Senior Clinical Trials Associate

Bay Area or Raleigh-Durham Area /
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 an experienced Senior Clinical Trials Associate who is looking to join a remarkable company that cares about your professional growth? 
 
SUMMARY

ProTrials is seeking a Senior Clinical Trials Associate (Sr. CTA) to join us as a critical member of our Clinical Operations team.
 
The Sr. CTA acts as a pivotal teammate for the designated clinical study.  The Sr. CTA is engaged in the planning, implementation, and completion of clinical studies and will regularly interact with the study sites, vendors, sponsors, and study team.  The Sr. CTA also plays a part in accurately updating and maintaining the clinical systems. The Sr. CTA prepares, distributes, reviews, and archives clinical documentation and reports.
 
This role is a non-exempt, home-based position located in the Raleigh-Durham, NC area.

ESSENTIAL DUTIES

    • Sets-up and maintains the electronic Trial Master File (eTMF)
    • Assists with Quality Assurance (QA) eTMF review and general FDA readiness
    • Obtains, reviews, processes and tracks study related documents
    • Develops, maintains and disseminates multiple study trackers
    • Participates and supports sponsor audit activities
    • Manages and tracks investigational product supplies for study centers
    • Assists in preparation of materials for investigator meetings, monitor workshops, and study manuals
    • Assists Clinical Project Manager/Client in managing investigator meetings
    • Assists in creating and developing meeting agenda and minutes with project teams, sponsors, or vendors with minimal comments
    • Assists with vendor payments
    • Develops reliable relationships with Client/Sponsor and disseminates study related information to project team
    • Leads, trains, and provides support with the new CTA onboarding program

OTHER QUALIFICATIONS

    • Advanced understanding and demonstration of proficiency in CTA tasks
    • Experience setting up and maintaining eTMF
    • Proficient with study start up activities
    • Solutions oriented approach to problem solving
    • Professional and engaging communication and interpersonal skills
    • Remarkable Microsoft Word and Excel competency
    • Perform multiple tasks simultaneously and manage changing priorities
    • Ability to read and understand regulatory documents and Standard Operating Procedures

EDUCATION AND/OR EXPERIENCE

    • RN, Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
    • 2-3 years of prior experience as a Clinical Trial Associate preferred

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
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.