Pharmacy Technician

Pinnacle Clinical Research•Dallas, TX

19d

About The Position

The Pharmacy Technician assists with the day-to-day operations of clinical trials and manages the preparation and dispensation of compounded sterile investigational products to support efficient clinical team operations. The role requires competency in USP <797>, proper aseptic technique, and a strong background in sterile IV compounding. The technician works closely with the Clinical team, attends meetings and events to promote studies, and documents and reports on pharmacy operations and status. The position requires understanding clinical research priorities and organizing workflows to complete activities in a timely manner. It involves handling confidential information and reports directly to the Site Director. The Pharmacy Technician collaborates with team members and external vendors and supports patient care. The role also includes administrative tasks such as maintaining reports, spreadsheets, study documents, and electronic regulatory documents, and coordinating sponsor meetings about pharmacy-related items with the Clinical Research Project Manager. Duties and activities may change or be assigned at any time.

Requirements

High school diploma or GED.
Sterile compounding certificate.
Licensed Pharmacy Technician in the State of Texas.
Two years of Pharmacy Technician experience.
Proficiency in all Microsoft Office applications.
Organizational skills and strong time management, including attention to detail and the ability to track multiple projects.
Strong written and oral communication skills.
Knowledge of basic medical terminology.
Integrity and personal and professional values consistent with PCR’s standards and mission.
Compliance with company policies, code of ethics, and guiding values.
Ability to communicate effectively with internal and external contacts at all levels.
Ability to work independently and multitask in a fast-paced team environment.
Strong interpersonal skills, including interacting with people from diverse backgrounds and handling confidential or sensitive information with discretion and judgment.
Positive, friendly, and professional demeanor, particularly when interacting with patients.
Ability to collaborate with a team and interpret and adhere to clinical research protocols.
Strong problem-solving and decision-making skills, particularly under pressure; proactive identification and resolution of issues.
Self-motivated, results-oriented approach and ability to work effectively in an entrepreneurial environment.
Ability to work upright and/or stationary for 6–10 hours per day, frequent mobility, occasional squatting, kneeling, or bending, and light to moderate lifting or carrying of 20–50 pounds.

Responsibilities

Prepare investigational products, including sterile IV compounding, in compliance with USP <797> standards.
Receive investigational product shipments onsite, account for their contents, complete required documentation, confirm receipt in sponsor-assigned portals or notify the sponsor, and record shipments on IP logs.
Upload monthly temperature logs within the first week of the month and assess, document, and report temperature excursions, including sponsor paperwork.
Manage investigational product dispensing and return accountability, including double verification.
Manage the Pharmacy Binder on CRIO eREG and host unblinded routine monitoring visits.
Reconcile applicable pharmacy logs daily and maintain pharmacy organization and current investigational product supply.
Coordinate routine temperature monitor calibrations and complete manual temperature recording as applicable.
Perform investigational product administration and label investigational products for internal tracking.
Order supplies from a local pharmacy or selected vendors as applicable and maintain pharmacy supply inventories.
Ensure appropriate temperature conditions for the pharmacy and equipment, including refrigerators and freezers.
Train support staff members.
Coordinate investigational product returns with the Sponsor or CRO.
Call in prescriptions on behalf of PCR for patients when applicable to site process.
Provide subjects with investigational product instructions and education.
Collaborate and cross-train with Lab and Clinic personnel when applicable at the site.
Maintain subject and document confidentiality and comply with sponsor requirements, applicable regulations, and institutional policies and procedures.
Travel to provide additional support to other sites as needed.
Create and maintain reports and spreadsheets as requested.
Assist with maintaining study documents and electronic regulatory documents.
Schedule and coordinate sponsor meetings concerning pharmacy-related items alongside the Clinical Research Project Manager.