Senior Clinical Trials Associate

2 weeks ago

Durham, United States CareerBuilder 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 lifes 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
This position's pay range is $65-95k/year.

PERKS AND BENEFITS

Competitive pay
Career growth
Full medical, dental, and vision benefit packages
401(k) with match
Commuter benefits
Legal benefits
The best coworkers, if we do say so ourselves
Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicants personal information in accordance with its statutory obligations and internal policies and procedures.
Information collected during application completion may be retained for a reasonable period of time and in accordance with the companys established retention policies. Applicants seeking more information may contact

HR@ProTrials.com .
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.

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