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Arizona Liver Health · 2 months ago

Clinical Research Coordinator II/III

Chandler, AZ

Full-time

Onsite

Mid, Senior Level

$27.50/hr - $36/hr

2+ years exp

Arizona Liver Health (ALH) is dedicated to advancing medical innovation through leading clinical trials. They are seeking a Clinical Research Coordinator II/III to manage clinical research activities, ensuring compliance with protocols and regulatory requirements while providing support to patients and staff.

Clinical TrialsHealth CareHospitalityMedical

Responsibilities

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

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 activities during audits and inspections

Management of ancillary staff as assigned

Train and supervise support staff (e.g., CRC I)

Mentor for externs

Train newly hired employees as either Research Assistant and/or CRC

Prepare for quality assurance audits and regulatory inspections as needed

Act as contact person before, during and after audits and inspections

Provide all required documentation to auditors

Make all appropriate corrections as requested by auditors

Coordinate site response to audit/inspection findings

Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner

Other responsibilities as delegated by manager

Qualification

Clinical Research CoordinationGCP CertificationRegulatory ComplianceData ManagementPatient RecruitmentPhlebotomyMedical TerminologyInterpersonal SkillsCommunication SkillsTeam Management

Required

Minimum (2) years of experience working previously as a Clinical Research Coordinator for late phase clinical trials

Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management)

A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics

Interpersonal and communication skills—interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources

Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility protocol deviations, serious adverse events and other reporting requirements

Able to perform all Job duties listed for Job Description for Phlebotomist

Know and understand all regulatory requirements associated with the conduct of the study assigned

Associates or Bachelor's degree in healthcare, clinical research management, or related required

GCP certification required at hire

Experience and training in the conduct of clinical research and basic knowledge of medical terminology

Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management)

Experience with data management and tracking software