Clinical Project Associate
6 months ago
**We are Growing** Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.
Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.
Start your career journey at Biorasi today with our newest opportunity -** Clinical Project Associate**
**Responsibilities**:
- Communication: Partake in meetings/teleconferences. Develop and distribute meeting agendas, minutes, monthly status reports, and action item distribution and tracking to document key project updates and communications to relevant stakeholders, as requested.
- Site Management: Assist with the development of sites budgets, contracts and payments administration.
- Study Start-up: Support Clinical Trial Managers and Project Managers in the development of project plans and documents required for site feasibility, selection, and activation.
- Site Activation: Coordinates with the project team in retrieval and review of regulatory documents required for initiation of a clinical trial. Perform preliminary review of IP release form prior to CTM or Sponsor approval.
- Document Management: assist and help drive project team in the collection, review, filing, and archival of essential documents, and maintenance of the Trial Master File.
- Supplies Management: Coordinate logistics of the project, including printing of study tools and materials, securing study supplies, helping with the distribution, tracking and collection of study supplies and materials. Track clinical supplies at the site level in coordination with established study systems.
- Study Management: Assist project team members to create and maintain project trackers, relevant systems (e.g. CTMS, study portal) routine correspondence messages and distribute to project team, Sponsor, sites and other stakeholders based on relevance.
- Vendor Management: Assist with the vendor identification, qualification, selection and management throughout a clinical trial, including administration of vendor payments.
- Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Assist the Project team in the resolution of audit findings; assist project team in review and maintenance of clinical trial documentation for audit readiness.
- Participate in the review of clinical data or reports generated from clinical database; assist the team in data cleaning efforts
- Assist with financial reconciliation tasks
- Participate at client presentation meetings and Investigator Meetings (IM) as necessary.
- Communicate any out of scope issues to upper management as soon as identified.
- Assist the study teams in meeting timelines
- Exhibits ability to perform CPA work with mínimal support from CTMs and PMs on their assigned projects
- Other duties as assigned.
- Associates or Bachelor’s degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field
- Fluent English (oral and written) and applicable local business language.
- Clinical research experience required. Prior experience as a study coordinator and/or regulatory coordinator preferred.
- Knowledge and understanding of ICH GCP and applicable local regulatory requirements
- Solid understanding of essential documents and ability to review them for completeness
- Excellent verbal and written communication skills.
- Excellent organizational, multi-tasking and time management skills required.
- Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint, and Excel)
- Effective business skills for interactive situations with peers, sites, and clients.
We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off to include vacation, holidays, and sick days, medical, dental, vision, life insurance, short-term and long-term disability, company matching 401K, employee bonus programs, career growth, training and development.
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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