Clinical Trials Associate

San Jose, CA /
Clinical Operations /
Full Time
We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity.  Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.
 
What fuels our focus?  Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones.  We show up every day committed to do work that matters.  When you join ProTrials, you will join a collaborative community helping to build a healthier world. 
 
We also understand your need to balance a meaningful workload with life’s every-day moments.  At ProTrials, we know that this makes our employees happier, healthier, and more successful.  

Are you a highly motivated Clinical Trials Associate who is looking to join a remarkable company that cares about your professional growth? 
 
SUMMARY
ProTrials is seeking a Clinical Trials Associate (CTA) to join us as a crucial contributor to Clinical Operations team.
  
The CTA acts as a central contact for the designated clinical study team.  The CTA is an active partner in the planning, implementation, and completion of clinical studies through interaction with sites, vendors, sponsors, and team members.  The CTA also assists with accurately updating and maintaining the clinical systems. The CTA participates in preparing, distributing, reviewing, and archiving of clinical documentation and reports.
 
This position is based in the ProTrials Headquarters located in downtown San Jose, CA.

ESSENTIAL DUTIES

    • Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
    • Sets-up and maintains the Trial Master File (TMF/eTMF)
    • Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, and budget disbursements
    • Attends and takes meeting minutes for the internal team and Sponsor meetings.
    • Manages and tracks investigational product supplies for study centers; receives and prepares requests, ships and returns investigational product supplies
    • Prepares, ships and manages inventory of study related supplies
    • Gathers investigator and site information
    • Assists in preparing materials for investigator meetings, monitor workshops, and study manuals
    • Creates meeting agenda/minute templates and provides drafts of meeting minutes
    • Communicates effectively with members of the ProTrials project teams, interfacing directly with sponsor as directed by Project Manager (PM), in a collaborative manner
    • The CTA may work at the ProTrials Corporate office or at a client’s place of business

OTHER QUALIFICATIONS

    • Ability to identify and solve logistical problems
    • Excellent communication and interpersonal skills
    • Effective organizational skills and a high regard for attention to detail
    • Ability to efficiently perform multiple tasks and manage changing priorities
    • Demonstrate proficiency in Microsoft Word and Excel
    • Ability to read and understand regulatory documents and Standard Operating Procedures

EDUCATION AND/OR EXPERIENCE

    • RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CTA experience.

PERKS AND BENEFITS

    • Competitive pay
    • Career growth
    • Full medical, dental, and vision benefit packages
    • 401(k)
    • Commuter benefits
    • Legal benefits
    • The best coworkers, if we do say so ourselves
Thank you for considering joining the ProTrials team.

ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.