Initiation Clinical Research Associate II

Clinical Site’s main point of contact for assigned sites, accountable for quality and delivery of sites during the pre-SIV / start-up phase. Manages country specific feasibility, site pre-qualification and qualification activities

• 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:

Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.

Conduct remote Qualification Visits (QVs).

• Generate visit/contact reports in accordance with monitoring plans.

• Configure, distribute, collect, 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 required, country/site specific Informed Consent Forms (ICF), translations (in accordance with country/regulatory/client requirements), and any amendments.

• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s) in accordance with country/regulatory/client requirements, following up until receipt of final approval.

• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

• Assist with forecast, development, and management of plans and strategies for:

IRB/IEC and MoH / RA submission/approval,

Site activation

Patient recruitment & retention

• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner, as indicated per project requirements.

• Promptly identify, use judgement and knowledge to address and resolve or escalate (if applicable, to Functional Lead), any site question and/or issue, including but not limited to: study non-compliance, potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity etc.

• Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

• Supports protocol amendments throughout the life of the study as required.

• Maintains a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training. Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.

QualificationsAt minimum, a Bachelor's degree in the field of life sciences or medical sciences. Masters degree preferred. Successful candidates likely to have experience as study coordinator responsible for LEC submissions.