Senior Clinical Research Associate Job at Parexel (Remote)

Job Description

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.

Job Responsibility

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
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
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
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
For assigned activities, understands project scope, budgets, and timelines
manages site level activities and communication to ensure project objectives, deliverables and timelines are met
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 queries
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)
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 clinic

Requirements

Experience in oncology trials and RECIST criteria is essential
Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders
Proficiency in local language is required
Fluency in English is required

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

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