Senior Clinical Research Associate

1 month ago

Ho Chi Minh City, Vietnam Parexel Full time

The Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues.

Where available an “initiation Clinical Research Associate“ (iCRA) specializing in Pre SIV activities will be assigned & accountable for managing and driving the strategy for the Pre SIV / startup tasks of the study. The iCRA) also support protocol amendments if applicable.
iCRA would review / approve the documents as determined by Parexel SOPs (e.g. SRP & ICF). For studies that use client SOPs, the necessity for the iCRA role will depend on the contracted tasks/procedures; if the iCRA role is not required the CRA will cover all tasks necessary.

**Job Description**:
**Key Accountabilities**:
**Start-up (from site identification through pre-initiatio**n**:
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:

- 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, 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.
- 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:

- 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.
- 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.
- 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.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.

**Maintenance (from initiation through close out)**:
Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
- Build relationships with investigators and site staff.
- Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
- Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
- Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
- Address/evaluate/resolve issues pending from the previous visit, if any.
- Follow-up on and respond to appropriate site related questions.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
- Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
- Conduct remote visits/contacts as requested/needed.
- Generate visit/contact report.
- Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specif

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