Unblinded Coordinator/Pharmacy Tech

• Excellence and Consistency
• Collaborative Innovation
• Respect for our Subjects, Sponsors and Team Members
• Community
• Unimpeachable Ethics

Primary Responsibilities:

• Ensure maintenance of accurate and complete documentation, including but not limited to IP accountability logs, temperature excursion forms, and study related communications.
• Organizational management of all aspects of investigational product dispensing and administering.
• Utilizes requisite equipment, non-sterile and/or compounding supplies and computer systems as appropriate for the procurement, preparation for verification and/or delivery of medication.
• Area clean up after IP Mixing/production.
• Possess a sound and in-depth understanding of each investigational product and each study protocol.
• Basic understanding of SOPs and ensure they are adhered to in the conduct of the clinical research study.
• Ensure communication of all IP related issues/problems to the PI and Site/General Manager or Team Lead (if applicable)

• Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
• Review with the President/Principal Investigator the IP requirements of each protocol, ensuring necessary storage is available.
• Receive IP and verify receipt as directed, including temperature stability.
• Ensure IP is stored according to protocol specifications.
• Ensure temperature is monitored and that temperature excursions are reported as needed.
• Ensure there is sufficient supply of IP and order more as needed.
• Inventory IP for expiration dates.
• Follow applicable requirements for controlled substances.
• If applicable, use the IVRS/IWRS for IP related tasks as required.
• Ensure the randomization procedure is followed as per protocol guidelines.
• Ensure blinding codes, if applicable, have been received from the sponsor/CRO and are stored in a secure location.
• Maintain accountability and dispensing logs.
• Complete all required documentation in a legible and timely fashion.
• If needed, administer study drug therapy (as legally appropriate).
• Attend study-related meetings as appropriate.
• Works with monitors on IP reconciliation
• Effectively communicate with clinical research sponsors, CROs, monitors/CRAs, IRBS, laboratories and clinical personnel within the research industry. Work with monitors on IP reconciliation.
• Return or destroy IP as required by the sponsor/CRO.
• Maintain crash cart inventory, if applicable
• Other duties as assigned

Additional Responsibilities (Check If Applicable):

Cross train in Clinical Research Coordinator (blinded) duties to serve as backup.

Desired Skills and Qualifications:

• Successful completion of a formal medical/clinical educational program preferred. Strong knowledge of medical terminology and the ability to learn quickly.
• Clinical experience involving patient care in a healthcare environment preferred but not required.
• Ability to interpret and perform clinical, laboratory and diagnostic tests (such as vital signs, height, weight, temperature, etc.) preferred.
• Willingness to work in a fast-paced environment where processes change and improve continually.
• Able to function independently without constant supervision and adapt to change.
• Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach.
• Professional and highly motivated “self-starter” with the ability to exercise initiative.
• Excellent task management and prioritization skills.
• Proven ability to successfully build and cultivate excellent long-term relationships
• Excellent follow up

Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.