Candidates must be located in Central or Northeast US.
Job Summary:
The Clinical Research Associate will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Clinical Research Associate will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).
Key Accountabilities:
Oversight of Monitoring Responsibilities and Study Conduct:
Ensuring regulatory, ICH-GCP 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 significant 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 Standard Operating Procedures (SOPs)/processes
Immediately communicates and escalates significant issues to the project team and develops action plans
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required
Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues
Per the Clinical Monitoring Plan (CMP) or SMP: ?Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
Conducts source document review and verification of appropriate site source documents and medical records o Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
Manages reporting of protocol deviations and appropriate follow up
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines? o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture?
May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP
Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released and returned?; Manages reporting of identified issues and manages follow up to resolution Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
Ensures all activities are managed by site personnel who are appropriately delegated and trained
Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution o For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. ?Must be able to quickly adapt to changing priorities to achieve goals and targets
Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
Conducts follow up for escalated adverse event monitoring (AEM) report query
Checks the site and external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log)
Collaboration:
Collaborates with primary Site Manager who will act as the primary liaison with site personnel
Prepares for and attends Investigator Meetings and sponsor face to face meetings.
Participates in global clinical monitoring and project staff meetings (inclusive of client representation, as applicable) and attends clinical training sessions according to the project specific requirements
Process, Standards, and Oversight:
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow up actions
May mentor Site Monitor I (SM I) to support their development and utilization of monitoring systems and processes
Knowledge and Experience:
A minimum of 1 year experience as a clinical monitor (CRA) with demonstrated experience of monitoring (virtual and onsite)
Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence)
Experience in managing complex protocols in Oncology or other therapeutic areas (TA's) where protocols are determined to be high risk
Education:
Bachelor's degree or Registered Nurse (RN) required
LI-CF1
LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
