Clinical Trial Project Manager

Randstad Enterprise Solutions in partnership with Mass General Brigham are actively seeking a Clinical Trial Project Manager. Mass General Brigham is an integrated healthcare system built on a legacy of two leading academic medical centers. Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, two of the nation’s leading academic medical centers with rich histories and tradition. Today, Mass General Brigham is a 16 member institution encompassing a range of health care organizations committed to serving the community.

100% remote Potisiton

6-12 Month Contract

Pay rate: $45 per hour - $55 per hour

Expectations for All Employees:

Supports the organization’s missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership

Position Summary:

This role is a Clinical Trial Project Manager will conduct two Phase 2 multi-centered studies in pain research conducted under NIHs Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net seeks to enhance the treatment of acute and chronic pain and reduce reliance on opioids by accelerating early-phase clinical trials of non-addictive treatments for pain. The Trial Project Manager will focus on managing clinical operations within the trial.

Competencies Required:

• Excellent communication skills
• Sound interpersonal skills
• Ability to work independently and display initiative to introduce innovations to research study
• Ability to identify problems and develop solutions
• Ability to multi-task
• Ability to prioritize tasks and set deadlines

Responsibilities:

• Work with PI/Sponsor on grant submission (if required)
• Work with PI/Sponsor to submit IND (if required)
• Manage all regulatory communication
• Finalize protocol synopsis
• Initiate Project Team meetings, provide agendas and minutes
• Develop study timelines
• Work with Program Managers to facilitate third party contract process
• Ensure that reliance agreements are completed between the cIRB and sites
• Develop site and EPPIC-NET-CCC study manuals
• Work with EPPIC-NET-DCC to finalize case report forms (CRFs) and to facilitate database build process
• Work with Senior Grants and Contracts Administrator to facilitate contract process Work with Central Pharmacy to facilitate study drug packaging/labeling as needed
• Plan and conduct Study Orientation/Initiation Meeting
• Post trial on clinicaltrials.gov
• Manage key study events including; serious adverse events, dosage adjustments, premature study withdrawals, etc.
• Work with Study Monitors to manage protocol compliance and GCP issues at each site, review monitoring reports and ensure proper documentation of PI/Sponsor oversight
• Provide Project Team with timeline for study reports
• Manage independent review process
• Work with EPPIC-NET-DCC, Site Managers and Study Monitors and sites to ensure all queries are answered appropriately and closed prior to database lock
• Assist with preparing abstracts, manuscripts and/or clinical trial reports
• Post results on clinicaltrials.gov within 12 months of database lock
• Additional tasks may be added as needed for the Project Managers depending on protocols.

Requirements:

• Candidates should have B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
• 2 - 4 years of clinical research/trial experience.
• Highly proficient in software applications such as Word, Excel and PowerPoint.
• Strong organizational, documentation and communication skills with an ability to multitask.
• Excellent interpersonal skills; ability to collaborate across disciplines.
• Ability to work remotely

Work Schedule:

• Monday through Friday, 9:00AM to 5:30PM