Note: The job is a remote job and is open to candidates in USA. Gan & Lee Pharmaceuticals is seeking a Senior Clinical Trial Associate to support its Clinical Operations Team. The role assists with the day-to-day management of global clinical studies, including study administration, regulatory documentation, vendor coordination, financial tracking, and Trial Master File maintenance.
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
Skills
- College degree in relevant field or equivalent years of direct industry related experience
- At least 5 years of industry or equivalent experience
- Working with global clinical studies in different study phases
- 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
Company Overview