Lead, Clinical Research Coordinator
Healthcare Outcomes Performance Company•Phoenix, AZ
•Hybrid
About The Position
Coordinates and oversees the clinical or field operation of research projects involving human subjects. Leads in assessing, planning, and implementing clinical research study protocols/designs. Is responsible for subject consenting, data collection, and regulatory compliance in clinical research studies.
Requirements
- Bachelor's degree AND three years of clinical trial experience OR Associates Degree AND Certified Clinical Research Coordinator
- Four plus years experience in the health care field or an equivalent combination of education and experience.
- Knowledge of the principles, practices, and techniques of clinical care
- Knowledge of clinic policies and procedures
- Knowledge of computer systems and applications
- Knowledge of medical practices, terminology
- Knowledge of organizational policies and procedures
- Knowledge of clinical research regulatory guidelines and regulations
- Skill in planning and organizing clinical trials
- Skill in evaluating the effectiveness of existing methods and procedures
- Skill in communicating with internal and external customers
- Ability to communicate clearly and effectively
- Ability to set priorities among multiple projects
- Ability to interact with providers, clinic and hospital staff
Nice To Haves
- Certified Clinical Research Coordinator Preferred
Responsibilities
- Assists with protocol development and/or reviews potential protocols to evaluate their feasibility and implementation within standard clinical practices
- Generates forms and prepares applications for regulatory approvals (e.g. Institutional Review Board), manages regulatory processes and documentation for assigned studies
- Recruits study participants by referrals or by placing advertisements on television, radio, or in newspapers
- Schedules study appointments; screens and evaluates potential participants to ensure they meet eligibility requirements; obtains informed consent to participate in studies.
- Manages, monitors and participates in research activities including data collection, data entry, and analysis for a research project.
- Completes case report forms for study participants and documents applicable data in study records/databases.
- Schedules and/or coordinates the scheduling of required laboratory tests, imaging studies, and/or exams
- Evaluates and/or develops patient educational materials and provides patient and/or family members with instructions on investigational drug/device administration and other pertinent information related to study participation.
- Trains, coordinates, and educates patient care team in the conduct of study protocols
- Inventories and requisitions research study supplies and equipment; arranges for repair and maintenance of equipment
- Coordinates and participates in monitoring visits with sponsors and regulatory agencies
- Ensures clinical research is conducted in compliance with all applicable SOPs, laws, and standards
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
