Site Monitor (Argentina) - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring a Site Monitor to support the Argentina region.

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements.The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.

Key Accountabilities:

Start-up (from site identification through pre-initiation):

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.

• 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:

-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.

• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

• 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.

• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

• 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-specific actions and use judgment and experience to assess the ability and motivation of site staff.

• Assess & manage test article/study supply including supply, accountability and destruction/return status.

• Review & follow-up site payment status.

• Follow-up on CRF data entry, query status, and SAEs.

• Conduct on-site study-specific training (if applicable).

• Perform site facilities assessments

• Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Overall Accountabilities from Site Identification to Close out:

Ensure timely and accurate completion of project goals and update of applicable trial management systems.

• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.

• Ensure that assigned sites are audit and inspection ready

• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

• Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.

• Show commitment and perform consistent high quality work.

• Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.

• Maintain 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.

• Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

• Provide input and feedback for Performance Development Conversation(s).

• Proactively keep manager informed about work progress and any issues.

• Develop expertise to become a subject matter expert.

• Work in a self-driven capacity, with limited need for oversight.

• Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Education

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Proficiency in local language preferred. English is required

Experience

• A minimum of 12 months experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite).