Clinical Research Associate II (Remote) - Now Hiring

PAREXEL Remote
clinical research research remote qualification regulatory remote judgment strategy site specific iec ra patient recruitment management
December 2, 2022
PAREXEL
Driftwood, TX
FULL_TIME, PART_TIME

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


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