Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob Description
We are looking for a Research pharmacist to join our newly opened site!
TrialMed is a premier global clinical site network, offering comprehensive services for clinical trials from early to late phases (Phase I to Phase IV). As a unified brand, TrialMed consolidates all clinical trial offerings under one global name, ensuring a seamless experience for stakeholders.
Access to over 250 sites worldwide and a patient database of 20 million individuals, ensuring robust and diverse trial enrollments.
A patient-centric approach with capabilities for home trial services, allowing patients to participate in clinical trials from their homes or communities.
Comprehensive service offerings, including early development CRO services, consulting services, and clinical pharmacology services.
Join TrialMed and be part of a dynamic team dedicated to advancing medical research and improving patient care through innovative clinical
Location/Division Specific InformationOur Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.
Discover Impactful Work:Accountable for all study investigational medical product (IMP), including oversight of the receipt, dispensing and return of used/unused IMP, ensuring correct storage, complying with company SOPs and COPs and identifying opportunities for process improvement. Consistently serves as a source of clinical expertise to investigators, clinic and support staff, client services, sponsors, and others as needed. In coordination with departmental management team, coordinates interdepartmental communications, supports departmental training and adherence to regulatory educational requirements, as well as supports departmental QA/QC functions.
A Day in the Life:Dispenses IMP on all studies according to local regulations, sponsor written instructions and SOPs.
Provides training to patients on self-administrating of IMP.
Oversees all study IMP and maintains accountability logs per study/sponsor requirements.
Serves as pharmacy lead on incoming clinical study protocols; plans and prepares for accurate dosing including packaging, preparation, and administration of doses.
Ensures adequate supplies of clinical samples are retained with documentation of random selection procedure, as required for study.
Serves as liaison and consultant to sponsors concerning pharmacy details for future and current protocols.
Interacts as a vital member of the site team offering guidance on pharmacy procedures and operations specific to each protocol.
Serves as departmental resource for pharmacy-related clinical inquiries from investigators, clinic and support staff, client services, sponsor companies, and others as needed.
Participates in cross-training activities with other departments.
Collaborates with management on improving department processes and
procedures.
Ensures adherence to corporate procurement procedures.
Ensures correct storage of IMP on each study and maintains temperature logs in the dispensary. Manages temperature excursions and reports thereof as per sponsor’s written instructions and internal SOPs.
Oversees the safekeeping of code break envelopes.
Returns used and unused IMP to the sponsor/depot as per written instructions.
Keys to Success:Education and ExperienceBachelor's degree in Pharmacy or Pharm D degree
Must hold a valid pharmacy licence within the country operating. Must be registered with local health care authority.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’).
Trained in use of clean room essential,
Experience with research beneficial
Knowledge, Skills, AbilitiesExpert knowledge of important regulatory considerations
Proven ability to assess the safety and tolerability of different classes of drugs
Expert knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
Demonstrated ability to work independently, analyze and work with attention to detail, processing and prioritizing sensitive and complex information and problem solving
Advanced analytical ability
Demonstrated ability to exercise discretion and sound judgement
Effective strong decision-making, negotiation and influencing skills
Excellent organizational skills and detail-orientated leadership approach
Proficiency in basic computer applications
Effective interpersonal skills to work in a team environment
Excellent communication skills with Czech and English