CRA II -Sponsor dedicated - Southwest
Syneos Health, Inc., Denver, CO, United States
This Clinical Research Associate II – Sponsor Dedicated role focuses on overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a central location. The incumbent conducts remote and on‑site monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols, and supports the overall success of clinical trials.
Job Responsibilities
Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP). Conducts source document review of appropriate site source documents and medical records, verifies required clinical data entered in the case report form (CRF) is accurate and complete, applies query resolution techniques remotely and on‑site, and provides guidance to site staff as necessary.
Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF) and ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Understands project scope, budgets and timelines for assigned activities; manages site‑level activities/communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals/targets.
Acts as primary liaison with study site personnel or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings; participates in global clinical monitoring/project staff meetings and attends clinical training sessions as required.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations and company SOPs/processes; completes assigned training as required.
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 applicable regulatory requirements.
Good computer skills and ability to embrace new technologies.
Excellent communication, presentation and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.
US‑only: Employer may require deployment to sites that need additional personal information for facility access; compliance with site requests is mandatory.
Benefits
Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) matching, employee stock purchase plan, commissions/bonuses, and flexible paid time off and sick leave.
Equal‑Opportunity Employer
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, gender identity, sexual orientation, national origin, or disability. Employees requiring reasonable accommodations will be provided guidance for the application and hiring process.
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Job Responsibilities
Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP). Conducts source document review of appropriate site source documents and medical records, verifies required clinical data entered in the case report form (CRF) is accurate and complete, applies query resolution techniques remotely and on‑site, and provides guidance to site staff as necessary.
Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF) and ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Understands project scope, budgets and timelines for assigned activities; manages site‑level activities/communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals/targets.
Acts as primary liaison with study site personnel or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings; participates in global clinical monitoring/project staff meetings and attends clinical training sessions as required.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations and company SOPs/processes; completes assigned training as required.
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 applicable regulatory requirements.
Good computer skills and ability to embrace new technologies.
Excellent communication, presentation and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.
US‑only: Employer may require deployment to sites that need additional personal information for facility access; compliance with site requests is mandatory.
Benefits
Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) matching, employee stock purchase plan, commissions/bonuses, and flexible paid time off and sick leave.
Equal‑Opportunity Employer
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, gender identity, sexual orientation, national origin, or disability. Employees requiring reasonable accommodations will be provided guidance for the application and hiring process.
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