Senior Clinical Research Associate

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.

This may include various tasks and roles within the CRA framework, contingent upon project phase and country demands, and complexity of the study. The Clinical Research Associate will oversee the conduct of the trial at designated sites, ensuring the rights and well-being of human subjects are protected, evaluating the quality and integrity of the reported data, evaluating the site efficacy of staff training and requiring retraining where necessary, developing strategy regarding patient recruitment, evaluating and building the relationship with the clinical site, using problem-solving to promote positive working relationships with the site and staff, and ensuring the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).

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.

In Japan for studies that are using Parexel SOPs, prior to SIV the iCRA will be responsible for preparing the initial site related IRB application and associated documents required prior to SIV as delegated by CRA, and reviewing and approving all essential documents (SRP, ICF etc.). Post SIV the 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.

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 projects 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.)

Skills:

• Strong problem-solving skills
• 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.
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
• Excellent interpersonal, verbal, and written communication skills.
• Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.
• Excellent time management to meet study needs, team objectives, and department goals.
• Proven ability to work across cultures.
• Shows commitment to and performs consistently high-quality work.
• Ability to successfully work in a (‘virtual’) team environment.
• Consulting Skills.
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
• Act as a mentor and role model for other team members.
• Effectively enlist the support of team members in meeting goals.
• Attention to detail.
• Holds a driver’s license where required.

Knowledge and Experience:

• Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.