Quality Control Associate - Clinical Research

The Quality Control Associate will be responsible for ensuring source documents are quality control reviewed and compliant with study and non-study regulations including, but not limited to, the study Protocol, HIPAA, OSHA, Good Clinical Practice (GCP), Good Documentation Practice (GDP), Case Repot Form (CRF), ICH Guidelines, Site Standard Operating Procedures (SOP) and Work Instructions (WI). ?

WCCT Global, LLC is a pharmaceutical contract research organization that offers outsourced early drug development and late phase services to pharmaceutical, biotechnology, and medical device industries worldwide.?We are proud to?offer services in the areas of cardiovascular, gastrointestinal, infectious disease and vaccines, ophthalmology, respiratory, and immunology and allergy. WCCT Global, LLC was formerly known as West Coast Clinical Trials, LLC.?We were?founded in 1998 and?are based in Cypress, California

PLEASE NOTE: This position requires working onsite, at our Cypress, Ca. headquarters location; this is not a remote position. Local candidates are preferred however, you may choose to relocate at your own expense.

Essential Job Functions?

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* Adhere to the established SOP and WI when performing quality control review.
* Knowledge of all awarded Protocols and applicable supporting manuals (i.e. pharmacy, lab, ECG,?etc.) to perform quality control review.
* Perform quality control review of completed source documents and other select materials and?ensure compliance with all study and non-study regulations including, but not limited to, the?study Protocol, HIPAA, OSHA, GCP, GDP, CRF and ICH Guidelines.
* Participate in study related meetings including, but not limited to, study award meetings,?planning meetings, Protocol training, and site initiation visits.
* Read and understand each assigned Protocol.
* Adhere to project work plans and revisions as appropriate to meet any change in needs and?requirements.
* Maintain an open line of communication on daily and weekly basis with team and other?department members.
* Escalate any critical or major findings or trends to the Quality Management System (QMS) Team?and applicable Study Team.
* Interact with Clinical Research Associates at scheduled monitoring visits to improve?understanding of quality issues

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Qualifications?

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Education

* Bachelor?s degree preferred, or combination of education and experience

Experience/Training

* Minimum 1 year working in clinical research or related field required
* Previous experience working in Quality Assurance or Quality Control preferred
* Previous experience in CAPA management preferred
* Familiarity with ICH GCP/GDP guidelines?

Certifications

* C-CRP (preferred)
* Six Sigma Green/Black Belt (preferred)
* Affiliation/certification of Quality Organization such as: ASQ (preferred)?

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Physical Requirements & Working Conditions?

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The description of the physical demands and the work environment characteristics here represent those

that must be met by an employee to successfully perform and those an employee encounters while

performing the essential functions of this position. ?Reasonable accommodations may be made to enable

individuals with disabilities to perform the essential functions.?

While performing the duties of this job:?

1. Ability to talk or hear.?

2. Required to sit 90% of the workday.?

3. Occasionally required to stand; walk.?

4. Must be able to use hands to finger, handle, or feel; reach with hands and arms.?

5. Minimal lifting is required, 10 pounds, with assistance and/or move up to 50 pounds.?

6. Specific vision abilities required by this job include close vision, color vision, and ability to adjust

focus when viewing a computer monitor.

7. While performing the duties of this job, the employee is occasionally exposed to moving

mechanical parts, fumes or airborne particles, toxic or caustic chemicals and risk of electrical?

shock. ?

8. The noise level in the work environment is usually low.?

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