Regulatory & Start Up Specialist 1 at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalIndustries

Requirements

2 years clinical research experience (or equivalent combination of education, training, and experience)
Bachelor's Degree

Responsibilities

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, ensuring adherence to SOPs, Work Instructions (WIs), quality of 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 plans as needed
Inform team members of completion of regulatory and contractual documents for individual sites
Review, track, and follow up on the progress, approval, and execution of documents, including 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

Skills

Key technologies and capabilities for this role

Site ActivationRegulatory DocumentsSOPsClinical ResearchProject TimelinesQuality ControlInformed Consent FormInvestigator PackEthics ApprovalTracking Tools

Questions & Answers

Common questions about this position

What is the salary range for this position?

The potential base pay range for this role, when annualized, is $46,200.00 - $118,600.00. The actual base pay offered may vary based on factors including job-related qualifications, location, and schedule.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What qualifications are required for this role?

Candidates need a Bachelor's Degree and 2 years of clinical research experience, or an equivalent combination of education, training, and experience.

What is the company culture like at IQVIA?

This information is not specified in the job description.

What makes a strong candidate for this Regulatory & Start Up Specialist role?

Strong candidates will have a Bachelor's Degree, 2 years of clinical research experience (or equivalent), and skills in site activation activities, regulatory document preparation, and adherence to SOPs and timelines.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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