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Specialist, Trial Master File in Cambridge, MA at Integrated Resources, Inc

Date Posted: 1/11/2019

Job Snapshot

Job Description

Job Title: Specialist, Trial Master File
No. of Positions: 1
Duration: 12 months
Pay rate: $35/hour
Location: Cambridge, MA

Duties:
  • This position is responsible for the appropriate scan, index, quality check, file, archival and retrieval of records for the Clinical Operations' section of the Trial Master Files (TMF).
  • This individual will provide expertise in record management and archival support for Clinical Operations, including but not limited to the safekeeping and accessibility of Clinical Operations' Trail Master File records for all Alnylam sponsored clinical studies by ensuring records are appropriately and securely filed and archived.
  • This position is responsible to support the definition, implementation, execution and process improvement of storage activities for both active and inactive studies.
  • The TMF Specialist or the named GCP Archivist oversees management of correct archiving procedures within Alnylam in accordance with company policies, operating procedures, GCP, federal policies and any other contractual obligation.
  • Set-up Clinical Operations' paper folders, as applicable
  • Process Clinical Operations' administered TMF records: scan, index, quality check and file against pre-defined quality criteria and in compliance with service levels
  • Manage Clinical Operations' administered TMF inventory trackers
  • Resolve Clinical Operations' administered TMF-related queries or quality issues by working closely with study teams
  • Ensure completion and accurateness of Clinical Operations' administered TMF at all times and provide advice to study teams with respect to the filing of TMF records
  • Support Clinical Operations' administered TMF review process by working closely with study teams
  • Preform assigned TMF review actions in a timely manner
  • Support Clinical Operations' preparation for a TMF audit or inspection (i.e. inspection readiness)
  • Prepare for receipt of CRO's portion of the TMF
  • Process the CRO's portion of the TMF in a timely and controlled manner in accordance with procedures
  • Prepare Clinical Operations' administered TMF records for long-term, off-site archival in compliance with company and expertise area controlled procedures and GCP
  • Archive Clinical Operations' administered TMF records in a timely and controlled manner in accordance with procedures
  • Retrieve Clinical Operations' administered TMF records from long-term, off-site archival
  • Perform quality checks and test retrievals of Clinical Operations' administered TMF records from long-term, off-site archival; document any findings and follow to resolution or escalation in compliance with company and expertise area controlled procedures and GCP
  • Support and train Clinical Operations' team members on correct archival procedure of Clinical Operations' administered TMF records
  • Continuous assessments of Clinical Operations' record management work practices in order to maximize efficiency; communicate to management any improvement suggestions
  • Participate in independent audits of external archive facilities, as applicable
  • Control access to Clinical Operations' administered TMF records, filed or archived, in accordance with defined procedures
  • Manage, track and document TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies

Skills:
  • Excellent interpersonal skills
  • Detail-oriented with strong organizational skills
  • Skilled in Microsoft Excel, SharePoint and Word
  • Ability to multi-task, be flexible, and thrive in a fast-paced team environment
  • Ability to handle a high volume of complex tasks within a given timeline
  • Ability to work in a team environment as well as independently

Education:
  • Bachelors degree recommended

Required Skills:
  • ARCHIVING
  • CLINICAL OPERATIONS
  • CLINICAL STUDIES
  • GCP
  • OPERATIONS

Additional Skills:
  • PROCESS IMPROVEMENT
  • AUDIT
  • AUDITS
  • CRO
  • DETAIL-ORIENTED
  • EXCEL
  • FILING
  • INVENTORY
  • MICROSOFT EXCEL
  • MICROSOFT SHAREPOINT
  • MICROSOFT WORD
  • ORGANIZATIONAL SKILLS
  • QUALITY CHECKS
  • SHAREPOINT
  • WORD

Languages:
  • English
  • Read
  • Write
  • Speak

Minimum Degree Required: Completed High School (Diploma or GED)