Clinical Research Associate - Fsp (Talca)

Join to apply for the Clinical Research Associate - FSP role at Parexel1 day ago Be among the first 25 applicantsJoin to apply for the Clinical Research Associate - FSP role at ParexelGet AI-powered advice on this job and more exclusive features.Parexel is looking for multiple CRAs with 1+ year of experience in Chile! The Clinical Research Associate will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements. The Clinical Research Associate will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.Key AccountabilitiesMaintenance (from initiation through close out) : Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.Build relationships with investigators and site staff.Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.Address / evaluate / resolve issues pending from the previous visit, if any.Follow-up on and respond to appropriate site related questions.Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.Collect, review, and approve (if applicable) updated / amended site documentation, including regulatory documents as applicable.Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.Conduct remote visits / contacts as requested / needed.Generate visit / contact report.Evaluate overall compliance and performance of sites and site staff : provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.Assess & manage test article / study supply including supply, accountability and destruction / return status.Review & follow-up site payment status.Follow-up on CRF data entry, query status, and SAEs.Conduct on-site study-specific training (if applicable). Perform site facilities assessmentsRecognize impact of study non-compliance / issues / delays / changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution.Overall Accountabilities From Site Identification To Close OutEnsure timely and accurate completion of project goals and update of applicable trial management systems.Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.Ensure that assigned sites are audit and inspection readyMonitor and maintain compliance with ICH-GCP and applicable international and local regulations.Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.Show commitment and perform consistent high-quality work.Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.Provide input and feedback for Performance Development Conversation(s). Proactively keep manager informed about work progress and any issues.Develop expertise to become a subject matter expert.Work in a self-driven capacity, with limited need for oversight.Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)SkillsSound problem solving skills.Able to take initiative and work independently, and to proactively seek guidance when necessary.Advance presentation skills.Client focused approach to work.Ability to interact professionally within a client organization.Adaptable attitude with respect to work assignments and new learning.Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.Willingness to work in a matrix environment and to value the importance of teamwork.Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.Strong interpersonal, verbal, and written communication skills.Sense of urgency in completing assigned tasks and ability to assist others to meet study / country deliverables and preserving patient safety.Effective time management in order to meet study needs, team objectives, and department goals.Developing ability to work across cultures.Shows commitment to and performs consistently high-quality work.Ability to successfully work in a ('virtual') team environment.Consulting SkillsGreat attention to detail.Able to accommodate extensive travel time requirements, according to tasks allocation / phase of the study assigned.Holds a driver's license where required.Knowledge And ExperienceFor the Clinical Research Associate a mininum of 1 year as a clinical monitor with demonstrated experience of monitoring (virtual & onsite). EducationEducated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experienceProficiency in local language preferred. English is requiredSeniority levelSeniority levelEntry levelEmployment typeEmployment typeFull-timeJob functionJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health CareReferrals increase your chances of interviewing at Parexel by 2xSign in to set job alerts for "Clinical Research Associate" roles.Specialist, Regulatory and Site Activation - Mexico- RemoteSantiago, Santiago Metropolitan Region, Chile 1 month agoSantiago, Santiago Metropolitan Region, Chile 1 month agoCRA II or Sr CRA assigned to client Mexico, Chile, Colombia, Brazil, ArgentinaSite Activation Specialist assigned to client Mexico, Chile, Colombia, Brazil, ArgentinaRemote Administrative Assistant – Operations & Research SupportSenior Clinical Trial Project Manager – ChileWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-

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