Records Management Associate

Summary of the Position:

The Records Management Associate is responsible for supporting document management activities and the archival of clinical trial records for a project in the electronic Trial Master File (TMF).

Essential Functions:

  • Process study documents in accordance with client and study requirements as per study-specific processes, FHI Clinical’s SOPs/ADs and regulations, where applicable.
  • Complete activities related to document receipt and processing which may include but is not limited to:  document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
  • Maintain study trackers related to the TMF.
  • Liaise with study teams and other Document Management staff to fulfill job responsibilities and activities.
  • Provide information necessary to complete client and/or departmental status reports as requested by the management of the Document Management department.
  • Complete departmental projects as assigned in accordance with specified timelines, FHI Clinical’s SOPs/ADs and regulations.
  • Confirm all documentation meets ALCOA+ standards and FHI Clinical TMF criteria.
  • Inform the Manager of training issues, project activities, quality issues and timelines as directed.
  • Provide copies of study documents to FHI Clinical personnel as requested.
  • All other duties as assigned.

Knowledge, Skills and Abilities:

  • Must data entry experience. ExperiencceExperience with TMF (Trial Master File) and strong knowledge of Clinical Studies documents are preferred.
  • Strong computer skills (MS Office), SharePoint, and Acrobat.
  • Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
  • Ability to remain focused with regards to details.
  • Strong organization and planning skills.
  • Ability to work effectively under pressure of deadlines.
  • Outstanding client service skills.
  • Good oral and written communication skills and interpersonal skills.
  • Must be able to read, write and speak fluent English

Position Requirements:

  • Education: High School Diploma required
  • Preferred Job-Related Experience: 1-2 years of experience in an office environment and/or 6 months to 1 year of document management experience. Experience with managing clinical study documents using FDA, ICH, GCP guidelines and best practices pertaining to clinical trial document management and archiving. Prior experience working in a cross-matrix environment. Experience with clinical study electronic databases.
  • Additional Eligibility Qualifications: Technology to be used: Personal Computer, e-mail, telephone, printer, calculator, copier, cell phones, and other handheld devices. Strong computer skills (MS Office), SharePoint, Acrobat and ability to work in FHI Clinical databases. Ability to format and publish large documents and create and maintain tracking systems and spreadsheets. Ability to coordinate review and finalization of documents with multiple stakeholders

Physical Expectations:

  • Typical office environment.
  • Ability to sit and stand for extended periods of time. 
  • Ability to lift 5-10 lbs

Travel Requirements:

  • The expected travel time is less than 10 % for this position.

APPLY HERE