Clinical Trial Associate
San Jose, CA | Direct Hire
Bayside Solutions is seeking a Clinical Trial Associate to be part of our Client’ s team in the South Bay. This is an opportunity to work with a local organization focused on the movement of new drugs or devices from conception to FDA approval.
The Clinical Trial Associate will be a crucial contributor to the Clinical project teams. Someone with working knowledge of clinical trial documentation, eTMF/TMF, and strong experience with study start-up, maintenance, and close-out would be ideal for this role. Individuals who are passionate about their long-term growth within an organization and have a proactive mindset would be a great fit for this team.
Our Client’ s culture is founded on core values that keep them committed to being a collaborative, innovative, honest, and adaptable place to work. They have built a family within the workplace, promote employees from within, provide opportunities for professional development, and encourage their employees to be active in their efforts to impact their surrounding communities. This has ultimately created an ideal work environment where you can have a fulfilling and balanced career in clinical research.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join an organization focused on the movement of new drugs or devices from conception to FDA approval.
- Work for a company that is local to the beautiful south bay area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, vacation/PTO, and 401K.
Summary of Responsibilities:
- Set-up, manage, and maintain the Trial Master File (TMF).
- Obtain, review, process, and track study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).
- Create meeting agenda/minute templates and provides drafts of meeting minutes.
- Receive and prepare requests, ship and return Investigational Product supplies.
- Prepare, ship and manage inventory of study related supplies.
- Manage and track investigational product supplies for study centers.
- Gather investigator and site information (addresses, phone numbers, fax numbers, personnel names and email addresses, etc.).
- Assist in preparing materials for investigator meetings, monitor workshops, and study manuals.
- RN or B.S. and/or advanced degree in biological sciences or related field or equivalent combination of relevant experience, education or training and previous CTA experience.
- Strong attention to detail and excellent organizational skills.
- Advanced proficiency in Microsoft Word and Excel.
- Willingness to work at the office or at a client' s place of business.
- Ability to efficiently perform multiple tasks and manage changing priorities.
- Ability to identify and solve logistical problems.
- Ability to read and understand regulatory documents and SOPs.