Research Project Manager
You
Helix Helix is a place where innovators and doers gather in order to drive significant progress in population genomics. We have come together to work at the intersection of clinical care, research, and genomics. If you're excited by the idea of making a meaningful impact and joining a team where we pride ourselves on driving innovation through fostering an environment with an emphasis on empowering one another to grow, Helix might be the place for you! Helix
The World Our end-to-end population genomics platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into routine clinical care. We support all aspects of population genomics from recruitment to translational research and help our partners use genomics to improve health outcomes, increase patient engagement, and lower costs. Leading health systems, including Renown Health, AdventHealth, and Mayo Clinic, use our population genomics platform to power some of the world's largest and fastest-growing population genomics initiatives. For the COVID-19 public health crisis, Helix has built one of the nation's largest COVID diagnostic labs and has been on the leading edge of national viral surveillance efforts tracking B.1.1.7 and other viral strains. What is special about this role:
The Research Project Manager (RPM) is responsible for assigned day-to-day coordination and overall regulatory management of sponsor activities for assigned Helix studies. Sponsor activities include working together with Partner Success to coordinate study startup and site startup activities, providing training to participating site research staff, regulatory submissions, event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, participating in meetings, and coordinating communication with regulatory authorities, among others. The RPM will work with the Senior Research Manager to report on defined deliverables, to identify issues with planned goals and to develop contingency plans when necessary to keep project milestones on track. The RPM will report to the Senior Research Manager at Helix. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration. As a Research Project Manager, you will be responsible for:
Day-to-day regulatory oversight and management of assigned projects Developing and maintaining Trial Master Files (TMF) Assisting Helix Investigators with protocol and consent form development for initial application , subsequent amendment changes and ongoing continuing review approvals Assisting Member Sites with regulatory questions and provide guidance where needed Initiating, planning, facilitating and overseeing the research project start-up, active and close out phases with Member Sites Maintaining study-related databases and preparing protocol-related reports as needed. Scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks. Required Background:
Bachelor's degree required in a field relevant to clinical research 3
years of experience with research study coordination 1-3 years of experience with research project management working on specimen-based research, including genomic research. Knowledge of regulatory affairs, research ethics and the responsible conduct of research. Demonstrated excellence in attention to detail, organization, communication and interpersonal skills. Demonstrated ability to work independently and balance multiple projects simultaneously. Demonstrated desire to be a strong team player and contribute to a shared team environment. Pluses:
Experience running or participating in a multi-center genetic research study as a project manager
Salary Range:
$80K -- $100K
Minimum Qualification
Technical Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Helix Helix is a place where innovators and doers gather in order to drive significant progress in population genomics. We have come together to work at the intersection of clinical care, research, and genomics. If you're excited by the idea of making a meaningful impact and joining a team where we pride ourselves on driving innovation through fostering an environment with an emphasis on empowering one another to grow, Helix might be the place for you! Helix
The World Our end-to-end population genomics platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into routine clinical care. We support all aspects of population genomics from recruitment to translational research and help our partners use genomics to improve health outcomes, increase patient engagement, and lower costs. Leading health systems, including Renown Health, AdventHealth, and Mayo Clinic, use our population genomics platform to power some of the world's largest and fastest-growing population genomics initiatives. For the COVID-19 public health crisis, Helix has built one of the nation's largest COVID diagnostic labs and has been on the leading edge of national viral surveillance efforts tracking B.1.1.7 and other viral strains. What is special about this role:
The Research Project Manager (RPM) is responsible for assigned day-to-day coordination and overall regulatory management of sponsor activities for assigned Helix studies. Sponsor activities include working together with Partner Success to coordinate study startup and site startup activities, providing training to participating site research staff, regulatory submissions, event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, participating in meetings, and coordinating communication with regulatory authorities, among others. The RPM will work with the Senior Research Manager to report on defined deliverables, to identify issues with planned goals and to develop contingency plans when necessary to keep project milestones on track. The RPM will report to the Senior Research Manager at Helix. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration. As a Research Project Manager, you will be responsible for:
Day-to-day regulatory oversight and management of assigned projects Developing and maintaining Trial Master Files (TMF) Assisting Helix Investigators with protocol and consent form development for initial application , subsequent amendment changes and ongoing continuing review approvals Assisting Member Sites with regulatory questions and provide guidance where needed Initiating, planning, facilitating and overseeing the research project start-up, active and close out phases with Member Sites Maintaining study-related databases and preparing protocol-related reports as needed. Scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks. Required Background:
Bachelor's degree required in a field relevant to clinical research 3
years of experience with research study coordination 1-3 years of experience with research project management working on specimen-based research, including genomic research. Knowledge of regulatory affairs, research ethics and the responsible conduct of research. Demonstrated excellence in attention to detail, organization, communication and interpersonal skills. Demonstrated ability to work independently and balance multiple projects simultaneously. Demonstrated desire to be a strong team player and contribute to a shared team environment. Pluses:
Experience running or participating in a multi-center genetic research study as a project manager
Salary Range:
$80K -- $100K
Minimum Qualification
Technical Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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