Senior Clinical Trial Associate

Gan & Lee Pharmaceuticals; New York (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Gan & Lee Pharmaceuticals USA Corporation seeks a Clinical Operations professional to support day-to-day management of clinical studies under the Head of Clinical Operations. The role will be based in either Denmark or the US, collaborating with the Clinical Operations Team to ensure quality and regulatory compliance.

The position requires a college degree or equivalent experience, 5+ years in global clinical studies, and strong skills in GCP/ICH, MS Office, and cross-functional collaboration.

Qualifications

• College degree in relevant field or equivalent years of direct industry related experience.
• At least 5 years of industry experience, with global clinical studies across phases.
• Strong communication, cross-functional collaboration, and adaptability.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

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; 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 and review Investigator Initiation Packets and Regulatory Documents for site initiation/investigational product release with CROs
• Create and maintain internal study activity trackers and study logs (e.g., Start-up, Regulatory Documents, Monitoring Visit Trip Reports, Enrollment Logs).
• Review vendor/Investigator site documents/plans for legibility and conformity to SOPs and protocol.
• Assist with start-up activities (e.g., informed consent documents).
• Create, file, track, QC, and archive the TMF and electronic study files.
• Track processing of Confidentiality, Consulting, and Study Agreements.
• Assist in processing and tracking invoices; ensure timely processing.
• Assist in maintenance of financial records/invoice tracker.
• Assist in monthly financial reconciliation against contracts.
• May serve as Data Retention Coordinator.
• Perform other duties as required.

Skills

Excellent communication skills

Cross-functional teamwork

Adaptable to changing priorities

MS Office proficiency

Multitasking and organizational skills

GCP/ICH/Federal Regulations knowledge

Process-oriented with attention to det

Self-motivated and proactive

Team player in fast-paced environment

Education

College degree in relevant field or equivalent

Job description

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.