Pharmacy Supervisor/Clinical Research Coordin

Pharmacy Supervisor/ Clinical Research Coordinator

Reports to: Associate Director, Clinical Operations

Supervises: Pharmacy Technician

Qualifications: Requires a Bachelor's degree, preferably in a scientific discipline or equivalent experience.Experience: A minimum of 2 years of experience as a registered Pharmacy Technician; additional experience involving the preparation of investigational study medications for clinical studies and clinical research is highly desirable. Knowledge of FDA regulatory requirements is necessary. Good communication skills with the ability to interact with the Principal Investigator, and Sub-Investigators, at Frontage Clinical Services, Inc. and sponsor personnel. Demonstrate superior knowledge of the clinical research process and medicine/ pharmacology.

Specific Responsibilities:

· Develop and implement inventory and drug accountability procedures for investigational study medication both at the level of the research subject and overall study.

· Develop and implement procedures to assure the proper storage conditions for investigational study medication

· Develop and implement procedures to prepare and dispense investigational study medication.

· Develop and implement procedures for the appropriate disposal of investigational study medication at the completion of a study performed at Frontage Clinical Research Center.

· Develop and implement procedures to assure investigational study medication is securely stored in the pharmacy at Frontage Clinical Research Center.

· Maintain appropriate log-in access to individuals authorized to access the pharmacy at Frontage Clinical Research Center in conjunction with the Medical Director/Principal Investigator.

· Implement and oversee the design and packaging of clinical drug supplies for specific studies upon request by the sponsor or Medical Director/Principal Investigator.

· Provide input into the clinical supplies section of study protocols as requested by the sponsor or Medical Director/Principal Investigator.

· Review and adhere to sponsor requirements as they pertain to investigational study medications for a specific study protocol (i.e., integrate sponsor requirements into Frontage procedures; resolve any discrepancies in consultation with Associate Director, Clinical Operations, and sponsor if necessary) Assists with the preparation of protocols, informed consents, protocol amendments and other necessary documents for review by the sponsors and IRB.

· Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.

· Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines.

· Actively involved in the recruitment and in the screening activities of research subjects to evaluate their eligibility for a clinical research study.

· Creates and performs QA/QC procedures

· Actively participate in any sponsor or FDA audit.

· Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.

· Review and adhere to sponsor requirements pertaining to study medications for specific study protocol (i.e., integrate sponsor requirements into Frontage procedures; resolve any discrepancies in consultation with Principal Investigator; Director, CRC Operations and sponsor if necessary.)

· Develops a strategy for implementing study procedures in compliance with the study protocol.

· Reads, understands, and follows Standard Operation Procedures (SOP’s) in coordinating studies. Responsible for self-training and maintaining training records.

· Performs study procedures (e.g., start intravenous lines, venipunctures, obtain biological specimen samples, processes specimen, obtain ECG recordings, vital signs, safety assessments, etc.) as required by the study protocol.

· Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.

· Records study data in the source documents. Evaluates and review study data to ensure accuracy and completeness.

· Transcribes study data from source documents to sponsor designated case report forms or records data for remote data entry if applicable.

· Resolves data queries in conjunction with the sponsor.

· Assists Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.

· Interacts with sponsor and Frontage senior management on subject recruitment activities, and study progress updates, and assists Frontage senior management with developing and tracking study budgets.

· Assist in maintaining pharmacy inventory and records accordingly; working with and under the supervision of a licensed pharmacist.

· Follow implemented procedures to dispense and to ensure proper storage conditions are being maintained for investigational study medication.

· Follow implemented procedures for the appropriate disposal of investigational study medication at the completion of a study performed at Frontage Clinical Services Inc.

· Follow implemented procedures to assure investigational study medication is securely stored in the pharmacy at Frontage Clinical Services

· Works on complex problems where analysis of situations or data requires an evaluation of numerous variables.

· Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

· Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Research Center personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters).

· Shows desire and initiative to increase knowledge and skills in clinical research.

· Participates in internal/external clinical meetings.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.