CTA
Summary
This position reports to Clinical Operation Director, 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.Education and Credentials
- College degree in relevant field or equivalent years of direct industry related experience.
Experience
- At least 3 - 8 years of industry experience.
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:- Participate in study team meetings (planned and/or on an ad hoc basis)， support in the planning, organization, and follow-up of meetings as needed, and produce and track internal meeting agenda, minutes, and action items when necessary.
- Compile, distribute, collect (for some studies), and review for completeness, Investigator Initiation Packets and Regulatory Documents required for site initiation/investigational product release.
- 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.
Recommended Jobs
AWS Software Engineer III - Python/Data Pipeline
Job Description We have an exciting and rewarding opportunity for you to take your software engineering career to the next level. As an AWS Software Engineer III - Python/Data Pipeline at JPMor…
Technician
Job Title: Technician Location: New Brunswick (NB) Department Name: Physical Therapy Req #: 0000237538 Status: Hourly Shift: Day Pay Range: $20.24 - $29.33 per hour Pay Transparenc…
Executive Director
🌎 Change the world. Get paid for it . At Acumen, we’re on a mission to help the disabled, military veterans, and the elderly live more independent, empowered lives. If you want your work to matte…
Pallet Builder
Job Title: Warehouse Worker Job Description Seeking a warehouse and crate builder candidate. This job is considered a hybrid role in the the warehouse. Worker will be assembling pallet crates f…
Director, Engineering
Description Position at WebMD WebMD is the most recognized and trusted brand of health information and the leading provider of health information services, serving consumers, physicians, healthc…
Business Development Specialist
Overview Responsible for directing, conducting, and implementing business development consistent with corporate plans and strategies. Special concentration on motivational, technical, sales, custo…
Associate Principal Scientist (Associate Director) - Outcomes Research
Job Description Role Summary Under the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for planning/managing real world and econom…
UAV Pilot I
Join a Leading UAV & Geospatial Services Company! SURVAIR is a technology-driven aerial data and geospatial services company specializing in Unmanned Aerial Vehicle (UAV) operations, mapping…
Creative Strategist
We’re on the hunt for a visionary Creative Strategist to join our Brand Partnerships team and take our partnership work to exciting new heights. As our Conjurer of Creative Strategies, you’ll bridge…
Senior Project Manager - Commercial Solar
Senior Project Manager – Commercial Solar Location: Hawthorne, NJ Country: United States Salary: $125K - $155K Start Date: Description: About the Company We are a nationally rec…