SUMMARY: The Pharmacy Quality Coordinator, under the guidance of the Pharmacy Manager, is responsible for monitoring the quality and integrity of pharmacy documentation and procedures (i.e. dosing, dispensing, compounding, manufacturing). The Pharmacy Quality Coordinator works under the general supervision and guidance of the Pharmacy Manager.

RESPONSIBILITIES:
Tasks may include but are not limited to:

• Always represents Worldwide Clinical Trials Early Phase Services in a professional manner (verbal, written, and in appearance) when interacting with Sponsors, volunteers, outside vendors, and fellow employees.
• Review the study protocol for each study.
• Conducts Quality Control audits on 100% of pharmacy data during study conduction to ensure quality work is being performed by Worldwide staff.
• Assures quality and completeness of Dose Labels, Drug Accountability Tables, Retention Log Forms, Dispensation Forms, Pharmacy Compounding Manuals, Manufacturing Batch Record, and other pharmacy documentation.
• Present in pharmacy for drug dispensation, compounding, and manufacturing, as needed, to ensure Work Instructions, standard operating procedures, and regulatory guidelines are adhered to.
• Able to navigate and operate Trackwise daily.
• Responsible for requesting, scheduling, and attending any training required for this position.
• Responsible for completing all necessary training for the position, including Work Instructions and SOPs.
• Performs additional assignments as warranted by upcoming and ongoing clinical research studies.

OTHER SKILLS AND ABILITIES:

• Excellent written and oral communication skills.
• Ability to understand complex written and oral instructions.
• Basic computer knowledge and applications are required for the generation of business correspondence and the preparation of regulatory and other study documents.
• Strong interpersonal skills.
• Excellent attention to detail.
• Exceptional organizational skills.
• Ability to set and meet deadlines with high-quality work.
• Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting
• Possible equipment includes, but is not limited to microscope, computers, rolling carts, fax machines, photocopiers, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, and allergy testing equipment, scales, calculators, vital signs equipment, ECG equipment, and other medical equipment.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

REQUIREMENTS:
Required: Bachelor’s degree, with at least 1-year quality control experience or 8 months of equivalent training.

Preferred: Bachelor’s degree (preferably in the field of Health); at least 1 year of experience with Regulatory documents and/or Quality Control/Quality Assurance.

Other: Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, and client contact, close attention to detail, multiple tasks, frequent interruptions, and fluctuation in workload.

Possible physical demands include, but are not limited to: Extended periods of time at a computer; lifting and carrying of objects weighing 5-50 pounds; hearing; seeing; gross and fine motor use of upper extremities; kneeling; walking; standing; leaning over for extended periods; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.

The Pharmacy Quality Coordinator is responsible for planning and managing his/her daily workload with the ultimate goal of meeting set study timelines. He/she must be self-motivated and able to manage multiple tasks and deadlines, to ensure that all deadlines are met. Must be able to coordinate with other clinical staff to communicate priorities and maintain an efficient workflow. Must be able to follow written and verbal communication and be punctual.