Clinical Quality Associate

Target Pay Rate: 35-40/hr **salary will be commensurate with experience

Job Description:

Essential Duties and 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.

Qualifications:
· 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.

Education and/or Experience:
- 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