Lead, Clinical Research Coordinator

Healthcare Outcomes Performance Co. (HOPCo); Phoenix (AZ); On-site; USD 65,000 - 85,000; Full time

Job summary

Healthcare Outcomes Performance Co. (HOPCo) seeks a Clinical Research Coordinator to oversee clinical research operations in Phoenix, AZ. You will coordinate protocols, ensure regulatory compliance, and manage data collection for studies involving human subjects.

Responsibilities include participant recruitment, informed consent, scheduling, and communication with sponsors. The ideal candidate has 4+ years in healthcare research and CCR certification is preferred, with travel as needed.

Qualifications

• Bachelor's degree with 3+ years in clinical trials.
• Associates with CCR accepted.
• Knowledge of ICH-GCP and regulatory guidelines.
• Experience with data collection and IRB submissions.

Responsibilities

• Assist protocol development and assess feasibility within clinical practice.
• Prepare regulatory submissions and maintain study documentation.
• Recruit participants via referrals or ads.
• Schedule visits, screen eligibility, obtain informed consent.
• Manage data collection, entry, and analysis.
• Complete case report forms and maintain study records.
• Coordinate lab tests and imaging when required.
• Provide patient education on investigational treatments.
• Train staff on study protocols.
• Ensure SOPs and regulatory compliance.

Skills

Clinical trial coordination

Regulatory compliance

Communication skills

Education

Bachelor's degree + 3 years clinical trial experience OR Associate's degree + CCR

Job description

GENERAL STATEMENT OF DUTIES

Coordinates and oversees clinical or field operation of research projects involving human subjects. Leads in assessing, planning, implementing clinical research study protocols/designs. Is responsible for subject consenting, data collection, and regulatory compliance in clinical research studies.

GENERAL STATEMENT OF DUTIES

Coordinates and oversees clinical or field operation of research projects involving human subjects. Leads in assessing, planning, implementing clinical research study protocols/designs. Is responsible for subject consenting, data collection, and regulatory compliance in clinical research studies.

Essential Functions

• 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

EDUCATION

• Bachelor's degree AND three years of clinical trial experience OR Associates Degree AND Certified Clinical Research Coordinator

Experience

• Four plus years experience in the health care field or an equivalent combination of education and experience.
• Certified Clinical Research Coordinator Preferred

KNOWLEDGE

• 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

Skills

• 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

Abilities

• Ability to communicate clearly and effectively
• Ability to set priorities among multiple projects
• Ability to interact with providers, clinic and hospital staff

ENVIRONMENTAL WORKING CONDITIONS

• Normal office environment.
• Work in clinical and hospital environments.
• Some travel within the community.
• Limited travel outside of the community.

PHYSICAL/MENTAL DEMANDS

• Requires sitting and standing associated with a normal office environment.
• Some bending and stretching are required.
• Manual dexterity using a calculator and computer keyboard.

Organizational Requirements

• HOPCo Mission, Vision, and Values must be read and signed.

This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities, and working conditions may change as needs evolve.