Auftragsdetails

Our client requires an Investigational Drug Control Unit Consultant for a 6-month, on-site engagement at their Bethesda, MD facility. Duties and responsibilities to include, but are not limited to:

• Meets with Principal Investigator to design the practical aspects of clinical trials before they begin such as randomization, stratification and investigational drug accountability plans, and the type and quantity of supplies needed. These transactions are often of such gravity that the protocol would be revised based on the findings and advice of the pharmacists at Investigational Drug Control Unit.
• Oversees the workflow of incoming protocols and assigns them to the pharmacists properly.
• Acts as the deputy to the service chief with full powers and responsibilities to direct resources where and when they are needed to ensure that patient trials go forward without error or delay.
• Assists for the pharmacists to attend site initiation visits, site qualifying visits and protocol start-up meetings.
• Acts as liaison with and directs other department representatives by informing and instructing them on the myriad aspects of protocol initiation and implementation.
• Often instructs the investigator on statistical aspects of the clinical trial to minimize the chance of study failure as well as expense and risk to patients.
• Offers advice on drug accountability aspects that are critical for the investigator to comply with applicable federal laws.
• Interacts with physicians, nurses, outside sponsors, and other health professionals during the course of the clinical trial to make needed adjustments to procedures and specifications. In many cases the operations being conducted are unprecedented. Accordingly, it is not unusual to be faced with unforeseen problems which require swift, critical decisions.
• Serves as a source of experience for the investigators in matters that relate to financial, logistical, legal, and patient safety aspects of a process that is by nature full of uncertainties.
• Responsible for keeping up with current literature on a wide range of subjects relating to Pharmacy practice and with laws and regulations applicable to investigational new drugs.
• Leads the daily huddle to make sure issues are identified and handled in a timely manner.
• Supports the creation and implementation of Standard Operating Procedures (SOPs) and Policies and Procedures (P&Ps) related to protocol execution and departmental needs.
• Collaborates with physicians, Principal Investigators (PIs) and research staff in the development, review, implementation, management, closeout, and evaluation of research protocols.

• Qualified candidates will possess a Bachelor’s degree in related field along with 8 plus years related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Experience with temperature mapping.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• Must be willing to travel regionally and/or nationally throughout the US.

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***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***