Syneos Health · 2 hours ago
CRA II/ Sr CRA- Central Region
Urbana-Champaign Area
Full-time
Remote
Mid, Senior Level
$81K/yr - $145K/yr
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Responsibilities
Performs site qualification, site initiation, interim monitoring, site management 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 via review of site source documents and medical records
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. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
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.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:
Site support throughout the study lifecycle from site identification through close out
Knowledge of local requirements for real world late phase study designs
Chart abstraction activities and data collection
As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
Identify and communicate out of scope activities to Lead CRA/Project Manager
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings
Qualification
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Required
Experience in site qualification, site initiation, interim monitoring, site management and close-out visits.
Knowledge of regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Ability to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions.
Working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Experience in obtaining informed consent and protecting the confidentiality of subjects/patients.
Ability to assess factors affecting subject/patient safety and clinical data integrity.
Experience in conducting Source Document Review and verifying clinical data accuracy.
Ability to apply query resolution techniques and provide guidance to site staff.
Experience with electronic data capture requirements.
Ability to perform investigational product (IP) inventory and reconciliation.
Experience in reviewing the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Ability to document activities via confirmation letters, follow-up letters, trip reports, and other required project documents.
Understanding of project scope, budgets, and timelines.
Ability to manage site-level activities and communication.
Experience in preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings.
Ability to provide guidance towards audit readiness standards.
Experience in training or mentoring junior level CRAs.
Ability to collaborate and build relationships with Sponsor and other affiliates.
Preferred
Experience in Real World Late Phase (RWLP) studies.
Knowledge of local requirements for real world late phase study designs.
Experience in chart abstraction activities and data collection.
Ability to identify operational efficiencies and process improvements.
Experience in developing country level informed consent forms.
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10,001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (40)
2022 (45)
2021 (88)
2020 (76)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity· undefined
2023-05-10Acquired· undefined
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Michael Bonello
Chief Financial Officer
Michael Brooks
COO
Recent News
Triangle Business Journal
2024-01-19
Company data provided by crunchbase
