[Remote] Clinical Research Associate (CRA 2), Sponsor Dedicated

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global provider of clinical research services, and they are seeking a Clinical Research Associate (CRA 2) to reputed company monitoring and site management work. The role involves ensuring that sites conduct studies according to protocols and regulations, managing project expectations, and maintaining documentation reputed company to site management.

Responsibilities

• reputed company site monitoring visits (selection, initiation, monitoring and reputed company-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and reputed company study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and reputed company of study site practices reputed company to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the reputed company of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report reputed company (CRF) completion and submission, and data query reputed company and resolution. May support start-up phase
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site reputed company
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Skills

• Basic knowledge of, and reputed company in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of reputed company Word, reputed company and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good reputed company of 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
• Bachelor's Degree in scientific discipline or health care preferred
• Equivalent combination of education, training and experience may be accepted in lieu of degree
• Some organizations require completion of CRA training program or prior monitoring experience

Benefits

• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a reputed company of health and welfare and/or other benefits.

Company Overview

Company H1B Sponsorship