Investigational Product Manager - Pharmacy Technician

About Us:

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

Responsible for the management of all Investigational Products and Pharmacy related tasks. 

Compensation: $65k-$72k/year depending on education, experince, and skillset. 

Essential Responsibilities and Duties:

• Reads and understands all study protocol and pharmacy manual requirements regarding the management of study drug and pharmacy related tasks.
• Monitors pharmacy activities on a daily basis to ensure adherence to study protocols and dispensing procedures.
• Verifies documented training of the team.
• Ensures access to all studies. This may include IWRS/IVRS, IRT, SBIR, and may vary by protocol.
• Prepares and dispenses investigational drugs in accordance with the IRB-approved protocols.
• Attends all training for new studies to ensure IP/Pharmacy management is thoroughly understood and executed.
• Creates a Pharmacy/IP binder for all studies (where applicable), unless provided by sponsor.
• Reviews protocols and investigator’s brochures or other additional information supplied by the Principal Investigator and the study sponsor for clinical investigational drug trials as required.
• Organizes all important communication regarding IP and file in each individual study IP binder.
• Ensures all IP logs are accurate and up to date.
• Oversees the temperature monitoring system for all storage units on-site which may include on call availability for any temperature excursions that occur within the building.
• Conducts monthly review of all IP in each storage unit and maintains the spreadsheet listing the contents of each IP storage unit.
• Monitors visits: o Reviews all confirmation letters to ensure the IP records are up-to-date and accurate. o Reviews all follow-up letters to ensure all action items are addressed before next visit. o Reviews the site calendar to prepare for all monitor visits. o Schedules monitor visits.
• Copies the IP team on all study related correspondence with the sponsor.
• Provides training and professional expertise on the correct use and storage of study drug for study staff.
• Assists with study in-services and other training as needed. This may also apply to off-site studies.
• Oversees the proper IP close-out for each study.
• Ensures all witnesses of IP administration are well-trained and training is documented.
• Performs spot quality assurance checks, as requested by the Quality Assurance Manager, identifying problem areas and training needs.
• Keeps detailed record of controlled medication and daily count at each shift change with re-order if needed.
• Handles and maintains Investigational Product (IP) management system for receipt, accountability, storage and disposal.
• Monitors temperature of pharmacy storage areas and report any temperature deviations of study drug to sponsor.
• Prepares blinded study products and be responsible for emergency un-blinding, if required.
• Reviews source documents for accuracy and request changes, as needed.
• Communicates with the study team any discrepancies/violations noted during pharmacy procedures.
• Attends sponsor Investigator’s meetings, site initiations, web/teleconferences and staff meetings as needed.
• Updates study start up checklists to reflect tasks completed.
• Develops standard operating procedures for the pharmacy department to comply with company and regulatory requirements.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• Must be able to effectively communicate verbally and in writing.
• Clinical Research experience or nurse with a current license, without disciplinary action.
• Ability to independently coordinate and manage all aspects of IP/Pharmacy.
• Good Interpersonal skills, demonstrated through interactions with sponsor representatives, staff and subjects.
• Reflect the professional image of the company, upholding the company’s vision in actions, demeanor, and appearance.
• Be self-motivated and able to perform tasks independently.
• Capable of performing IP and Pharmacy tasks relevant to licensure and/or training.

Working Conditions

1. Indoor, Clinic environment.
2. Essential physical requirements include sitting, typing, standing, walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. On site work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.