Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Investigational Product Coordinator is responsible for preparing and dispensing study drug, providing drug-related information to subjects and staff in compliance with GCP, ICH, HIPAA, FDA, USP 797, USP 800, state Boards of Pharmacy, and company SOPs.
The Investigational Product Coordinator is responsible for preparing and dispensing study drug, providing drug-related information to subjects and staff in compliance with GCP, ICH, HIPAA, FDA, USP 797, USP 800, state Boards of Pharmacy, and company SOPs.
Essential Job Duties:
Under the direction of the Lead Research Pharmacist (or similar) and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with GCP, ICH, HIPPA, FDA, USP 797, USP 800, state Boards of Pharmacy and company SOPs:
- Integration of investigational medication use, pharmacy workflow, subject medication safety activities and regulatory standards;
- Coordinating, and advising site staff on drug distribution services for investigational medications;
- Identify and justify needs for additional resources, or redeploying resources in new ways to meet needs;
- Prepares, labels (if required) and dispenses investigational medications, and provides drug-related information and education for subjects and site staff;
- Dispenses controlled substances as part of a research study. Maintains appropriate inventory records, documentation of receipt and ensures proper storage conditions
- Ensures safety and care for all research subjects as it relates to investigational medication preparation and dispensing;
- Promotes individual professional growth and development by meeting requirements for mandatory/continuing education and skills competency; supports department-based goals which contribute to the success of the organization; serves as mentor and resource to less experienced staff
- Other duties as assigned.
Minimum Qualifications: An associate’s degree and 1+ years’ related experience, OR an equivalent combination of education and experience, is required. Certified Pharmacy Technician (CPhT) credential is required. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, web applications,
- Strong organizational skills and attention to detail.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, management, and external customers.
- Well-developed written and verbal communication skills.
- Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.