Sr. CRA II
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.
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
Experience in Oncology and Rare Disease
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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
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... For full info follow application link.
