Sr. Clinical Research Associate

Legacy Foundation•Miami, FL

60d•Remote

About The Position

Job purpose The Senior Clinical Research Associate will be responsible for leading study operational strategy and planning and overseeing the execution of clinical studies for the organization. 1. Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCPs, Protocol and compliance and with study specific Monitoring Plan. Evaluates overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOP)/processes. 2. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject, as appropriate. Demonstrates diligence in protecting the confidentiality of each subject. Assesses factors that might affect subject's safety and clinical data integrity at an investigator site such as Protocol issues. 3. Conducts Source Document Review of appropriate site source documents and medical records. 4. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. 5. Applies query resolution techniques and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. 6. Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture. 7. Verifies site compliance with electronic data capture (EDC) requirements. 8. Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies IP has been dispensed and administered to subjects according to the Protocol. 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 released/returned. 9. Routinely reviews the Investigator Site File (ISF) for accuracy and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator site is aware of the requirements of archiving essential documents in accordance with local guidelines and regulations. 10. Documents activities via confirmation / follow-up letters, trip reports and other required project documents per SOPs, Monitoring Plan and Protocol. Supports subject recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. 11. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to adapt quickly, with the oversight of the Director, Clinical Research, to changing priorities to achieve goals / targets. 12. Acts as primary liaison with site personnel, or in collaboration with other department personnel. Ensures all assigned sites and project-specific team members are trained and compliant with applicable requirements. 13. Prepares for and attends Investigator Meetings and/or face-to-face meetings. Participates in Clinical department/project staff meetings, as needed. 14. Creates clinical project documents according to the Protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports. 15. Provides study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines. 16. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. 17. Assists with the training of newly hired Clinical Research Associates (CRAs). 18. Supports with the preparation of IRB applications, including Protocol and informed consents. 19. Other duties as required.

Requirements

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.
Must have the functional and technical knowledge along with the skills to do the job at a high level of accomplishment.
Possess ability to solve difficult problems with effective solutions.
Takes a leadership role in developing monitoring organization characterized by process standardization, best practice sharing, and continuous improvement.
Bachelor's degree and 6 years as a Clinical Research Associate OR
Associate's degree and 8 years as a Clinical Research Associate OR
High School Graduate and/or technical degree and 10 years as a Clinical Research Associate.
Prior participation in clinical projects as a Lead/Senior Monitor.
Full working proficiency in English.
Proficiency in MS Office applications.
Ability to plan, multi-task and work in a dynamic team environment.
Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills.

Nice To Haves

Clinical Research certification preferred, but not required.
Experience in more than one therapeutic area is advantageous.

Responsibilities

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCPs, Protocol and compliance and with study specific Monitoring Plan.
Evaluates overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately escalates serious issues to the project team and with guidance develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOP)/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject, as appropriate.
Demonstrates diligence in protecting the confidentiality of each subject.
Assesses factors that might affect subject's safety and clinical data integrity at an investigator site such as Protocol issues.
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 and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
Verifies site compliance with electronic data capture (EDC) requirements.
Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
Verifies IP has been dispensed and administered to subjects according to the Protocol.
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 released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF).
Ensures the investigator site is aware of the requirements of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation / follow-up letters, trip reports and other required project documents per SOPs, Monitoring Plan and Protocol.
Supports subject recruitment, retention and awareness strategies.
Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
Must be able to adapt quickly, with the oversight of the Director, Clinical Research, to changing priorities to achieve goals / targets.
Acts as primary liaison with site personnel, or in collaboration with other department personnel.
Ensures all assigned sites and project-specific team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or face-to-face meetings.
Participates in Clinical department/project staff meetings, as needed.
Creates clinical project documents according to the Protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.
Provides study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Assists with the training of newly hired Clinical Research Associates (CRAs).
Supports with the preparation of IRB applications, including Protocol and informed consents.
Other duties as required.