Protocol Manager Jobs in Dallas, TX (NOW HIRING)

Location

Office-based in Irving, TX

Job Summary

The IDS Pharmacy Technician must be knowledgeable in standard pharmacy practices, including USP<797> and USP<800>, in addition to research and oncology care practices. The IDS Pharmacy Technician advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.

Essential Duties and Responsibilities

Essential and other important responsibilities and duties may include but are not limited to the following:

Protocol Compliance

• Enters concomitant medications into the electronic medical record (EMR).

• Prepares investigational product (IP) per pharmacy manual instructions and site compounding sheets.

Medication Dispensing and Preparation for Conventional and Investigational Products (IP)

• Reviews all chemotherapy labels and compounding instructions for accuracy of dose and dose calculations.

• Compounds all IV doses of investigational products and conventional agents, including supportive care medications, cellular therapies, and hazardous compounds.

• Have an excellent working knowledge of good clinical practice (GCP), good manufacturing practice (GMP) and all procedures, legislation or national guidelines relating to aseptic preparation (USP<797>) and dispensing of hazardous medication (USP<800>) and clinical trials.

• Ensure that IDS services are flexible and responsive to research staff and patients that the services meet patient requirements / needs.

Management of Investigational Product and Drug Accountability

• Maintains responsibility for the management of the inventory for protocols, including ordering, receiving, and returning IP, as required.

• Maintains responsibility for the management of other supplies necessary to perform IP preparation, including, but not limited to IV bags, IV tubing, cleaning products, personal protective equipment (PPE), etc.

• Maintains responsibility for ordering conventional agents weekly as needed.

• Ensure that correct procedures for receipt of IP and storage of IP are followed.

• Maintain appropriate and accurate records for all protocols, including drug accountability, drug receipt, temperature monitoring, expiration / retest dating and staff training, etc.

• Ensure that procedures for the return and disposal of IP are current and being followed.

• For oral IP: review patient medication diaries and IP returns for accuracy and completeness in conjunction with the treatment room nurses and research coordinators. Document this review and return it in Vestigo. Ensure medication diary is scanned and uploaded into eDOCS.

• Ensure that products used in clinical trials are managed according to standard operating procedures (SOPs), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and any other applicable regulations.

• Assist with monitoring visits and answering any monitor queries.

Administrative and Supervisory Responsibilities

• Contributes to the development, integration and monitoring of written procedures and workflows covering all aspects of the IDS.

• Performs monthly investigational product inventory and documents in Vestigo.

• Performs monthly conventional inventory, assists pharmacist in investigating inventory discrepancies / issues.

• Provides coverage for other IDS employees when they are out due to illness or scheduled PTO.

• Collects and documents workload measurement statistics, provides other data, as required.

• Assists the VP of Investigational Drug Services in preparation and review of documentation for audits.

Education Responsibilities

• Orients IDS staff, pharmacy residents and pharmacy students to the IDS pharmacy technician role with respect to protocols, as required.

• Maintain continuing education requirements to maintain Texas Pharmacy Technician license and protocol compliance training, i.e. GCP / PHRS.

Data and Document Management and Information Technology

• Assist in the scanning. review and uploading of protocol documentation into eDOCS.

• Upload resume, license(s), certification(s) and training documents into eDOCS.

• Vestigo will be utilized as our IP and protocol management software. All IDS staff will become knowledgeable in the use of this program.

Required Education and Experience

• Current Pharmacy Technician License (required) in the state where the NEXT Oncology position is located.

• Current IV Certification (required) with at least 1 year of mixing experience.

• Current Chemotherapy Certification (preferred) with at least 6 months of mixing experience.

Why Join Us?

At NEXT Oncology (an Avacare Business), you'll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.