Syneos Health, Inc.
CRA II - Sponsor Dedicated - Oncology + CNS (Home-Based - Connecticut)
Syneos Health, Inc., Oklahoma City, Oklahoma, United States
CRA II - Sponsor Dedicated - Oncology + CNS (Home-Based - Connecticut)
Updated: Yesterday
Location: USA-MA-Remote
Job ID: 25102535
Description
CRA II - Sponsor Dedicated - Oncology + CNS (Home-Based - Connecticut)
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 make Syneos Health easier to work with and easier to work for.
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.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records, verifies required clinical data entered in the CRF is accurate and complete.
May perform 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.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
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.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables, and timelines are met.
May act as primary liaison with study site personnel, ensuring 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, participating in global clinical monitoring/project staff meetings and attending clinical training sessions according to the project specific requirements.
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.
Must demonstrate good computer skills and be able 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: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access.
Salary Range
$70,100.00 - $126,100.00
Get to know Syneos Health
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at jobs@syneoshealth.com.
Phone: 919 876 9300
Fax: 919 876 9360
Toll-Free: 866 462 7373
#J-18808-Ljbffr
Location: USA-MA-Remote
Job ID: 25102535
Description
CRA II - Sponsor Dedicated - Oncology + CNS (Home-Based - Connecticut)
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 make Syneos Health easier to work with and easier to work for.
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.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records, verifies required clinical data entered in the CRF is accurate and complete.
May perform 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.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
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.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables, and timelines are met.
May act as primary liaison with study site personnel, ensuring 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, participating in global clinical monitoring/project staff meetings and attending clinical training sessions according to the project specific requirements.
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.
Must demonstrate good computer skills and be able 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: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access.
Salary Range
$70,100.00 - $126,100.00
Get to know Syneos Health
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at jobs@syneoshealth.com.
Phone: 919 876 9300
Fax: 919 876 9360
Toll-Free: 866 462 7373
#J-18808-Ljbffr