Regulatory and Start Up Specialist 1
Job Overview:
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.
With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
May also include maintenance activities.
Essential Functions:
oWith moderate oversight and supervision, serve as a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Review documents for completeness, consistency and accuracy, under guidance of senior staff.
oPrepare site documents, reviewing for completeness and accuracy.
oInform team members of completion of regulatory contractual.
and other documents for individual sites.
oDistribute completed documents to sites and internal project team members.
oUpdate and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
oReview, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
Qualifications:
oBachelor's Degree Life sciences or a related field Req AndoOther 1 - 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.
ReqoWith 3 years' experience in a healthcare environment or equivalent combination of education, training and experience.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Learn more at https:
//jobs.
iqvia.
comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
https:
//jobs.
iqvia.
com/eoe />As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.
https:
//jobs.
iqvia.
com/covid-19-vaccine-status Recommended Skills Clinical Research Databases Health Care Maintenance Networking Performance Management Estimated Salary: $20 to $28 per hour based on qualifications.
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.
With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
May also include maintenance activities.
Essential Functions:
oWith moderate oversight and supervision, serve as a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Review documents for completeness, consistency and accuracy, under guidance of senior staff.
oPrepare site documents, reviewing for completeness and accuracy.
oInform team members of completion of regulatory contractual.
and other documents for individual sites.
oDistribute completed documents to sites and internal project team members.
oUpdate and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
oReview, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
Qualifications:
oBachelor's Degree Life sciences or a related field Req AndoOther 1 - 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.
ReqoWith 3 years' experience in a healthcare environment or equivalent combination of education, training and experience.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Learn more at https:
//jobs.
iqvia.
comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
https:
//jobs.
iqvia.
com/eoe />As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.
https:
//jobs.
iqvia.
com/covid-19-vaccine-status Recommended Skills Clinical Research Databases Health Care Maintenance Networking Performance Management Estimated Salary: $20 to $28 per hour based on qualifications.
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