Harvest Technical Services
6917 Study Research Specialist II
Harvest Technical Services, San Rafael, California, United States, 94911
Duties:
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. The company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative therapeutics, advancing the standard of care, and providing personalized support and services globally.The Company's Global Study Operations organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post approval studies and drives the delivery of high-quality data to support the registration approval and post approval activities of our clinical development assets.The organization achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.Role Summary
The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:Core Competencies:
Agility and ProactivityCommunication and CollaborationTechnical competencies:Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area Knowledge
Responsibilities include but are not limited to:Develop and/or review study specific documentation, as delegated by the Study ManagerContribute to the management of country and site feasibility assessmentProvide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sitesContribute to the collection and oversight of essential documents for study life-cycle managementContribute to the development of site and investigator training materialsMay present at investigator meetings as assignedEnsure timely study entry and updates to ClinicalTrials.govEnsure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)Provide administrative assistance with internal and external meetings including investigator meeting(s) as warrantedFacilitate Screening Authorization Forms tracking/sign off where applicableManage various Global Study Operations document translations as applicableProcess documents for signature in DocuSignSite management for delegated site(s)Manage and resolve site related issues and risks escalating to the company that can't be resolved by CRO.Contribute to identifying risks identification and mitigationsOversee the Clinical Trial Insurance processSupport Study Manager to ensure timely delivery and handling of IP to the sitesSupport Vendor ManagementAttend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requiredSkills:
Oversee and manage essential documents in the Trial Master File (TMF)Contribute to Global Study Operations risks identification and mitigations.Provide support and administrative assistance with internal and external meetingsAssist with filing GSO internal study documents in internal systemsEducation & ExperienceBS or higher in nursing, life or health sciences is preferredIndustry or relevant experience in the education may be consideredExperience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
The hiring range for this position is $38 to $45 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or
expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.
#ZR
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. The company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative therapeutics, advancing the standard of care, and providing personalized support and services globally.The Company's Global Study Operations organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post approval studies and drives the delivery of high-quality data to support the registration approval and post approval activities of our clinical development assets.The organization achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.Role Summary
The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:Core Competencies:
Agility and ProactivityCommunication and CollaborationTechnical competencies:Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area Knowledge
Responsibilities include but are not limited to:Develop and/or review study specific documentation, as delegated by the Study ManagerContribute to the management of country and site feasibility assessmentProvide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sitesContribute to the collection and oversight of essential documents for study life-cycle managementContribute to the development of site and investigator training materialsMay present at investigator meetings as assignedEnsure timely study entry and updates to ClinicalTrials.govEnsure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)Provide administrative assistance with internal and external meetings including investigator meeting(s) as warrantedFacilitate Screening Authorization Forms tracking/sign off where applicableManage various Global Study Operations document translations as applicableProcess documents for signature in DocuSignSite management for delegated site(s)Manage and resolve site related issues and risks escalating to the company that can't be resolved by CRO.Contribute to identifying risks identification and mitigationsOversee the Clinical Trial Insurance processSupport Study Manager to ensure timely delivery and handling of IP to the sitesSupport Vendor ManagementAttend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requiredSkills:
Oversee and manage essential documents in the Trial Master File (TMF)Contribute to Global Study Operations risks identification and mitigations.Provide support and administrative assistance with internal and external meetingsAssist with filing GSO internal study documents in internal systemsEducation & ExperienceBS or higher in nursing, life or health sciences is preferredIndustry or relevant experience in the education may be consideredExperience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
The hiring range for this position is $38 to $45 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or
expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.
#ZR