Clinical Research Coordinator

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Clinical Research Coordinator is a primary point of contact for study participants, the Primary Investigator (PI), the Clinical Study Manager (CSM), and Department Managers in all study conduct and/or participant-related matters on the clinical research unit floor.  

How you’ll spend your day

• Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP’s), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable
• Supervises and coordinates assigned studies while working closely with CSMs and other departments to ensure all studies are conducted according to protocol 
• Oversees and monitors the well-being and safety of study participants by active assessment as well as by always serving as a visible point of contact  
• Facilitates verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensures appropriate follow-through
• Assists the PI with the review of laboratory data results for both the selection and randomization of study participants and for the monitoring of safety parameters while study conduct is ongoing
• Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs), ensures proper documentation and reporting of all AEs, including follow up of open AEs when subjects are not in-house, and provides any appropriate clinical care or instructions to subjects, as directed by the PI or as deemed medically necessary by their professional judgment
• Continuously communicates the progress of study conduct to PI, CSM, and members of the clinical study team through various methods of communication
• Immediately notifies the PI, CSM, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event (SAE) by a study participant and initiates documentation of the event
• Enforces rules and regulations with study participants and handles participant complaints efficiently and effectively, maintaining participant satisfaction
• Maintains compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study 
• In the absence of the Clinical Study Manager, performs as floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor
• Demonstrates professionalism and provides leadership to the various members of the clinical study team
• Administers study medication according to study protocol, demonstrates thorough understanding of study medications, and administers concomitant medication as directed by the PI and maintains accurate and timely documentation of the process
• Coordinates with the scheduling department to ensure coverage of clinical conduct activities
• Works with CSM and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction and feedback as needed
• Oversees the completion of all End of Study or Early Termination activities by study participants, inclusive of follow-up for the close-out of any outstanding items (i.e. AEs, physical exams, lab repeats, etc.) after subjects have been discharged from the clinic 
• Provides administrative and operational support to ensure successful conduct of study protocols

Your experience and qualifications

Education: 

• A nursing degree and in-state licensure is required. 
   

Experience:

• Minimum of two (2) years of experience in a clinical research environment
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific experience listed above.
• Certification/Licensure Advanced Cardiovascular Life Support (ACLS) certification and Nurse Licensure in the State of Florida are required.
• Knowledge, Skills, Abilitie