Senior Clinical Research Associate - Sponsor Dedicated - Rare Disease (Home-Based in Western US)

Syneos Health, Inc•Morrisville, NC

41d•Remote

About The Position

Senior Clinical Research Associate - Sponsor Dedicated - Rare Disease (Home-Based in Western US) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. 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

Requirements

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
Experience in Oncology and Rare Disease
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

Nice To Haves

Certified Clinical Research Associate (CCRA) or equivalent certification preferred

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

Benefits

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.

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