Clinical Trials Associate

San Jose
Clinical Operations
Full-time
ProTrials Research, Inc. has been in business for 23 years and is dedicated to providing the clinical research industry worldwide with professional services that demonstrate the highest level of experience, quality, and integrity while assuring career growth and job stability for its employees.

SUMMARY

The Clinical Trials Associate (CTA) is an employee of ProTrials Research, Inc., supporting Clinical Research team members. The CTA shall work well under pressure, and meet multiple and sometimes competing deadlines. The CTA shall at all times demonstrate cooperative and professional behavior with colleagues, clients and supervisors in compliance with the Standards of Professional Conduct.  The CTA should be able to show flexibility with changing project-specific priorities. The CTA will support and provide administrative assistance by performing all or some of the tasks listed below. Other tasks or responsibilities may be assigned as deemed necessary.


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.


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).
    • Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, and Budget Disbursements.
    • 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 (addresses, phone numbers, fax numbers, personnel names and email addresses, etc.).
    • 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 tasks or responsibilities as assigned.

OTHER QUALIFICATIONS

    • Attention to detail.
    • Excellent organizational skills.
    • Effective communication and interpersonal skills.
    • Ability to efficiently perform multiple tasks and manage changing priorities.
    • Ability to identify and solve logistical problems.
    • Ability to work effectively on a diverse team.
    • Ability to read and understand regulatory documents and Standard Operating Procedures.
    • Demonstrate proficiency in Microsoft Word and Excel.
    • Take direction well.
    • Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.   
    • Must have availability of a car in good condition, a valid driver's license, a good driving record, and up-to-date car insurance.

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.