Regulatory Job Audit Specialist

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Audit Specialist PA Open (J#23078)
Experience: 1 - 3 years

Senior Clinical Quality Assurance Associate with GCP experience

With minimal management oversight the qualified candidate will be responsible for:
Professional communication with Encorium and Sponsor study team members
Ensuring set-up and maintenance of the QA Central File (department and project-specific)
Participating/Conducting all applicable QA activities (i.e. Audit Plan, ICF reviews, site audits, database audits, CSR audits to ensure compliance to applicable regulations., Encorium Procedures and ICH/GCPs.
Assisting in the identification of areas and/or individuals that require additional training and ensure appropriate training sessions are conducted (i.e. audit observations).
Assisting in providing Good Clinical Practice (GCP) training to Encorium, and/or Sponsor, investigative site, personnel through presentations and meetings, as applicable.
Assisting in the development, implementation and training of QA Procedures and other Encorium Procedures.
Responsible for providing training, mentoring and support to QA and/or Encorium personnel, as appropriate.

The qualified candidate MUST have the following minimum requirements:
Bachelors degree in a life science/related area (e.g. biology; chemistry) with 4 or more years of clinical research experience and 3 or more years recent auditing (preferred) or monitoring experience.
Demonstrated expertise in Quality Assurance procedures, through knowledge of the drug development process, FDA regulations and guidance documents, ICH guidelines, strong oral and written skills, effective problem-solving skills and ability to orchestrate multiple activities at one time. International experience a plus.
Experience with the development, implementation and management of corporate and departmental policies and procedures and be able to ensure that employees comply with them.
Strong interpersonal skills and be able to build constructive relationships both internally and with sponsor personnel.
Be able to consistently meet deadlines and complete tasks according to established levels of quality.
Approximately 30% travel.

To apply:email resumes with salary requirements to hr@encorium.com

E/O/E

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Encorium is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Encorium via-email, the Internet or directly to hiring managers at Encorium in any form without a valid written search agreement in place for that position will be deemed the sole property of Encorium, and no fee will be paid in the event the candidate is hired by Encorium as a result of the referral or through other means.

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