Documentation Specialist job in Boston, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Project/Study Manager (CSM/CPM)

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

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