Investigational Products Coordinator

About Us:

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:

With moderate oversight, the Investigational Products Coordinator (IP Coord.) will assist the IP Manager in providing support of clinical investigational drug trials; provide accurate and efficient dispensing of medication and perform cross functional duties as required.

Essential Responsibilities and Duties:

• Monitors pharmacy activities daily to ensure adherence to study protocols and dispensing procedures.
• Prepares and dispenses investigational drugs in accordance with the IRB-approved protocols.
• Assists in preparing blinded and unblinded study products.
• Ensures the appropriate storage of investigational drugs according to the protocol and FDA guidelines.
• Monitors temperature of pharmacy storage areas and alerts IP Manager of any temperature excursions of study drug.
• Assists in ordering, receiving, unpacking and storing pharmaceuticals and supplies.
• Rotates stock to ensure use before expiration date.
• Monitors expiration date and supply of drug for clinical trials.
• Reviews unblinded source documents for accuracy and request changes, as needed.
• Assists in organization of all important communication regarding IP and file in each individual study IP binder.
• Ensures all IP logs are accurate and up to date.
• 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.
• Knowledge of basic medical practices and procedures.
• Knowledge of medications and medical supplies.
• Ability to maintain quality control standards.
• Ability to react calmly and effectively in emergency situations.
• Ability to interpret, adapt, and apply guidelines and procedures.
• Attention to detail.

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.