CRA I - Argentina Home Based

Syneos Health; Buenos Aires; Teletrabalho; USD 25.000 - 40.000; Tempo integral

Resumo da oferta

Syneos Health is looking for a CRA I responsible for conducting site qualification and management in Argentina. This home-based role involves ensuring regulatory compliance and supporting clinical research studies. The ideal candidate will possess a relevant degree and strong communication skills to collaborate effectively in a remote environment.

Serviços

Career development programs

Supportive management

Peer recognition

Qualificações

• Bachelor’s degree or RN required.
• Knowledge of ICH-GCP Guidelines.
• Good computer skills and ability to embrace new technologies.

Responsabilidades

• Perform site qualification and management activities, ensuring compliance with applicable standards.
• Document activities and support subject recruitment and retention.
• May act as the primary liaison with project site personnel.

Conhecimentos

Excellent communication

Interpersonal skills

Computer skills

Formação académica

Bachelor’s degree or RN in a related field

Descrição da oferta de emprego

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Description

CRA I - Argentina Home Based

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (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 with guidance 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.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data enteredin the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture o 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.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). 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 in 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.
• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart Abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff
  
  

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Monitoring/CRA at the P20 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes both on-site and remote monitoring, as well as the development of tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributions in a professional or technical discipline, with the possibility of managing two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Impact and Contribution Roles within Clinical Monitoring/CRA at the P20 level play a crucial part in the success of clinical research studies. By ensuring that trials are conducted according to established clinical practices, these roles help maintain the integrity and quality of the research. The development of monitoring tools, procedures, and processes contributes to the overall efficiency and effectiveness of the clinical research program. These roles also support the professional growth of lower-level professionals and the management of processes and programs, thereby contributing to the organization's mission of advancing medical knowledge and improving patient outcomes. Core Focus

• Conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices
• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Supporting the professional growth of lower-level professionals and managing processes and programs
• Ensuring the integrity and quality of clinical research studies through diligent monitoring and adherence to established practices
  
  

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

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