Serve as the primary point of contact for investigators, regulatory coordinators, study coordinators, data managers, research staff, and study monitors.
Provide project management support and oversight for assigned investigator-initiated clinical research studies.
Ensure accurate and timely writing of protocols and study documents.
Assist with the preparation and completion of FDA IND, DSMB, IRB, and other regulatory submissions.
Review and follow up on study data and monitoring findings.
Assist with maintaining regulatory files to fulfill research requirements and meet established study timelines.
Collaborate with study teams and study monitors to support data quality.
Ensure study documentation is complete, accurate, and maintained in a timely manner.
Manage assignments from the team Director and study investigators, adjusting priorities based on study and departmental needs.
Ensure studies and patient care needs are addressed appropriately and in a timely manner.
Requirements:
Experience or demonstrated ability in clinical research project management, preferably involving Investigator Initiated Trials (IITs).
Knowledge of clinical research protocols, study documentation, and regulatory processes.
Familiarity with FDA IND, DSMB, IRB, and other regulatory submissions.
Ability to review study data, address monitoring findings, and maintain accurate regulatory documentation.
Strong organizational and time management skills, with the ability to meet established study timelines.
Ability to work independently and collaboratively with multidisciplinary research teams.
Strong written communication skills, particularly in protocol and study document preparation.
Excellent interpersonal and communication skills to coordinate with investigators, research staff, and study monitors.
Ability to manage multiple assignments and adjust priorities based on changing study and departmental needs.
Strong attention to detail and commitment to maintaining data quality and documentation accuracy.