Hoag Memorial Hospital Presbyterian
CLINICAL RESEARCH ACTIVATION COORDINATOR - HOAG CENTER FOR CLINICAL RESEARCH
Hoag Memorial Hospital Presbyterian, Newport Beach, California, us, 92659
Salary Range:
$37.3800 - $57.4600 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.
The Clinical Research Activation Coordinator will support and participate in all study startup activities for the Hoag Center for Clinical Research (HCCR) within Hoag Memorial Presbyterian Hospital. This role will collaborate with key stakeholders to ensure all aspects of the study startup process are met including activation timelines, facilitation and communication with internal and external stakeholders.
The coordinator will work closely with the Start-Up Program Manager to support the maintenance of the inventory of status throughout the startup process until internal study activation is granted. This includes working with study teams to closely track and review timelines and key milestones during the start-up phase. This role will support site start-up activities including but not limited to, the review, collection and finalization of Confidentiality Disclosure Agreements Clinical Trial Agreements, Material/Data Transfer Agreements and Disclosure Agreements. This includes corresponding with and providing site level information to sponsors including information about HCCR's feasibility process, SQV's, initial site documentation, budget negotiation, regulatory, and trainings, etc.
This role will interface works closely with sponsors and internal teams to provide the necessary documents/information to meet internal timelines, including studies identified as Rapid Activation trials. This role will support HCCR leaders in identifying and mitigating obstacles for efficient and reduced study activation timelines. Facilitates an efficient review and execution of clinical trial contracts/agreements. Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Communicates project status and improvement areas with leadership in a timely manner. Supports the implementation of department-wide initiatives such as research process improvement efforts. Participates in required training and education programs. Participates in weekly research staff meetings.
Education and ExperienceAt least four years of experience in clinical research regulatory processesBachelor's degree required; Master's degree preferredPrevious experience working with commercial IRBsIn-depth knowledge of clinical oncologyKnowledge of patient electronic medical systems and CTMS or similar systemIn-depth understanding of current medical terminology specific to oncologyFamiliarity with FDA's Good Clinical Practice for clinical researchKnowledge of all components of clinical trials/studiesAbility to travel to multiple sites and attend off-site staff meetings, as needed.Certifications Preferred
Project Management Professional (PMP)SOCRA or ACRP certification
Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.
$37.3800 - $57.4600 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.
The Clinical Research Activation Coordinator will support and participate in all study startup activities for the Hoag Center for Clinical Research (HCCR) within Hoag Memorial Presbyterian Hospital. This role will collaborate with key stakeholders to ensure all aspects of the study startup process are met including activation timelines, facilitation and communication with internal and external stakeholders.
The coordinator will work closely with the Start-Up Program Manager to support the maintenance of the inventory of status throughout the startup process until internal study activation is granted. This includes working with study teams to closely track and review timelines and key milestones during the start-up phase. This role will support site start-up activities including but not limited to, the review, collection and finalization of Confidentiality Disclosure Agreements Clinical Trial Agreements, Material/Data Transfer Agreements and Disclosure Agreements. This includes corresponding with and providing site level information to sponsors including information about HCCR's feasibility process, SQV's, initial site documentation, budget negotiation, regulatory, and trainings, etc.
This role will interface works closely with sponsors and internal teams to provide the necessary documents/information to meet internal timelines, including studies identified as Rapid Activation trials. This role will support HCCR leaders in identifying and mitigating obstacles for efficient and reduced study activation timelines. Facilitates an efficient review and execution of clinical trial contracts/agreements. Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Communicates project status and improvement areas with leadership in a timely manner. Supports the implementation of department-wide initiatives such as research process improvement efforts. Participates in required training and education programs. Participates in weekly research staff meetings.
Education and ExperienceAt least four years of experience in clinical research regulatory processesBachelor's degree required; Master's degree preferredPrevious experience working with commercial IRBsIn-depth knowledge of clinical oncologyKnowledge of patient electronic medical systems and CTMS or similar systemIn-depth understanding of current medical terminology specific to oncologyFamiliarity with FDA's Good Clinical Practice for clinical researchKnowledge of all components of clinical trials/studiesAbility to travel to multiple sites and attend off-site staff meetings, as needed.Certifications Preferred
Project Management Professional (PMP)SOCRA or ACRP certification
Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.