Responsibilities:

• Responsible for site management oversight, clinical monitoring, and central monitoring deliverables
• Oversees site interactions post-activation through site closeout
• May be responsible for identification of critical data and process, protocol execution risks, and risk mitigations
• Reviews the study scope of work, budget, and protocol content
• Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables
• Escalates to the project manager any risks to clinical trial management deliverables
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings
• Serves as an escalation point for communications with investigator site staff
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones
• Responsible for development and ongoing maintenance of clinical study tools and templates
• Coordinates initial and ongoing training to the study team
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct
• Ensures quality of the clinical monitoring, central monitoring, and site management deliverables
• Reviews the project oversight dashboards and other clinical trial systems
• Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan
• Reviews the content and quality of site and central monitoring documentation
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance
• Provides feedback to line managers on staff performance

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Demonstrated ability to lead and align teams in the achievement of project milestones
• Demonstrated capability of working in an international environment
• Demonstrated expertise in site management and monitoring (clinical or central)
• Preferred experience with risk-based monitoring
• Demonstrates understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills
• Good communication, presentation, and interpersonal skills among project team and with sites
• Strong conflict resolution skills
• Demonstrated ability to apply problem-solving techniques to resolve complex issues
• Critical thinking to determine the cause and appropriate solution in the identification of issues
• Moderate travel may be required, approximately 20%

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The successful candidate will be responsible and accountable for the customer-focused leadership and management of SSU deliverables, ensuring delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations.

Key responsibilities include:

• Developing and managing integrated site start-up timelines and reporting progress
• Providing oversight of all project start-up deliverables, including site selection, site activation, and life cycle maintenance
• Collaborating with major functional areas, including Business Development, Alliance Management, and Project Management
• Identifying and evaluating fundamental issues pertaining to Site Start-Up and implementing solutions
• Ensuring all project deliverables meet internal and customer expectations
• Developing and maintaining relationships with customers
• Preparing and presenting overall SSU strategy and status at client meetings
• Reviewing project SSU budget and taking corrective measures to ensure project profitability
• Using professionally recognized tools for planning and management of scope, timeline, and resources

The ideal candidate will have experience in site activation, project management, and regulatory affairs, with excellent communication and leadership skills.

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

Job Data by YubHub.

The Sr CRA will perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits
• Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions
• Verify process of obtaining informed consent has been adequately performed and documented
• Assess factors that might affect subject/patient's safety and clinical data integrity
• Conduct Source Document Review of site source documents and medical records
• Apply query resolution techniques remotely and on-site
• Utilize available hardware and software to support effective conduct of clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Understand project scope, budgets, and timelines for own and others' activities in the clinical team
• Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• Act as primary liaison with project site personnel or in collaboration with Central Monitoring Associate
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards
• May provide training or mentorship to more junior level CRAs

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Job Data by YubHub.