Syneos Health/ inVentiv Health Commercial LLC
Clinical Research Associate I/II - Sponsor Dedicated - ONC + Gen Med (Home-Based
Syneos Health/ inVentiv Health Commercial LLC, Granite Heights, Wisconsin, United States
Clinical Research Associate I/II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Central 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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.
Job Responsibilities
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluates site and staff performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, regulations, and SOPs/processes.
Verifies informed consent processes are adequately performed and documented; protects confidentiality; assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations/violations, pharmacovigilance issues).
Per CMP/SMP: assesses site processes; conducts source document review of site source documents and medical records; verifies CRF data accuracy/completeness; applies query resolution techniques remotely and on-site; drives query resolution to closure; supports data review and capture; verifies site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensing and administration per protocol; manages issues/risks related to blinded or randomized IP information; ensures IP labelling, import/export in line with GCP/local regulations.
Routinely reviews the Investigator Site File (ISF) for accuracy and completeness; reconciles ISF with Trial Master File (TMF); ensures archiving of essential documents per local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communications logs, and other required project documents; supports subject/patient recruitment and retention; enters data into tracking systems to monitor observations, status and action items.
Understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives; adapts to changing priorities to achieve goals.
May act as primary liaison with study site personnel or with Central Monitoring Associate; ensures all assigned sites and team members are trained and compliant with requirements.
Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and attends training as required.
Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
Maintains working knowledge of ICH/GCP Guidelines and company SOPs; completes required training. For Real World Late Phase, the CRA II may have the Site Management Associate II title with additional responsibilities including lifecycle site support, chart abstraction, collaboration with Sponsor affiliates and LSPs, and potential junior staff training; identify out-of-scope activities and provide input to Lead CRA/Project Manager.
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 regulatory requirements
Strong computer skills and ability to adapt to new technologies
Excellent communication, presentation and interpersonal skills
Ability to travel up to 75% regularly
US ONLY: Employment may involve deployment to sites requiring additional information for facility access. Compliance with site requests is required as a condition of employment. Failure to provide information may bar entry to a site and affect ongoing employment.
Benefits and Additional Information At Syneos Health, we provide an environment and culture for our people to thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) with company match, eligibility for the Employee Stock Purchase Plan, potential bonuses, and flexible PTO and sick time. Paid sick time varies by location in accordance with state and municipal requirements.
Salary Range: The base salary range represents the anticipated low and high for this position. Actual salary varies by candidate qualifications and role requirements.
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 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 listed in this job description are not exhaustive. The Company may assign additional tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes as equivalent qualifications. Nothing herein should be construed as a contract. This text complies with applicable laws and equality directives. The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations where appropriate.
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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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.
Job Responsibilities
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluates site and staff performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, regulations, and SOPs/processes.
Verifies informed consent processes are adequately performed and documented; protects confidentiality; assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations/violations, pharmacovigilance issues).
Per CMP/SMP: assesses site processes; conducts source document review of site source documents and medical records; verifies CRF data accuracy/completeness; applies query resolution techniques remotely and on-site; drives query resolution to closure; supports data review and capture; verifies site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensing and administration per protocol; manages issues/risks related to blinded or randomized IP information; ensures IP labelling, import/export in line with GCP/local regulations.
Routinely reviews the Investigator Site File (ISF) for accuracy and completeness; reconciles ISF with Trial Master File (TMF); ensures archiving of essential documents per local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communications logs, and other required project documents; supports subject/patient recruitment and retention; enters data into tracking systems to monitor observations, status and action items.
Understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives; adapts to changing priorities to achieve goals.
May act as primary liaison with study site personnel or with Central Monitoring Associate; ensures all assigned sites and team members are trained and compliant with requirements.
Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and attends training as required.
Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
Maintains working knowledge of ICH/GCP Guidelines and company SOPs; completes required training. For Real World Late Phase, the CRA II may have the Site Management Associate II title with additional responsibilities including lifecycle site support, chart abstraction, collaboration with Sponsor affiliates and LSPs, and potential junior staff training; identify out-of-scope activities and provide input to Lead CRA/Project Manager.
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 regulatory requirements
Strong computer skills and ability to adapt to new technologies
Excellent communication, presentation and interpersonal skills
Ability to travel up to 75% regularly
US ONLY: Employment may involve deployment to sites requiring additional information for facility access. Compliance with site requests is required as a condition of employment. Failure to provide information may bar entry to a site and affect ongoing employment.
Benefits and Additional Information At Syneos Health, we provide an environment and culture for our people to thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) with company match, eligibility for the Employee Stock Purchase Plan, potential bonuses, and flexible PTO and sick time. Paid sick time varies by location in accordance with state and municipal requirements.
Salary Range: The base salary range represents the anticipated low and high for this position. Actual salary varies by candidate qualifications and role requirements.
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 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 listed in this job description are not exhaustive. The Company may assign additional tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes as equivalent qualifications. Nothing herein should be construed as a contract. This text complies with applicable laws and equality directives. The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations where appropriate.
#J-18808-Ljbffr