AIXIAL GROUP · 3 days ago
Sr. Clinical Research Associate (Sr. CRA) - Contractor (CON11NC315)
United States
Full-time, Contract
Remote
Senior Level
5+ years expAixial Group is an International Contract Research Organization (CRO) that supports biotech in clinical trials across all phases. They are seeking a contract Sr. Clinical Research Associate responsible for site management and monitoring activities associated with clinical studies, ensuring adherence to regulatory requirements and project plans.
Clinical TrialsMedicalTherapeutics
Responsibilities
Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements and appropriate SOPs
Confirm investigator adherence to ICH GCP, local regulatory requirements and to the protocol procedures
Adhere to the project plans, as applicable, for assigned studies
Complete and submit timely site visit reports per the monitoring plan/SOPs
Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting
Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff
Discuss, review, and document patient recruitment strategies with assigned sites
Work with Project Leader (PL), and/or Clinical Team Lead (CTL)/Clinical Trial Manager (CTM) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan
Support assigned sites with vendor issues (e.g., Central Laboratory, IXRS, imaging, etc.) as they arise
Provide any additional training as identified throughout the study (e.g., protocol amendment, query trends) to site staff as needed
Work with site staff on timely data entry and query resolution
Assist in the development of study related trackers and monitoring tools as requested
Review, in conjunction with Clinical and/or Data Managers, the quality and integrity of the clinical data through source data review, source data verification, and inhouse review of electronic CRF data
Liaise with Data Management during all stages of a study to assist with query resolution as required
Assist the PL, and/or CTM/CTL with updating study metrics and compiling status reports
Assist with training of CRAs
Participate in study team meetings as required
May lead CRA meetings, if required
Co-monitor as needed
Perform onsite or remote visits to assess CRA performance
Provide additional support to Clinical Operations staff as needed
Participate in department initiatives to enhance Clinical Operations
Qualification
Required
Bachelor's (or equivalent) degree in science, medical health, or related discipline or equivalent relevant experience
A minimum five years of clinical monitoring experience in the Pharmaceutical/CRO industry
Good clinical and therapeutic knowledge with understanding of medical and pharmaceutical industry terminology
Excellent oral and written communication skills
Strong knowledge of ICH GCP guidelines and applicable regulations
An understanding of physiology, pharmacology, clinical study objectives and the drug development process
Excellent computer skills
Skills in working with Microsoft Office products, particularly Word, Excel, PowerPoint
Preferred
Medical professional with experience in clinical research
Experience in oncology and/or rare disease clinical research
Proactive problem-solving skills
Interpersonal and organizational skills with strong attention to detail
Company
AIXIAL GROUP
Aixial Group is a clinical research organization specializing in life sciences and clinical trials.
Founded in 2004Boulogne-billancourt, Ile-de-France, FRA
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ilana Benaroyo
Global Talent Acquisition Partner
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