Senior Clinical Trial Associate
Summary
Oversee day-to-day management of global clinical trials, ensuring GCP/ICH compliance and coordinating study documentation, vendor agreements, and site start-up activities.
Summary
This position reports to the Head of Clinical Operations, Gan & Lee Pharmaceuticals USA Corporation or designee. This role is responsible for working side-by-side with the Clinical Operations Team, assisting with day-to-day management of clinical studies. The position will be based in either Denmark or US.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
Under supervision and in accordance with all applicable federal, state and local laws/regulations (including local/regional regulations outside US, as required), GCP/ICH guideline, and the Company’s policies, procedures, and guidelines, this position is responsible for the following:- 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.