Randstad Regulatory in Durham, North Carolina



Durham, NC

Date Posted:

Tuesday, September 27, 2016

Job Type:


Reference #:



Randstad Life Sciences

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Job Title: Regulatory & Start Up Specialist 1

Position Description

  • Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

  • May participate in feasibility and/or site identification activities.

Position Responsibilities

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST.

  • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.

  • Perform Regulatory, Start-up and Maintenance 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.

  • Review, prepare and negotiate site contracts and budgets with sites.

  • 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, including contracts, regulatory and IP Release documents, in line with project timelines.

  • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.

  • Perform quality control of documents provided by sites.

  • May perform Site Selection Visits if a trained monitor. May participate in feasibility and/or site identification activities.

Education & Required Skills:

  • Bachelor s Degree in life sciences or a related field and 1 year s clinical research or other relevant experience; or equivalent combination of education, training and experience.

  • Regulatory Document and Collection experience

  • Informed Consent Review Experience

  • Previous CRO experience preferred

  • In-depth knowledge of clinical systems, procedures, and corporate standards.

  • Effective communication, organizational, planning and interpersonal skills.

  • Ability to work independently and to effectively prioritize tasks. Ability to work on multiple projects.

  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

  • Knowledge of applicable regulatory requirements, SOPs and company s Corporate Standards. Understanding of regulated clinical trial environment and knowledge of drug development process.

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.


  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

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