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7 days old

Senior Clinical Trial Associate

GlycoMimetics, Inc.
Rockville, Maryland

Job Summary:

The Senior Clinical Trial Associate will provide in-house support for clinical trial operations including but not limited to, interacting with the Contract Research Organizations (CROs), clinical research associates (CRAs) and clinical investigative sites, maintaining appropriate in-house trial documentation and providing general support for the clinical operational activities of the company. Works under supervision.

Job Duties:

  • Provides support to the clinical trial operations team; helps ensure that studies are completed on time, and in compliance with SOPs, FDA regulations, and ICH/GCP
  • Administer the Trial Master File (TMF), as applicable – responsibilities include but are not limited to: review of project and site documents for completeness and accuracy for inclusion into the TMF; builds structure and maintains the TMF; evaluates progress, determines gaps, and proposes solutions to resolve/document TMF non-compliance
  • Obtains and reviews essential documents to authorize initial study drug shipment to site(s)
  • Develops and maintains study-related trackers that will support clinical operations and the TMF. May analyze data associated with the trackers
  • Assists in reviewing and finalizing study-related templates, plans and manuals
  • Interacts with site clinical research coordinators and study staff to ensure smooth operation and documentation of trials under Good Clinical Practice [GCP] guidelines
  • Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for investigator meetings and monitoring visits (qualification, study initiation, interim monitoring, and close out)
  • May assist with co-monitoring at clinical trial sites, under the guidance of an experienced CRA; activities may include review of regulatory binder, subject data and pharmacy
  • Takes minutes at various meetings and distributes to the team. Actively participates in the meeting
  • Complies with all applicable policies regarding health, safety, and environmental policies

Job Requirements:

  • BA/BS in life sciences or related area and at least 3-5 years of experience in clinical trial administration; or equivalent
  • Working knowledge of FDA/ICH regulatory requirements for clinical trials
  • Understanding of the clinical trial process and can apply to site and study management
  • Outstanding organizational skills and detail oriented; ability to track detailed information
  • Demonstrated communication skills, including verbal, writing and interpersonal skills
  • Ability to identify issues and problems and make recommendations
  • Proficiency in Microsoft Word and Excel, PowerPoint and Adobe Acrobat. Working knowledge of EDC and CTMS systems

Job Type: Full-time

Experience:

  • clinical trial administration: 5 years (Required)

Education:

  • Bachelor's (Required)

Categories

Posted: 2019-05-15 Expires: 2019-06-14

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Senior Clinical Trial Associate

GlycoMimetics, Inc.
Rockville, Maryland

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