Valley Perinatal Services
Clinical Research Coordinator
Valley Perinatal Services, Phoenix, Arizona, United States, 85003
Job Overview
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director of Research and clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC manages the daily operations of clinical trials, ensuring studies follow approved protocols and Good Clinical Practice (GCP) guidelines. The CRC works collaboratively with the entire Valley Perinatal & Advanced Women's Care team, sponsors and CRO's to ensure productivity and timely completion of studies. Responsibilities include: Utilizing Good Clinical Practice, the CRC ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP): Screens, recruits, and enrolls study participants, conducts follow-up visits, and monitors participant safety and compliance throughout the trial
Collect and manages accurate study data, including case report forms, medical records, and reports on adverse events on paper and electronic sources as necessary
Specimen collection. Phlebotomy, MA or RN certification a plus
Ensure participant safety
Compensate participants directly or via third party as directed
Maintains study documentation, ensures ethical practices, and prepares for audits by regulatory bodies like the FDA
Coordinate with the research team and regulatory bodies (as needed)
Act as a key liaison between the study's PI, research participants, and external stakeholders.
Plans, directs, and coordinates day-to-day study activities to ensure adherence to protocols and regulatory requirements.
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Participate w/ PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
Supports on-site and remote monitoring activities including visit coordination and query resolution.
Acts as a primary contact for participants and serves as a liaison between the PI, site staff, laboratories, and other healthcare professionals
Performs assigned study activities and attends study meetings on a regular basis.
Qualifications: · Candidates with a bachelor's degree in a scientific, health related, or business administration program, preferred. · Candidates must have at least one year of experience in a clinical research environment. Will consider OB clinical experience in lieu of research · Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts · Detail-oriented and meticulous in all aspects of work · Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative · Must have professional demeanor and strong communication skills with the public as well as physicians/researchers · Ability to work well independently as well as in team environment · Strong interpersonal, customer service, and multi-tasking skills are critical · Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research and clinical environment. Experience in using Athena, Medrio and Castor is a plus. · Ability to be flexible, organized, detail-oriented and tenacious in follow-through · Possess the ability to work well under pressure, multi-task and manage deadlines · Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures · Bilingual in Spanish is preferred but not required. Job Type: Full-time Pay: $50, $60,000.00 per year Experience: Clinical research: 1 year (Required) Work Location: In person
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director of Research and clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC manages the daily operations of clinical trials, ensuring studies follow approved protocols and Good Clinical Practice (GCP) guidelines. The CRC works collaboratively with the entire Valley Perinatal & Advanced Women's Care team, sponsors and CRO's to ensure productivity and timely completion of studies. Responsibilities include: Utilizing Good Clinical Practice, the CRC ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP): Screens, recruits, and enrolls study participants, conducts follow-up visits, and monitors participant safety and compliance throughout the trial
Collect and manages accurate study data, including case report forms, medical records, and reports on adverse events on paper and electronic sources as necessary
Specimen collection. Phlebotomy, MA or RN certification a plus
Ensure participant safety
Compensate participants directly or via third party as directed
Maintains study documentation, ensures ethical practices, and prepares for audits by regulatory bodies like the FDA
Coordinate with the research team and regulatory bodies (as needed)
Act as a key liaison between the study's PI, research participants, and external stakeholders.
Plans, directs, and coordinates day-to-day study activities to ensure adherence to protocols and regulatory requirements.
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Participate w/ PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
Supports on-site and remote monitoring activities including visit coordination and query resolution.
Acts as a primary contact for participants and serves as a liaison between the PI, site staff, laboratories, and other healthcare professionals
Performs assigned study activities and attends study meetings on a regular basis.
Qualifications: · Candidates with a bachelor's degree in a scientific, health related, or business administration program, preferred. · Candidates must have at least one year of experience in a clinical research environment. Will consider OB clinical experience in lieu of research · Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts · Detail-oriented and meticulous in all aspects of work · Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative · Must have professional demeanor and strong communication skills with the public as well as physicians/researchers · Ability to work well independently as well as in team environment · Strong interpersonal, customer service, and multi-tasking skills are critical · Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research and clinical environment. Experience in using Athena, Medrio and Castor is a plus. · Ability to be flexible, organized, detail-oriented and tenacious in follow-through · Possess the ability to work well under pressure, multi-task and manage deadlines · Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures · Bilingual in Spanish is preferred but not required. Job Type: Full-time Pay: $50, $60,000.00 per year Experience: Clinical research: 1 year (Required) Work Location: In person