Syneos Health/ inVentiv Health Commercial LLC
Clinical Research Associate II | Oncology - Home-Based
Syneos Health/ inVentiv Health Commercial LLC, New York, New York, us, 10261
Join Syneos Health, a top-tier biopharmaceutical solutions organization that strives to accelerate customer success and transform the clinical landscape. We are a fully integrated organization focusing on innovative solutions to navigate modern market realities.
At Syneos Health, our Clinical Development model revolves around placing customers and patients at the core of our strategies. Our collaborative environment empowers passionate problem solvers to streamline processes, making us not just easy to work with, but also an inspiring workplace.
Our vibrant team of 29,000 employees across 110 countries understands one thing:
WORK HERE MATTERS EVERYWHERE . Why Choose Syneos Health? We are dedicated to your career development and progression with supportive management, extensive training, and a robust rewards program. Embrace our Total Self culture, where authenticity and belonging are prioritized in our global community. We value diversity in thought, background, and perspective, fostering an environment where everyone can thrive. Key Responsibilities: Conduct site qualifications, initiate sites, perform interim and close-out visits—either on-site or remotely—ensuring compliance with regulatory standards and trial protocols. Ensure informed consent is appropriately obtained and documented, maintaining subject confidentiality while identifying any factors that might compromise safety or data integrity. Assess and review site processes, ensuring accurate and complete data entry into case report forms and resolving any discrepancies promptly. Review the Investigator Site File for compliance and accuracy, reconciling it with the Trial Master File as needed. Provide documentation of all activities, including reports and logs in accordance with established SOPs, while supporting subject recruitment and retention efforts. Understand project scope, manage site communications, and adapt to shifting priorities effectively to meet targets. Act as a primary liaison with study site personnel, ensuring compliance and training on project requirements. Participate in Investigator Meetings and training sessions, preparing for audits and ensuring adherence to audit readiness standards. Maintain knowledge of ICH/GCP Guidelines and company SOPs and complete required training. Qualifications: Bachelor's degree or RN in a related field, or a combination of relevant education and experience. Familiarity with Good Clinical Practice and ICH Guidelines. Computer proficiency and enthusiasm for embracing new technologies. Strong communication, presentation, and interpersonal skills. Ability to travel up to 75% regularly. As part of your role with Syneos Health, there may be circumstances requiring you to provide medical and personal information for site access in compliance with our privacy policy. At Syneos Health, we aim to create a supportive environment where our employees can thrive. We offer comprehensive benefits, including health coverage, a company match 401k, stock purchase plan eligibility, performance bonuses, and flexible paid time off. Salary Range:
$70,100.00 - $126,100.00 depending on candidate qualifications. Over the past five years, we have partnered with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, working on over 200 studies worldwide. Join us at Syneos Health, where your contribution makes a difference!
WORK HERE MATTERS EVERYWHERE . Why Choose Syneos Health? We are dedicated to your career development and progression with supportive management, extensive training, and a robust rewards program. Embrace our Total Self culture, where authenticity and belonging are prioritized in our global community. We value diversity in thought, background, and perspective, fostering an environment where everyone can thrive. Key Responsibilities: Conduct site qualifications, initiate sites, perform interim and close-out visits—either on-site or remotely—ensuring compliance with regulatory standards and trial protocols. Ensure informed consent is appropriately obtained and documented, maintaining subject confidentiality while identifying any factors that might compromise safety or data integrity. Assess and review site processes, ensuring accurate and complete data entry into case report forms and resolving any discrepancies promptly. Review the Investigator Site File for compliance and accuracy, reconciling it with the Trial Master File as needed. Provide documentation of all activities, including reports and logs in accordance with established SOPs, while supporting subject recruitment and retention efforts. Understand project scope, manage site communications, and adapt to shifting priorities effectively to meet targets. Act as a primary liaison with study site personnel, ensuring compliance and training on project requirements. Participate in Investigator Meetings and training sessions, preparing for audits and ensuring adherence to audit readiness standards. Maintain knowledge of ICH/GCP Guidelines and company SOPs and complete required training. Qualifications: Bachelor's degree or RN in a related field, or a combination of relevant education and experience. Familiarity with Good Clinical Practice and ICH Guidelines. Computer proficiency and enthusiasm for embracing new technologies. Strong communication, presentation, and interpersonal skills. Ability to travel up to 75% regularly. As part of your role with Syneos Health, there may be circumstances requiring you to provide medical and personal information for site access in compliance with our privacy policy. At Syneos Health, we aim to create a supportive environment where our employees can thrive. We offer comprehensive benefits, including health coverage, a company match 401k, stock purchase plan eligibility, performance bonuses, and flexible paid time off. Salary Range:
$70,100.00 - $126,100.00 depending on candidate qualifications. Over the past five years, we have partnered with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, working on over 200 studies worldwide. Join us at Syneos Health, where your contribution makes a difference!