Senior Clinical Research Coordinator

Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon Center needs. Similarly, it is not intended to be construed as an exhaustive statement of all duties, responsibilities, or skills of personnel so classified.

Study Start-Up:

Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
Assist with creation and editing of study documents, such as protocols, consent forms, and subject communications.
Study Maintenance and Regulatory Compliance:

Recruitment, enrollment, consent, and tracking of participants.
Collect and organize participant data.
Assist with preparation of annual review documents and progress reports.
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
Verify accuracy of study forms.
Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
Documents patient visits and procedures.
Designs research protocols in conjunction with PI
Acts as a liaison between study teams and Human Research Affairs
Recommends protocol changes and submits adverse events
Program Management:

May coordinate multi-site trials coordinators in conjunction with Program Manager/Director
Quality Assurance:

Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
Prepares data for analysis and data entry.
Administrative Support:

Performs varied administrative support duties as required.
Communicates professionally and effectively with internal and external study collaborators, including investigators, sponsors, and monitors.
Plans and coordinates trainings and/or conference calls with external collaborators.
Conducts literature searches.
Assists PI to prepare complete study reports.
Assists Investigators with the preparation of posters and analyses for publication.
Grant Administration:

May design budgets in conjunction with the center Grant Administrator
May draft annual reports to sponsors and stakeholders in conjunction with PI
Supervisory Responsibility:

A Senior Clinical Research Coordinator may train, orient, and address competency of staff, interns, and volunteers