- 214870 - Clinical Quality Associate
- Industry
- PRO
- Region
- IL-Illinois
- City
- Deerfield
- State
- IL
- Rate
- Up to $46.15 DOE
- Duration
- 12 months
- Description
- Chipton Ross is seeking a Clinical Quality Associate for a contract opportunity in Deerfield, IL.
BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
· Familiarity with the U.S. regulations, international regulations and standards related to
clinical research, especially ICH E6 GCP and ISO 14155
· Attention to detail, for quality when reviewing documentation, and ability to work effectively both as an independent contributor and as a member of the team are expected for this position.
· Work well within cross-functional teams to communicate needs, obtain information and
provide advice regarding accurate clinical trial documentation.
· This position requires familiarity with and ability to proficiently utilize clinical trial software including eTMF and Clinical Trial Management Systems (CTMS) software
· Excellent verbal and written communication, interpersonal and organizational skills are required.
· Ability to maintain effectiveness under changing circumstances and priorities.
· Must be able to expand knowledge and adapt to an increasingly complex environment.
- Bachelor's degree required.
- 2 + years' relevant work experience in working in clinical study research and being involved with the development of pharmaceuticals and/or medical device products.
- Must have at least 2 years' experience working with clinical documentation, utilizing a trial master file, and generation and oversight of essential documentation.
- Experience liaising with Quality for documentation accuracy and ability to adhere to SOPs
POSITION RESPONSIBILITIES:
· Perform filing and maintenance of essential documents associated with client clinical
research trial master file (TMF) in compliance with procedures and standards.
· Support System Administrators for electronic Trial Master File (eTMF) and Clinical Trial
Management System (CTMS) maintenance of the systems.
· Conduct study record assessments, quality checks and perform reconciliation of the TMF
documentation for in house and outsourced studies and provide recommendations and
instructions to CRO counterparts to correctly complete the TMF in a timely fashion.
· Collaborate with various internal and external groups (Data Management, Statistics, CROs, study/site managers, Quality, Regulatory, IT) to obtain and provide oversight of
documentation supporting compliance of a clinical trial.
· Support aspects of audit-readiness activities regarding preparation and staging of clinical
trial documents
· Participate in project teams as an extended team member by advising CPM and CRAs
about completion of essential documentation and adherence to company SOPs.
REQUIRED EDUCATION:
Bachelor's degree required
WORK HOURS:
First shift, Full Time
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Contact
-
Silmese Graves
sgraves@chiptonross.com
CHIPTON-ROSS, INC.
11832 Fishing Point Drive, Suite 100
Newport News, VA 23606
Phone: (757) 595-0005 x261 or (877) 244-5418 x261
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.