Clinical Research Coordinator II (30129)

Job Description

JOB TITLE: Clinical Research Coordinator III

FSLA STATUS: Exempt

Position Summary

Experienced Research Coordinator who plays a key role in supporting the growth of an expanding research department. Responsible for mentoring and training less experienced staff, ensuring adherence to protocols and regulatory requirements. Provides advanced expertise in managing complex clinical trials and contributes to process improvements to optimize study efficiency. Works closely with Principal Investigators (PIs) and Sub-Investigators (Sub-Is) on various studies. Collaborates within a large, motivated private practice, ensuring the department’s success in delivering high-quality research.

Job Relationships

• Reports to the Director of Clinical Research, Vice President of Research, Regional Market President, and the physicians at the local market
• Collaborates with experienced patient navigators, IT, data management, and Urology America clinical research staff.
  
  

ROLE QUALIFICATIONS: (experience, education, and skills)

• Independently manages significant and all key aspects of complex clinical trials
• Exhibits advanced expertise in the execution and oversight of complex clinical trials, ensuring adherence to protocol, regulatory standards, and timely documentation.
• Accurately reports visit details and trial activities to ensure proper revenue tracking and timely invoicing.
• Develops effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
• Able to manage multiple studies with varying indications.
• Leads complex, multi-site trials, ensuring compliance with protocol and regulatory requirements.
• Mentors Clinical Research Coordinators I and II, Research Assistants, and Research Interns providing guidance during new hire training, trial initiations, and transitions.
• Oversees work performed by Research Assistants and Research Interns as needed.
• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have at least 4-6 years of experience with conducting complex therapeutic area clinical trials.
• Urology based clinical experience preferred. Willingness to perform urology required procedures to conduct urology research.
• Certification via ACRP or the equivalent preferred.
• Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
• Excellent time management and prioritization skills.
• Strong communication skills and ability to interact with all levels of management, staff, physicians, CROs, sponsors, and vendors.
  
  

Essential Job Responsiblities

• Support building the research department in scope, size, reputation, and professionalism.
• Leads the recruitment of studies with the central recruitment team and champions recruitment goals.
• Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Obtain and maintain consent of patients with the highest ethical standards.
• Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
• Communicate with and support patients end to end during trial participation and their families as necessary.
• Work with the EMR and data management systems to complete all data and source requirements for visits.
• Must have or gain knowledge of relevant software/programs, including a CTMS.
• Have a mastery level of working knowledge of trial design, statistical methods, etc.
• Triage, record, and report adverse events. Record and report any protocol deviations.
• Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
• Directly work with the Regional Manager and Research Director to assist overseeing all daily operations and implementation of policies and procedures in the department.
• Maintain HIPAA compliant communication and confidentiality, at all times.
• Participate in site visits, SIVs, monitoring, etc.
• Complete necessary study close-out steps and documentation.
• Conduct blood draws and laboratory procedures as required per study.
• Manage IP accountability and perform drug dosing and instillations per study requirements.
• Assist with other duties assigned.
  
  

Performance Requirements

Knowledge

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices.
• Understanding of medical terminology.
  
  

Skills

• Ability to use multi-line phone systems and basic computer systems.
• Interpersonal communication with internal staff and external customers.
• Skill in reading medical chart terminology.
• Time Management.
• Phlebotomy
  
  

Abilities

• Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
• Elicit appropriate information for patients to clinic staff.
• Ability to read and understand information and ideas presented in writing.
• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.
  
  

Physical Demands And Work Environment

The physical demands and work environment characteristics described here are the 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:

• Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
• Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.