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GEHC - Clinical Specialist I
Ref No.: 18-24703
Location: Marlborough, Massachusetts
Position Type:Contract
Start Date / End Date: 05/07/2018 to 05/06/2019
Job Description:
Job Title: Clinical Specialist
Job ID: GEJP00018930
Location: Marlborough, MA
Duration: 12 months Contract, extension if needed
 
Key responsibilities:
  • Assist the GxP Operation team with the inspection readiness of TMF/eTMF records for clinical studies; work with internal staff as necessary for document reconciliation
  • Assist the archivist with tracking and transfer of paper records to off-site archives for permanent storage
  • Assist with retrieval and return of legacy Clinical Trials documentation at offsite storage facilities
  • Assist with management of TMF regulatory documents associated with clinical supplies. Work closely with Client Clinical Support Analyst and vendor to assure filing of documents into TMF/eTMF.
  • Perform scanning of clinical trial and training documentation for electronic filing and storage.
 
Quality Specific Goals:
  • Awareness and compliance with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
  • Completion of all planned Quality & Compliance training with the defined deadlines. Identify and report any quality or compliance concerns and take immediate corrective action as required.
  • Participation in continuous improvement activities by driving the implementation of process quality improvement initiatives when possible.
 
Qualifications/Requirements:
  • 0-2 years experience in clinical trials management and systems management within the pharmaceutical biotech or healthcare industry.
  • Excellent communication and interpersonal skills and ability to work in a team.
  • Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
  • Must be willing to work in our Marlborough, MA office.
 
Desired Characteristics:
  • Prior knowledge of the clinical trials process and Good Clinical Practices.
  • Well organized and structured, attention to detail.
  • Able to work independently and systematically on multiple tasks.
  • Diplomatic, cooperative team worker.
  • Ability to prioritize assignments and deliver according to defined milestones & multiple projects.
  • Able to work well independently as well as function as a cohesive member of a team.
  • Proficient with Microsoft Word and Excel.
  • Strong attention to detail and understands importance of timelines; strives to adhere to and meet deadlines.
Thanks & Regards,
Afifa.B
Associate Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.507.7557
Email: Afifa.B @artechinfo.com | Website: www.artechinfo.com