Documentation Specialist

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Project/Study Manager (CSM/CPM)
  3. United States
Boston, USA
Posting date: 06 Oct 2020

Proclinical is currently recruiting for a Documentation Specialist with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

  • Expert in the creation and maintenance of Clinical documents like protocol, amendments, summary of change documents, ICFs. CSRs. SAE narratives. patient summaries etc.
  • Responsible for supporting Clinical Trial document control through-out the conduct of a study.
  • Coordinates the approval of documents and distribution of sponsor documents to the CRO.
  • Supports study teams around business process needs such as Investigator meetings/Kick -off meetings/vendor coordination meeting.
  • CDA generation.
  • Safety letter tracking, Insurance procurement. DMC documentation.
  • Reference manager, Starting Point templates. CSR appendix generation.
  • Patient safety cards and printing.

Skills and Requirements:

  • Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.