ESSENTIAL FUNCTIONS:

• Ensures records of medical monitor contacts are archived in the Trial Master File.

• Supports study-related committees and meetings between sponsor and SYNH medical experts by attending meetings, preparing meeting minutes, and maintaining archiving all related documents.

• Uploads and manages documents collected for pre-enrollment review and endpoint adjudication into systems, including the Trial Master File

• Physician and Scientist staff with documentation and archival of their deliverables and TMF-relevant correspondence
• Ensures receipt and direction of laboratory and vendor alerts to the appropriate physician, and follows the alert to ensure site outreach and archival of site correspondence.

• [SAS] May Assist Medical Affairs Scientists with review of medical data listings, Case Report Form (CRF) line and lab listings, and medical coding in support of Scientific Review duties.

• Ensures compliance with the Code of Federal Regulations (CFR), HIPAA, state regulations, International Committee on Harmonization (ICH), and GCP guidelines, and sponsor Standard Operating Procedures (SOPs), and Work Instructions (WIs), where appropriate.

REQUIREMENTS:

BA/BS in the biological sciences or related discipline in the natural sciences/health care field, nursing degree, or equivalent combination of education and experience. Solid office/administrative experience. Nominal clinical research or medical clinic/hospital experience preferred. Good knowledge of ongoing protocol and disease related terminology and the drug development process, including database and medical terminology. Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Strong customer service skills with effective written and verbal communication appropriate to a professional medical setting. Strong organizational, presentation, documentation, and interpersonal skills, as well as a team oriented approach. Excellent verbal, written, and communication skills. Ability to multitask to meet tight deadlines in a dynamic environment while providing attention to detail and high quality work.

This job exclues CO applicants.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.