Administrative/Project Manager

Summary:

• Work Mode: Fully Remote
• Duration: 3 months
• Work Schedule: 8am – 5pm

Responsibilities:

• 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.