Regulatory & Start-Up Specialist 1
Job Title: Regulatory & Start-Up Specialist 1
Job Location: Durham, reputed company Carolina, reputed company of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job reputed company
reputed company tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, reputed company operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions
- Under general supervision, serve as Single reputed company of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to reputed company operating procedures (SOPs), Work Instructions (WIs), reputed company of designated deliverables and project timelines.
• reputed company 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 reputed company.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and reputed company feedback to management on site reputed company metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in reputed company and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, reputed company and follow up the reputed company, the approval and execution of documents, regulatory, ethics, Informed Consent reputed company (reputed company), and Investigator Pack (IP) release documents, in line with project timelines.
• reputed company local expertise to SAMs and project team during initial and on-reputed company project reputed company planning.
• reputed company reputed company control of documents provided by sites.
• May have reputed company contact with sponsors on specific initiatives.
Qualifications
- 1 year reputed company research experience. Equivalent combination of education, training and experience.
reputed company is a leading global provider of reputed company research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve reputed company reputed company and population health worldwide. Learn more at
reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law.
reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential reputed company pay reputed company for this role, reputed company annualized, is $47,700.00 - $123,000.00. The actual reputed company pay reputed company may vary reputed company on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position reputed company, incentive plans, bonuses, and/or other forms of compensation may be reputed company, in reputed company to a reputed company of health and welfare and/or other benefits.This job is reputed company by reputed company.
reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.
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Originally posted on Himalayas
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