Summary

Education and Credentials

• College degree in relevant field or equivalent years of direct industry related experience.

Experience

• At least 5 years of industry or equivalent experience.
• Working with global clinical studies in different study phases.

Skills

• Must have good communication skills (both oral and written).
• Ability to work in cross-functional team.
• Willingness to adapt to changing priorities and assignments.
• Familiarity with Microsoft Suite of applications including Word, Excel, Project, and PowerPoint.
• Efficient, organized, and capable of multitasking.
• Working knowledge of GCP standards, ICH, and Federal Regulations.
• Process oriented with a strong attention to detail.
• Self-motivator.
• Team player who thrives in fast-paced environment.

Responsibilities

• Ensure quality and compliance in all actions by attending GCP training as designated and appropriate for role.
• Adhere to company policies and procedures.
• Exercise the highest level of integrity at all times.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time.
• Participate in the planning, organization, and follow-up of meetings as needed.
• Review meeting materials for accuracy, completeness, clarity, legibility, and typos.
• Prepare and/or update slides.
• Provide administrative support, as needed, to Study Team.
• Participate in study team meetings (planned and/or on an ad hoc basis); produce and track internal meeting agenda, minutes, and action items when necessary.
• Maintain study contact lists, updating internal and external vendor contact information, as needed.
• Compile, distribute, collect (for some studies), and review for completeness, Investigator Initiation Packets and Regulatory Documents required for site initiation/investigational product release in collaboration with CROs 
• For some studies, create and maintain internal study activity trackers and study logs, (i.e., Study Site Start-up, Regulatory Documents, Monitoring Visit Trip Reports, Enrollment Logs, etc.).
• Review vendor/Investigator site documents/plans (e.g., monitoring plan) for legibility, typographical errors, and conformity to available source documentation (i.e., applicable SOPs, study protocol, etc.).
• For some studies, assist with start-up activities (i.e., development of informed consent and other study related documents).
• Create, file, track, QC, and archive the TMF, including filing and maintenance of electronic study files, as needed, as well as general study materials.
• Track the processing of Confidentiality, Consulting, and Study Agreements.
• Assist in processing and tracking investigator/vendor invoices; ensure invoices are processed in a timely manner.
• Assist in the maintenance of financial records/invoice tracker.
• Assist in performing monthly financial reconciliation against vendor/external partner contracts.
• May serve as Data Retention Coordinator in alignment with company policy.
• Perform other duties as required.