Experienced Clinical Research Associate Service - Oncology
Behavioral Health Market Context
Apply Nowvia Learn4Good
Qualifications
- •Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labelled, imported and released/returned
Responsibilities
- •Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
- •Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
- •Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- •Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
- •Demonstrates diligence in protecting the confidentiality of each subject/patient
- •Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- •Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- •Assesses site processes
- •Conducts Source Document Review of appropriate site source documents and medical records
- •Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- •Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- •Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- •Verifies site compliance with electronic data capture requirements
- •May perform investigational product (IP) inventory, reconciliation and reviews storage and security
- •Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
- •Verifies issues or risks associated with blinded or randomized information related to IP
- •Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
- •Reconciles contents of the ISF with the Trial Master File (TMF)
- •Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
- •16 more items(s)
More Jobs
- Clinical Study Managerat Stryker
- Speech Language Pathologist Speech Therapist/SLPat Triage Staffing
- BCBA inat Soliant Health
- Clinical Research Front Desk Specialist - Patient Conciergeat CenExel
- Behavior Technician – Entry-Level Role with Paid Training - Now Hiringat ABS Kids
- Medical Assistant/ Study coordinatorat Proactive Clinical Research, LLC.
- Phlebotomist/Lab Techat Headlands Research
- Patient Transporter PRNat HCA Florida Gulf Coast Hospital
- Board Certified Behavior Analystsat Behavioral Foundation Centers Inc
- Speech-Language Pathologist: Rehab Teamat Liberty Health