Documents Specialist I

Documents Specialist I Position Summary:

The Documents Specialist I is responsible for site, country and contact creation within the eTMF system, as well as performing document QC / indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.

Essential functions of the job include but are not limited to:

• Perform document QC and indexing within eTMF for assigned studies
• Add Countries, Sites and Site contacts as required per assigned study
• Perform data entry and reconciliation in various clinical systems and tracking tools
• Follow-up on document in clarification and ensure these are resolved timely

Qualifications:

Minimum Required:

• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline
• Prior study support experience or proven competencies for this position

Other Required:

• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
• Ability to speak English proficiently (professional level)
• Electronic TMF experience preferred

Competencies:

• Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Demonstrates solid interpersonal skills
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles