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Quality Assurance Clinical Trials

Location:
Boston, MA
Posted:
April 22, 2024

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Resume:

IJANG YVETTE TAH

Clinical Pharmacist

Methuen, United States

857-***-**** ad4690@r.postjobfree.com

Experienced and dedicated, with ten years of experience in pharmaceutical operations and quality management control. Excellent interpersonal communication skills and a strong background in clinical pharmacology and medication management. Extensive knowledge of pharmacy operations, FDA regulatory affairs, clinical trials of GCP, GMP & GLP, and quality assurance. Proven track record of proper customer advisement and an empathetic attitude towards customers. Superior training and coaching skills in drug information and administration.

•Oversee the day-to-day operation of clinical trials activities from study start to end (including data collection, entry, & analysis, IRB document preparation & submission, SOPs use/trainings)

•Ensure compliance with all state and federal laws and regulations.

•Responsible for CRA performance, project timelines, budget management, and documentation.

•Coordinate team efforts to improve the quality of trials and CRO oversight

•Work collaboratively with different stakeholders to manage & meet project objectives.

•Coordinate team meetings, develop annual training guidelines and manage clinical quality review analysis, determination, and disposition.

•Manage the Study’s Trial Master Files, & audit readiness

•Monitoring procedures and data according to GCP and ICH, local regulations, and protocol requirements

•Negotiate contracts between PIs and sponsors

Cambridge, MA

•Collaborated with pharmacists on duty to promote an error-free and productive Pharmacy department.

•Reviewed prescriptions and practiced safe quality assurance control for patients.

•Maintained computer records of dispensed medications.

•Provided guidance and assistance in the development and maintenance of the Drug Formulary.

•Effectively counseled patients on medication use.

•Worked closely with clinical teams, site directors, and operations staff to ensure continuous process improvement.

Byfield MA

•Accountable for implementation, management, supervision, and evaluation of all program activities following organizational, state, and federal standards.

•Employed qualifications and audits to ensure supplier quality was guaranteed.

•Managed staffing in terms of scheduling, training, and other program-related issues

•Supervised site managers on administrative, medical, and clinical functions.

•Represented Vinfen on a variety of committees (Pharmacy & Therapeutics, Department Meetings, Quality Management Committee, Department Leadership, Patient Care Leadership, market Pharmacy Directors)

Boston, MA

Doctor of Pharmacy Portland, Maine

BSc. in Pharmaceutical Science Boston, MA



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