Clinical Study Coordinator-JCCT

Description:

Position: Study Coordinator

Location: JCCT Lenexa, KS

Department: Study Management

Purpose:

The Study Coordinator is responsible for the coordination and administration of clinical studies under the direction of the Director of Study Management, and the Medical Director/Principal Investigator.

Position Summary:

This position will develop, implement and coordinate research and administrative procedures for the successful management of clinical studies. The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. This position will report directly to the Clinical Study Team Manager.

Key Responsibilities (Essential Functions):

• Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
• Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
• Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
• Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
• Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
• Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
• Communicate with Nursing staff on an ongoing basis regarding study updates, amendments/ changes.
• Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
• Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
• Professional communication and collaborative work ethic with CRAs at Site visits.
• Order and track supplies or devices necessary for study completion.
• Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
• Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
• Track enrollment status of volunteers and documentation in Clinical Conductor system.
• Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
• Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
• Adherent to safety and privacy regulations
• Other duties as assigned

Education and Work Experience:

• High school diploma or GED is required; Bachelor’s degree in Science is preferred
• 3 to 5 years of experience in a clinical research setting or related work environment is preferred
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
• Familiarity with or ability to learn clinical trial management system software

Skills and Competencies:

• Excellent communication, interpersonal, analytical and problem-solving skills Microsoft Office Suite proficiency
• Writing and verbal communication skills
• Strong study documentation skills in compliance with ALCOA+
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc.
• Ability to work effectively with a team
• Ability to manage small projects personally and work independently
• Ability to prioritize and manage multiple projects simultaneously
• Memory to retain information and know where to research answers
• Time management skills
• Organizational skills
• Detail oriented with the ability to perform at a high level of accuracy
• Demonstrates strong critical thinking, problem solving skills
• Self-motivated
• Must be results oriented, multi-tasking, quick learner
• Respond to the urgent needs of the team and show a strong track record of meeting deadline

Physical Requirements:

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
• Ability to lift and/or move up to 20 pounds

Why JCCT?

JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.

We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.

Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.

If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!

EEO

JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Requirements: