The role involves coordinating and collaborating with the Pharmacist to support clinical investigational drug trials, ensuring accurate and efficient dispensing of medication and performing required cross-functional duties. Essential duties include reading and understanding study protocols, monitoring pharmacy activities daily for adherence, and preparing/dispensing investigational drugs according to IRB-approved protocols.
Requirements summary
Candidates must be able to communicate effectively verbally and in writing and must possess clinical research experience or be a currently licensed nurse without disciplinary action. The role requires good interpersonal skills, self-motivation, the ability to perform tasks independently, and capability in handling pharmacy tasks relevant to licensure or training.
Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials.
Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country.
Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.
Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.
We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
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
Coordinates and collaborates with the Pharmacist in providing support of clinical investigational drug trials; provide accurate and efficient dispensing of medication and perform cross functional duties as required. May act as a resource to other staff with pharmacy related questions.
Essential Responsibilities and Duties
Reads and understands all study protocol and pharmacy manual requirements regarding the management of study drug and pharmacy related tasks.
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.
Ensures access to all studies. This may include IWRS/IVRS, IRT, SBIR, this may vary by protocol.
Monitors pharmacy activities on a daily basis to ensure adherence to study protocols and dispensing procedures.
Prepares and dispenses investigational drugs in accordance with the IRB-approved protocols.
Attends training for new studies to ensure IP/Pharmacy management is thoroughly understood and executed.
Organizes all important communication regarding IP and file in each individual study IP binder.
Ensures all IP logs are accurate and up to date.
Benefits
Life Insurance
Dental
Vision
STD
LTD
Health Insurance
401k
Monitors visits by reviewing all confirmation letters to ensure the IP records are up-to-date and accurate;
reviewing all follow up letters to ensure all action items are addressed before next visit;
reviewing the site calendar to prepare for all monitor visits; and scheduling monitoring visits.
Assists with study in-services and other training as needed. This may also apply to off-site studies.
Ensures IP team has signed all study related logs.
Maintains detailed record of controlled medication and daily count at each shift change with re-order if needed.
Reviews source documents for accuracy and request changes, as needed.
Ensures the appropriate storage of investigational drugs according to the protocol and FDA guidelines.
Monitors temperature of pharmacy storage areas and report any temperature deviations of study drug to sponsor.
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.
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 currently licensed nurse without any disciplinary action.
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.
Must 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.
