Sr. CRA II - Sponsor Dedicated | Cell & Gene Therapy (Home-Based, Northeastern US)

Description Sr. CRA II - Sponsor Dedicated | Cell & Gene Therapy (Home-Based, Northeastern US) Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documents
• Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures
• Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages
• Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities
• Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise
• Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders
• Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases
• Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
• Collaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialists

Qualifications:

• Bachelor's degree in a related field
• Minimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA I
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong scientific background
• Strong experience in Cell & Gene Therapy

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Proficiency in clinical trial management systems and software
• Ability to manage multiple projects and priorities
• Strong attention to detail and organizational skills
• Ability to travel as required for on-site monitoring
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Summary

Roles within Clinical Monitoring/CRA job family at the P22 level are responsible for monitoring clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Impact and Contribution Roles within Clinical Monitoring/CRA job family at the P22 level have a significant impact on the success of clinical research studies. They ensure that clinical projects are conducted, recorded, and reported in accordance with protocols, company and sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. These roles contribute to the overall quality and integrity of clinical data, protect the confidentiality of subjects/patients, and assess factors that might affect subject/patient safety and clinical data integrity. They also provide recommendations regarding site-specific actions, communicate serious issues to the project team, and develop action plans. Additionally, these roles may assume clinical functional leadership tasks, act as primary liaison with study site personnel, and provide guidance at the site and project level towards audit readiness standards. Core Focus

• Ensure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visits
• Evaluate overall performance of site and site staff, provide recommendations regarding site-specific actions, and communicate serious issues to the project team
• Verify the process of obtaining informed consent, protect the confidentiality of subjects/patients, and assess factors affecting subject/patient safety and clinical data integrity
• Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques
• Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security
• Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF)
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met
• Act as primary liaison with study site personnel, ensure training and compliance with applicable requirements, and provide guidance towards audit readiness standards
• Provide direct supervision, training, and mentorship to junior level CRAs

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