Investigational Drug services Technician Specialist
Investigational Drug services Technician Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Overview:
Job Description Summary:
Job Description:
Essential Functions:
Interprets and applies clinical trial terminology and practices such as randomization schemes flow charts and blinding.
Streamlines inventory management including maintaining levels monthly checks and updating records as per protocol requirements.
Ensures accurate and timely placement receipt verification and registration of inventory orders.
Follows studyspecific protocols for investigational drug preparation and dispensing including compounding unique sterile intravenous admixtures.
Administers the tracking of subject drug returns assesses protocol compliance and follow up for any missing investigational products.
Upholds solid recordkeeping systems for protocols temperature monitoring patient data and drug inventory.
Conducts review and audit of pharmacy trial documents to ensure compliance guidelines.
Education Requirement:
- BS or BA from accredited college or university preferred.
Licensure Requirement:
Board of Pharmacy technician license (Registered or Certified) required.
Certifications:
- Certification by PTCB and ongoing continuing education to maintain certification required.
- CCRP certification and ongoing continuing education to maintain certification strongly encouraged.
Skills:
- Ability to obtain and maintain Good Clinical Practice and Human Subjects Protection certification.
- Ability to obtain and maintain certification for shipment of biohazardous substances
- Ability to organize manage workload and help set priorities for self and others.
- Works independently with minimal supervision.
- Adaptability to stressful or urgent situations with short deadlines.
- Extreme attention to detail and accountability.
- Computer competency with Microsoft Office Applications.
- Understanding of FDA regulations in regard to clinical trials.
- Excellent communication and writing skills.
- Strong interpersonal skills and understanding of group dynamics.
- Advanced knowledge of medical terminology with demonstrated skills in algebra.
Experience:
- Experience in sterile compounding of hazardous agents preferred.
- Leadership experience preferred.
Physical Requirements:
OCCASIONALLY: Bend/twist Lifting / Carrying: 1120 lbs Lifting / Carrying: 2140 lbs Pushing / Pulling: 025 lbs Pushing / Pulling: 2640 lbs Squat/kneel
FREQUENTLY: Decision Making Interpreting Data Lifting / Carrying: 010 lbs Problem solving Sitting Standing
CONTINUOUSLY: Audible speech Chemicals/Medications Color vision Computer skills Depth perception Flexing/extending of neck Hand use: grasping gripping turning Hearing acuity Peripheral vision Reaching above shoulder Repetitive hand/arm use Seeing Far/near Walking
Additional Physical Requirements performed but not listed above:
(not specified)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified nor is it intended to limit or modify the right of any supervisor to assign direct and control the work of employees under their supervision. EOE M/F/Disability/Vet
Required Experience:
IC
Employment Type
Full-Time
