Project Assistant (Remote) Jobs

Advantages Of Joining Employer

• Develop proficiency in databases and programs.
• Contribute to impactful research in the pharmaceutical/biotech or device industry.
• Gain experience in managing clinical trials.
• Supportive and collaborative clinical project team.
• Opportunity to work remotely from anywhere.

• Maintain confidentiality and sensitivity inside and outside the company.
• Ensure study documents meet FDA/ICH/GCP guidelines.
• Utilize databases and programs effectively.
• Attend and record minutes for internal and external clinical meetings.
• Collect and prepare information for discussions/meetings.
• Review site regulatory documents for compliance with ICH GCPs and FDA guidelines.
• Track study-specific training at site and facility level.
• Track employer's corporate review and approvals for study conduct at facilities.
• Communicate effectively with internal and external personnel, clients, and vendors.
• Liaise with internal data management team to troubleshoot data issues.
• Provide recordkeeping and reporting for investigator payments.
• Provide administrative support, including document preparation and scheduling.
• Maintain clinical project files to internal standards and regulatory requirements.
• Assist with the development of tools for use across studies.
• Establish and maintain trial master files in compliance with SOPs, ICH, and GCPs.
• Provide solutions to project questions and issues.
• Create and maintain study tracking documents.
• Prepare, track, and review patient payments.
• Support specific projects assigned by the supervisor.
• Contribute to the preparation of presentations and reports.
• Perform assignments requiring research and initiative.
• Drive issues to closure and maintain a positive attitude.
• Maintain sponsor/study-required databases.
• Follow established company policies and procedures.
• Collect patient enrollment data and flag appropriately in the employer's systems.
• Track and assist with study start-up activities.
• Provide project management support for timelines, reporting, and technical requirements.
• Track SVP review and approvals for study conduct at sites.
• Develop and implement study-related materials and coordinate distribution to sites.
• Collect study documents from investigative sites and prepare submissions for review boards.

Additional Information

• Availability outside of office hours may be required.
• Travel may be required up to 10%.
• This is a 100% remote position.
• Employer maintains a drug-free workplace in accordance with applicable laws.

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