64 applicants

Company

IQVIA · 14 hours ago

Regulatory & Start-Up Specialist

Durham, NC

Full-time

Remote

Entry Level

$55K/yr - $92K/yr

1+ years exp

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AnalyticsHealth Care

H1B Sponsor Likely

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Responsibilities

Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

Prepare site regulatory documents, reviewing for completeness and accuracy.

Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

Review and provide feedback to management on site performance metrics.

Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.

Inform team members of completion of regulatory and contractual documents for individual sites.

Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

Perform quality control of documents provided by sites.

May have direct contact with sponsors on specific initiatives.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical research experienceSite Activation activitiesRegulatory document preparationProject planningQuality control of documents

Required

1 year clinical research experience. Equivalent combination of education, training and experience.

Company

IQVIA

Glassdoor

3.9

IQVIA provides analytics, compliance, and management solutions to the life sciences industry.

Founded in 1982

Danbury, Connecticut, USA

10001+ employees

https://www.iqvia.com

H1B Sponsorship

IQVIA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (218)

2022 (199)

2021 (286)

2020 (197)