[Remote] reputed company Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global team dedicated to innovation and initiative, and they are seeking a reputed company Clinical Research Associate. The reputed company CRA will reputed company reputed company and leadership in managing clinical trial monitoring, ensuring compliance and reputed company while collaborating with various stakeholders.
Responsibilities
- Provides guidance, reputed company, and feedback to the field CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
- Ensures reputed company of data is in line with clinical standards and that the rights and safety of patients involved in studies are protected
- Monitors performance of CRAs on a reputed company reputed company, including reviewing monitoring visit reports and conducting co-monitoring reputed company as needed
- Performs CRA mentoring and reputed company of CRA activities including evaluation of reputed company of work through co-monitoring
- Ensures appropriate and reputed company investigator site reputed company
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue reputed company for clinical trial monitoring reputed company issues
- Assists in development of study-specific Clinical Monitoring Plans and training presentations as needed
- Assists in resourcing CRAs for planned and ongoing clinical trials
- Supports CRA hiring through initial screening, phone, and video interviews of potential new employees
- Responsible for CRA new hire training and reputed company
- Conducts review of CRA time and expenses, as appropriate
- Provides monthly billing information to finance team
- Performs qualification, initiation, interim, and reputed company-out reputed company both onsite and remote, ensuring reputed company documentation of monitoring reputed company
- Prepares consistently accurate and reputed company 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
- Conducts investigational product accountability
- Reviews site regulatory binder for required documents, performing reputed company assurance of documents collected at sites for uploading to eTMF/TMF
- 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
- Proactively identifies site issues and develops problem-solving strategies
- Conducts audit preparation at study sites as needed
- Supports study team with set-up, collection of site specific ethics documents and site contract negotiation as required
- Participates and attends bid defense meetings as required
- Supports improvement and set up of new company processes/procedures reputed company to monitoring activities
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS)
- Promote a reputed company team atmosphere between CRAs
- Participates in internal, reputed company/sponsor, scientific, and other meetings as required
- Performs additional duties as assigned
Skills
- BS/BA from an undergraduate program (life sciences or reputed company discipline preferred)
- 4 years of experience in the pharmaceutical / biotechnology / CRO industry
- 2 years' experience in clinical monitoring with 1 year of management experience
- Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 (for EU applicants)
- Extensive experience in clinical monitoring, in local and international studies, multiple therapeutical areas and phases
- Excellent knowledge of clinical research, ICH GCP, regulatory, ethical and local regulations
- Proven ability to be careful, thorough, detail-oriented and reputed company reputed company
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; reputed company to manage priorities and organize time
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to problem-solve reputed company or ambiguous challenges
- Strong reputed company of English, both written and verbal
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, with ability to use CTMS systems, clinical trial databases and electronic data capture
- Ability to travel
- reputed company, trustworthy and disciplined
- reputed company to manage stress and conflicts
- Leadership attitude
- Problem solving skills
- Self-starter who thrives in a reputed company, yet less reputed company team environment
- Permanent authorization to work in the U.S. (for US applicants)
- Graduation in a scientific/health field
- Experience in clinical project management is not mandatory but is considered as a plus
- Knowledge of Pharmacovigilance processes
- Adequate English
reputed company