ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Clinical Trial Assistant (CTA) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.
PRIMARY DUTIES & RESPONSIBILITIES:
- Work cross-functionally with the study teams internally and externally
- Collaborate with the study team to develop study-related materials, trackers, and tools
- Prepare study-related materials for the training of internal and external staff
- Works within multiple company systems to create, or compile data, for reporting and metric purposes (i.e., eTMF, CTMS, legal web site, etc.)
- File, track and maintain the Trial Master File (TMF)
- Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs/CDAs) and/or site-specific budgets between the legal team and study sites
- Review site-specific regulatory packets for completeness and accuracy
- Assist sites and/or Clinical Research Organization (CRO) with study supplies management
- Prepare and distribute Investigator Site Files (ISFs)
- Track site payments and vendor invoices
- Conduct study closure activities (sites status, reconciliation activities, filing & archiving)
- Assist with meeting coordination, meeting materials and meeting minutes
- Track and collate clinical trial documentation related to Clinical Study Report (CSR) appendices, as needed
- Support quality review of electronic Case Report Forms (eCRFs), eTMF and other study-related activities
Knowledge, skills & abilities:
- Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
- Good interpersonal/communication skills
- Excellent written and verbal communication skills (English).
- General knowledge of computers and navigating databases
- Well organized, team-oriented individuals encouraged to apply
- Proficient in Microsoft Office suite (Word, Excel, PPT)
- Ability and willingness to travel 25% of the time (post-pandemic).
- Driven to make a positive impact in cancer diagnosis and treatment.
- Bachelor’s Degree in biology-related field or equivalent healthcare or laboratory-related work experience
- At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) is preferred
All candidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***