepare regulatory submissions for Institutional Review Board (IRB) approval.
Ensure and comply with data privacy policies
- Participate in regulatory audits.
One to two years of related work experience or a Bachelor’s degree in a related field with some experience. At least one year of experience in human subjects research in an academic and/or medical setting. Professional credentialing (CCRP/CCRA) is not required but desirable.
- Strong interpersonal skills
- Highly organized approach to work with strong attention to detail
- Proficiency with Microsoft Office, including Word, PowerPoint, and Excel
- Effective verbal and written communication skills to coordinate with subjects
- Empathic nature and willingness to engage and listen to patients
- Experience working with information management software (highly desired)