Syneos Health · 8 hours ago
Freelance CRA Georgia (Europe)
Greater Macon
Full-time
Remote
Senior Level
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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.
Qualification
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Required
Perform monitoring and site management activities for Phase I-IV clinical research projects.
Ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely).
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site.
Conduct Source Document Review of appropriate site source documents and medical records.
Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Document 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.
Understand project scope, budgets, and timelines for own and others’ activities in the clinical team.
Act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
Prepare for and attend Investigator Meetings and/or sponsor face to face meetings.
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
Preferred
May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
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.
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ 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
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Michael Bonello
Chief Financial Officer
Michael Brooks
COO
Recent News
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