Initiation Clinical Research Associate II

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal to improve the worlds 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 were committed to making a difference.

Key Accountabilities:

Startup (from site identification through preinitiation):

Act as Parexels direct point of contact with assigned sites accountable for quality and delivery during the startup phase.

• Build relationships with investigators and site staff.

• Conduct drive and manage country specific feasibility and/or site prequalification and qualification activities which may include:

Preparation negotiation and facilitation of 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 noncompliance 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 selfdriven capacity with limited need for oversight.

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

Maintenance (from initiation through close out):

Act as Parexels direct contact with assigned sites assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites and perform problemsolving 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 onsite staff assignment is still accurate and determine and implement corrective actions & followup 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.

• Followup 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 followup 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 onsite 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 sitespecific 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 & followup site payment status.

• Followup on CRF data entry query status and SAEs.

• Conduct onsite studyspecific training (if applicable).

• Perform site facilities assessments

• Recognize impact of study noncompliance/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.

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 ongoing maintenance for completeness and quality.

• Ensure that assigned sites are audit and inspection ready

• Monitor and maintain compliance with ICHGCP 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 resultsorientated 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 ICHGCP 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 selfdriven capacity with limited need for oversight.

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

Skills:

• Sound problem solving skills.

• Able to take initiative and work independently and to proactively seek guidance when necessary.

• Advance 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.

• 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 MSOffice products such as Excel and Word.

• Strong interpersonal verbal and written communication skills.

• Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.

• Effective time management in order to meet study needs team objectives and department goals.

• Developing 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.

• Attention to detail.

• Holds a drivers license where required

Knowledge and Experience:

• 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 healthrelated discipline preferred) or equivalent nursing qualification or other equivalent experience