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