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
Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compounds 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 compounds efficacy safety and positive impact on patients lives.
Accountable for all study investigational medical product (IMP) including oversight of the receiptdispensing and return of used/unused IMP ensuring correct storage complying with company SOPs andCOPs and identifying opportunities for process improvement. Consistently serves as a source of clinicalexpertise to investigators clinic and support staff client services sponsors and others as needed. Incoordination with departmental management team coordinates interdepartmental communicationssupports departmental training and adherence to regulatory educational requirements as well assupports departmental QA/QC functions.
Dispenses IMP on all studies according to local regulations sponsor writteninstructions and SOPs.
Provides training to patients on self-administrating of IMP.
Oversees all study IMP and maintains accountability logs per study/sponsorrequirements.
Serves as pharmacy lead on incoming clinical study protocols; plans andprepares for accurate dosing including packaging preparation andadministration of doses.
Ensures adequate supplies of clinical samples are retained with documentation ofrandom selection procedure as required for study.
Serves as liaison and consultant to sponsors concerning pharmacy details forfuture and current protocols.
Interacts as a vital member of the site team offering guidance on pharmacyprocedures and operations specific to each protocol.
Serves as departmental resource for pharmacy-related clinical inquiries frominvestigators clinic and support staff client services sponsor companies andothers 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 inthe dispensary. Manages temperature excursions and reports thereof as persponsors 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.
Bachelors degree in Pharmacy or Pharm D degree
Must hold a valid pharmacy licence within the country operating. Must be registered with local health careauthority.
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to8 years).
Trained in use of clean room essential
Experience with research beneficial
Expert 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 marketingauthorization submissions and international guidelines for conduct of clinical studies
Demonstrated ability to work independently analyze and work with attention to detail processingand 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
Required Experience:
Senior IC
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