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Company

ClinChoice · 5 hours ago

Technical Document Operations Specialist

United States

Full-time

Remote

Entry Level

1+ years exp

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Responsibilities

Assist Essential Document Manager in the maintenance of the Trial Master File.

Process applicable emails within the Site Initiation, Clinical Clearinghouse, Technical Document Operation Specialist USA inquiries and Restricted Mailboxes in accordance with the TMF Master List.

Facilitate the archiving of Trial Master File documents received from other companies, including the review of inventory spreadsheets and DVDs/CDs/USBs/Hard Drives received from other companies.

Follow Up with CRO and the Record Center as needed throughout the process to ensure documents are archived appropriately and in a timely fashion.

Safety Report processing.

Recall study documentation from archive as needed, review contents as instructed, and return study documentation to archive in a timely fashion.

Ongoing REDS>TMF Reconciliation.

Audit and Inspection support, as needed.

Site Binders: General template preparation prior to clinical team review.

Study specific binder template negotiation with clinical team.

Physical creation of binder(s) per site or submission.

Preparation and submission of Revision packages.

User Acceptance Testing, as requested.

Attend meetings with Essential Document Management and/or clinical teams, as needed.

Maintain binder and document processing metrics and tracking.

Unblinded document processing.

Assist with Merger & Acquisition related tasks, including meeting attendance.

Address Legal requests, as needed.

Assist with Site Retention related tasks.

Processing documents to Vault.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical ResearchEssential Clinical Trial DocumentationETMFAdobe AcrobatMicrosoft Office Suite

Required

High School Diploma required

1 year of experience working in Clinical Research

Must have knowledge of 'Essential' Clinical Trial Documentation

Strong verbal, written and organizational skills with a team-oriented approach as well as works well independently

Strong time management skills

Detail oriented

Self-motivated

Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment

Excellent English communication skills (oral and written)

Proficient in Adobe Acrobat and Microsoft Office Suite, including (but not limited to) Word, Excel and Outlook

Preferred

Bachelor’s degree preferred

Familiarity with electronic Trial Master File system preferred

Company

ClinChoice

Glassdoor

3.7

ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.

Founded in 1995

Shanghai, Shanghai, CHN

1,001-5,000 employees