Clinical Research Associate
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Job Description
Summary The CRA is an important member of the reputed company Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing reputed company, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with reputed company CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-reputed company issues.
Job Description
KEY RESPONSABILITIES Provides guidance, reputed company, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring reputed company issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and reputed company-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-reputed company problems, resolutions, actions taken, protocol deviations, study reputed company, and enrollment status. Ensures reputed company of CRF data through meticulous and thorough reputed company document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Participates in internal, client/sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with reputed company documentation and CRFs. Works closely with in-house CRAs/reputed company and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Participates in internal, client/sponsor, scientific, and other meetings as required. Assists in CRA new hire training and reputed company. Performs CRA mentoring. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Manages and resolves conflicting priorities to deliver on commitments. Performs additional duties as assigned. Compensation: $85,000 - 125,000 commensurate with experience DESIRED QUALIFICATION & EXPERIENCE EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment reputed company to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve reputed company or ambiguous challenges Strong reputed company of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular Salary reputed company The final offer will be determined reputed company the applicable location-specific reputed company and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. Apply To This Job