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- 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.
- 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.
- Some interoffice travel may be required with use of company vehicle or mileage reimbursement
- Associates or Bachelor's degree in healthcare, clinical research management, or related required.
- Master's degree or study-specific training preferred
- 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
- Health, Dental, Vision (with HSA plans and employer contribution)
- PTO
- Sick Time
- 401K with company match
- Short & Long Term Disability
- Educational Assistance
- Shared company vehicles for required travel
Clinical Research Coordinator II - Peoria, United States - Arizona Liver Health
Description
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 position in Peoria.
Title: Clinical Research Coordinator II (CRC2)
Compensation: Depending on experience
Status: Full-time, Non-exempt
Essential job functions/duties:
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
EEO statement
It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.
Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.