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Clinical Research Associate II (Remote)

Company: PAREXEL
Location: Jersey City
Posted on: November 24, 2022

Job Description:

Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.--- Build relationships with investigators and site staff.--- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.o Conduct remote Qualification Visits (QVs).--- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.--- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.--- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.--- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.--- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.--- Forecast, develop, manage, and revise plans and strategies for:o IRB/IEC and MoH / RA submission/approval,o Site activation,o Patient recruitment & retention.--- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.--- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.Requirements:--- Able to take initiative and work independently, and to proactively seek guidance when necessary.--- Excellent presentation skills.--- Client focused approach to work.--- Ability to interact professionally within a client organization.--- Flexible 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.--- Strong ability to make appropriate decisions in ambiguous situations.--- Willingness to work in a matrix environment and to value the importance of teamwork. Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology#LI-REMOTE

Keywords: PAREXEL, Jersey City , Clinical Research Associate II (Remote), Healthcare , Jersey City, New Jersey

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