Clinical Research Coordinator jobs in United States
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Phoenix Children's · 18 hours ago

Clinical Research Coordinator

Phoenix Children's is a leading pediatric health system focused on providing exceptional care and innovative research. The Clinical Research Coordinator will be responsible for coordinating various research projects, ensuring compliance with regulatory requirements, and supporting clinical departments in the recruitment and management of study participants.

Health CareHospital

Responsibilities

Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties:
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(s)
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. This may include study specific procedures, diary/study log documentation, proper dosage/administration, and disease treatment
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

Qualification

Clinical Research ExperienceRegulatory ComplianceStudy CoordinationACRP CertificationSOCRA CertificationClinical Research TrainingPhlebotomy CertificationInterdisciplinary Communication

Required

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

Preferred

ACRP or SOCRA Clinical Research Certification
Clinical Research Training Certification
Phlebotomy Certification

Company

Phoenix Children's

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Phoenix Children's is one of the nations fastest growing health systems providing high quality care to the complex patients.