Clinical Research Associate (Hybrid)

Vaachi Systems Inc. - More jobs by this advertiser
Position: Clinical Research Associate (CRA) - HybridVaachi Systems has partnered with a distinguished leader in the life sciences industry, renowned for its innovative analytics, advanced technology solutions, and comprehensive clinical research services. Out client is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their team on a full-time basis. As CRA, you will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. This position offers the flexibility to work onsite and remotely. Essential Functions:Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, in adherence to the contracted scope of work and regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Collaborate with study sites to develop and execute subject recruitment plans aligned with project needs to enhance predictability.Deliver protocol and study-related training to assigned sites and establish regular communication to manage ongoing project expectations and address issues.Evaluate the quality and integrity of study site practices, ensuring compliance with the protocol and applicable regulations, and escalate quality issues as necessary.Manage the progress of assigned studies, including tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query resolution.Ensure the availability of site documents for filing in the Trial Master File (TMF) and verify maintenance of the Investigator's Site File (ISF) in accordance with GCP/ICH and local regulatory requirements.Maintain detailed documentation on site management, monitoring visit findings, and action plans through regular visit reports, follow-up letters, and other necessary study documentation.Collaborate and liaise with study team members to provide project execution support as needed.If applicable, contribute to the development of the project subject recruitment plan on a per-site basis.If applicable, manage site financials according to the executed clinical trial agreement and retrieve invoices in accordance with local requirements.Qualifications:Bachelor's Degree in a scientific discipline or health care preferred. Equivalent combinations of education, training, and experience may be accepted in lieu of a degree.Completion of a CRA training program or prior monitoring experience may be required by some organizations.Basic knowledge and application of clinical research regulatory requirements, including GCP and ICH guidelines.Good therapeutic and protocol knowledge as provided in company training.Proficiency in Microsoft Word, Excel, and PowerPoint, as well as the use of a laptop computer, iPhone, and iPad (where applicable).Strong written and verbal communication skills, including a good command of the English language.Organizational and problem-solving skills.Effective time and financial management skills.Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

11 April 2024
Location: United States Hauts-de-France Durham
Work type:
Full time
PLEASE! No enquiries from Recruitment Agencies or Headhunters.

Only direct applications will be considered.

This career opportunity is no longer open.
Please search for current vacancies here.


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