Clinical Research Coordinator: Study Setup & Compliance

Phoenix Children's Hospital, Inc.; Phoenix (AZ); On-site; USD 55,000 - 75,000; Full time

Job summary

Phoenix Children's Hospital, Inc. in Phoenix, AZ, is seeking a Research Coordinator to manage a variety of oncology studies from start to finish, including specimen procurement, data entry, regulatory filing, and study documentation.

The role requires coordinating IRB submissions, ensuring compliance with FDA/GCP, assisting in participant recruitment, and supporting study budgets and feasibility assessments with the PI and team.

Qualifications

• Bachelor’s degree in related field or equivalent combination of education and experience. Required
• One year of clinical research experience or equivalent clinical research training program approved by Director, Clinical Research Operations. Required
• Proven ability to successfully coordinate multiple studies adhering to regulatory and institutional guidelines. Required
• Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care. Required
• ACRP or SOCRA Clinical Research Certification. Preferred
• Clinical Research Training Certification. Preferred
• Phlebotomy Certification. Preferred

Responsibilities

• Ensure assigned studies are conducted in accordance with FDA, OHRP, GCP, and institutional guidelines.
• Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
• Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis.
• Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors.
• With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants.
• Completes all tasks required by study sponsors.
• Provides regulatory documents to sponsor in timely manner.
• Completes case report forms, data entry, and maintains source documentation for all study participants.
• Tracks and reports adverse events per sponsor and institutional guidelines.
• Coordinates research monitor visits and responds to all data queries.
• Coordinates the process for opening new studies.
• Obtains needed background material(s) on proposed research projects; presents findings and information to principal investigator.
• Completes feasibility questionnaires.
• Circulates the confidentiality disclosure and trial agreements to the appropriate parties.
• Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial.
• Assists in development of workflow procedures for study team based on specific protocol.
• Participates in recruitment and selection of study participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
• Coordinates and schedules a variety of medical procedures/tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol.
• In conjunction with the principal investigator, research pharmacist, and other members of the research study team, provides study specific education to the participant and their family.
• Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
• Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
• Performs miscellaneous job related duties as requested.

Skills

Coordination

Communication

Regulatory compliance

Education

Bachelor’s degree

Job description

Phoenix Children's Hospital, Inc. in Phoenix, AZ, is seeking a Research Coordinator to manage a variety of oncology studies from start to finish, including specimen procurement, data entry, regulatory filing, and study documentation.

The role requires coordinating IRB submissions, ensuring compliance with FDA/GCP, assisting in participant recruitment, and supporting study budgets and feasibility assessments with the PI and team.