Clinical Research Coordinator II-Movement Disorders

Vanderbilt University Medical Center•Nashville, TN

About The Position

The Clinical Research Coordinator II is responsible for coordinating research protocol approval processes and conducting clinical and translational research while maintaining research integrity and quality and complying with applicable policies. The role works under occasional guidance and supports study activities throughout the research lifecycle, including regulatory submissions, documentation, participant screening and enrollment, data collection, specimen handling, budget administration, and participant protections. The coordinator prepares and processes IRB proposals, amendments, continuing reviews, and adverse-event reports; maintains study records for institutional, sponsor, and regulatory review; and helps procure required study equipment and supplies. The position supports participant eligibility assessment, screening, recruitment, informed consent, and ongoing monitoring. It also records and manages study data, resolves queries, ships specimens according to applicable guidelines, and assists with study budgets and billing compliance. The coordinator communicates with investigators, research staff, sponsors, participants, and other stakeholders, and participates in research-related programs and activities.

Requirements

Bachelor's degree.
At least 1 year of relevant work experience.
Ability to prepare and process research regulatory submissions and maintain compliant clinical or translational research documentation.
Ability to support participant screening, eligibility assessment, recruitment, informed consent, and study data collection.
Ability to communicate clearly, effectively, and respectfully with employees or customers.

Responsibilities

Prepare and process new IRB research proposals, amendments, continuing review applications, and adverse-event reports in accordance with institutional and departmental policies and federal regulations.
Prepare and maintain study documents required internally and for sponsor or regulatory-authority review before, during, and after a trial; participate in site visits reviewing research, source documentation, critical documents, and procedures.
Identify and procure equipment and supplies needed to meet project requirements, including across multiple sites when required.
Help determine candidate eligibility, assess medical and historical information, and implement screening and recruitment strategies to support timely study completion and appropriate enrollment and continued participation.
Record data from source documentation or participant interactions on paper or electronic case report forms, ensuring accuracy, completeness, and timeliness; resolve queries promptly and maintain research information in compliance with regulations, policies, and good clinical practice.
Package and ship study specimens to sponsors or laboratories according to sponsor instructions and shipping regulations, maintaining appropriate documentation.
With direction, develop and manage study budgets, monitor invoicing, maintain clinical trial billing compliance, and provide reports to investigators, department administration, and funding agencies.
Advocate for human subjects through communication with investigators, research staff, sponsors, participants, professional organizations, participant advocates, and the public, and through ongoing monitoring of trial processes and participants.
Participate in the ongoing informed-consent process and help ensure participants, families, and health care providers understand expectations for trial participation.
Participate in research-related programs, including the Clinical/Translational Research Staff Council, by raising issues, suggesting solutions, reviewing information, attending meetings, and sharing information with research personnel.
Provide administrative and logistics support for project meetings, training, workshops, and facilitated sessions; coordinate and track work requests, update project plans, and maintain project records and repositories, as applicable to project coordination duties.
Perform other duties as assigned.