Job Title:
Clinical Quality Specialist II

Req #:
4612BR

Job Description:
Support the Global Clinical Programs Clinical Quality and Document Control function with a primary responsibility for procedure development and department training.

Job Duties:
Generate and/or revise department SOPs, using end-user feedback, best practices, applicable regulations and guidance documents; maintain SOP development schedule and track progress; conduct and maintain program to ensure staff training of department SOPs and processes, functional tasks, and Good Clinical Practices regulations and guidelines; conduct GCP training for clinical investigators and staff as necessary. Support department audit needs including quality control or assurance activities for SOP compliance and other clinical elements. Participate in the evaluation of procedures and tools for clinical study processes and identify opportunities for improvement; develop or revise procedures or tools to improve performance and compliance. Assist in the review of clinical study and regulatory documents (i.e., protocols, ICFs, advertisement, approvals, etc.) for compliance to department SOPs and applicable Good Clinical Practices (FDA, ICH, ISO, etc.); provide direction and advise as requested for clinical trial compliance issues. Support department management when hosting FDA inspections.

Qualifications


Education:
Bachelor's degree preferably in biological or medical sciences. Experience: 5 years experience in a compliance, regulatory, or clinical environment, preferably with at least 2 years Good Clinical Practices training experience.

Special Skills:
Expert organizational, written, and verbal communication skills and the ability to present in a professional manner to adult learners required for this role. Ability to successfully facilitate meetings to drive consensus is also expected in this role. Specialized Training: Extensive knowledge of GCP regulations/guidelines and HIPAA Privacy Rule as they pertain to clinical research, and a good understanding of drug and device clinical trial development processes and clinical monitoring practices.

Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes

Status Full-Time