Clinical Research Coordinator II

Job Description

Job Description

Position: Clinical Research Coordinator II

Purpose:

The purpose of the Clinical Research Coordinator II role is to ensure the successful execution of multiple concurrent clinical trials through effective study coordination, subject management, and cross-functional communication. This position serves as a primary liaison between investigators, study teams, sponsors, and clinical staff to maintain protocol compliance, uphold regulatory and documentation standards, and support the integrity and quality of clinical research activities. By applying advanced knowledge of study protocols, strong organizational skills, and sound judgment, the Clinical Research Coordinator II contributes to the timely, efficient, and high-quality conduct of clinical studies that advance research objectives and improve patient outcomes.

Position Summary:

The Clinical Research Coordinator II is responsible for the coordination and administration of overlapping clinical studies. Serves as the main point of contact for sponsors for assigned trials. The Study Coordinator will perform diverse administrative duties requiring analysis. The position requires sound judgment and a high-level knowledge of study specific protocols. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. This position reports to the Site Manager or Site Director.

Key Responsibilities (Essential Functions):

• Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
• Manage multiple concurrent trials
• Assist with mentoring and training study team members
• 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 (if applicable) 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 ethics 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
• Collect, process and ship laboratory specimens
• Adherent to safety and privacy regulations

Education and Experience:

• BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Minimum 3 years of experience coordinating clinical trials, including the activities listed above
• Previous nursing, medical assistant experience in a clinical setting a plus
• CCRC certification a plus
• Demonstrated relationship building, with strong verbal and written skills.
• Ability to successfully coordinate protocols with overlapping timelines
• Ability to explain importance of GCP guidelines and their application
• Ability to train others on coordinating responsibilities and protocol adherence
• Able to follow clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
• Strong interpersonal skills with attention to detail a must
• Proven ethical and professional codes of conduct
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.

Skills and Competencies:

• Excellent communication, interpersonal, analytical and problem-solving skills
• Microsoft Office Suite proficiency
• Bilingual Required (location specific): Proficiency in Spanish and English, including the ability to speak, read, and write in both languages
• Writing and verbal communication skills
• Strong study documentation skills in compliance with ALCOA+ preferred
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. preferred
• Ability to work effectively with a team
• Ability to prioritize and manage multiple projects simultaneously
• 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
• Ability to travel for site network support, audits and or attend investigator meetings, as required.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.