Description

• To manage all aspects of assigned clinical studies including education.

• To develop protocol-specific systems and documents.

• To act as a consultant within area of clinical expertise.

• To identify various stakeholders to ensure adequate design, implementation, and testing of study aims.

• To assess and determine solutions for operational shortcomings for data procurement in protocol design.

• To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.

Primary Responsibilities

• Facilitate the preparation and submission of required documents to institutional review boards (IRBs).

• Develop and manage the research study budget, including monitoring expenses and ensuring financial accountability.

• Manage the research study budget, including monitoring expenses and monthly reconciliation.

• Coordinate with finance and pre/post-award departments for budget approvals and allocations.

• Supervise and coordinate the activities of the small research team.

• Facilitate communication and collaboration among study team members, external site PIs, and administrators/clinicians.

• Monitor participant enrollment and retention, addressing any challenges that may arise.

• Oversee data collection, ensuring accuracy, completeness, and adherence to study protocols.

• Provide regular updates to stakeholders, including investigators, sponsors, and internal/external institutional leadership.

• Prepare and submit progress reports to funding agencies and IRB.

• Address and resolve issues as they arise during the study.

• Coordinate study closeout activities, including final data analysis, report writing, and archiving of study documents.

• Ensure compliance with reporting requirements to regulatory agencies and sponsors.

• Liaise with external collaborators, vendors, and subcontractors as needed.

• Perform other duties as assigned.

Annual Salary Range - $60,835 - $98,855

Qualifications

Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.

Preferred Qualifications

• Master's degree and related experience preferred.

• Strong organizational skills.

• Ability to multi-task.

• Experience with minoritized communities.

Primary Location

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Organization

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