Clinical Research Coordinator II or III (CRC 2-3) AMP

arizonaliverhealth; Chandler (AZ); Vor Ort; USD 38.000 - 50.000; Vollzeit

Zusammenfassung

Arizona Liver Health in Chandler, AZ is seeking a Clinical Research Coordinator II or III to support multicenter trials. The role includes coordinating protocols, data collection, patient assessments, and eligibility screening under the supervision of the Principal Investigator, in compliance with FDA CFR, GCP, and company SOPs.

This full-time, non-exempt position offers hourly pay of $27.50–$36.00, commensurate with experience, with opportunities to advance within ALH's clinical research

Qualifikationen

• Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.

Aufgaben

• Coordinate and implement assigned protocols in compliance with FDA CFR, GCP and SOPs.
• Collect and record clinical research data, assist in patient assessments, scheduling, maintain study files and study medication accountability.
• Recruit and screen potential participants, meet recruitment goals and maintain source documentation.
• Ensure compliance with regulatory, accreditation requirements, and SOPs; provide patient education and support.

Jobbeschreibung

About Us:

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

Job Summary:

Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II or III position in Chandler.

Title: Clinical Research Coordinator II or III (CRC 2-3) AMP

Compensation: $27.50 - $36.00 per hour, depending on experience and qualifications

Status: Full-time, Non-exempt

Essential job functions/duties:

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.
• Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs.
• Collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
• Develop management systems and prepare for study initiation
• Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol
• Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity about these protocols to staff and patients.
• Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
• Responsible for meeting recruitment goals for each study.
• May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
• Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
• Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
• Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
• Serves as a liaison to all physicians, employees, and third-party vendors.

Record data and study documentation:

• Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate.
• Assign patient stipend pay card at screening
• Document reason for screen-fail in real time
• Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
• Record data as directed using the appropriate media or platform
• Follow procedures for access and security for electronic data entry
• Review keyed data for accuracy as needed
• Send data to the data collection center on a timely basis
• Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
• Develop and/or edit source as needed independently or with Quality Assurance / Quality Control team to ensure compliance with protocol and EDC.
• Correct and edit data as directed and as appropriate.

Informed Consent

• Obtaining patient medical history and medication lists
• Phlebotomy and basic laboratory tests
• Processing & shipping labs for central and local labs
• Patient education and training
• ECG
• Administer questionnaires and assessments
• Vital signs
• Collect information for adverse event reporting
• Assist with efficacy assessments

Data Entry and Query Resolution

• Study drug administration, including injections
• Tracking study supply inventory and reordering when necessary
• Schedule patient visits in appropriate electronic systems
• Documenting all patient visits and communications in progress notes
• Document and record all AEs and SAEs as outlined in protocol
• Monitor and report adverse events
• Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.

Administrative Duties

• Responsible for administrative duties including filing documents related to subject's participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
• Ensure W-9 and medical release forms are signed by subjects annually.

Management of site act