Site Activation & Regulatory Affairs Lead (US/Remote)

Location: North Carolina, United States

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Requisition Number: 763

Position Title: Site Activation Specialist I

External Description:

The Site Activation and Regulatory Affairs Lead is accountable for end-to-end site activation and regulatory activities for assigned projects and responsible for assigned projects and activities of the Site Activation department.  This includes coordinating and overseeing site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study-specific requirements or activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). It may also include proposal and budget management or feasibility/site identification activities.

RESPONSIBILITIES:

Tasks may include but are not limited to: 

  • Serve as the primary point of accountability and contact for all start-up activities on assigned projects
  • Coordinate and drive the activities of the Site Activation to achieve on-time site activations
  • Provide knowledgeable regulatory advice and contribute to regulatory project work
  • Oversee the activities of assigned Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time and line management activities of assigned RASs/SASs
  • Ensure accurate compilation, management and tracking of site activation activities in a timely manner.
  • Serve as the primary point of accountability and contact for all start-up activities on assigned projects.
  • Work closely with the assigned team members to expedite the Site Qualification and Selection process as appropriate
  • Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team
  • Perform and prepare a risk assessment and mitigation plans relating to departmental deliverables
  • Work in conjunction with the assigned LCRA and GPL to develop a study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date. Liaise with other functional contributors and vendors as needed.
  • Develop, review, maintain SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department
  • Lead/provide input to departmental process improvement initiatives
  • Ability to interpret site activation metrics and drive corrective action when needed to achieve deliverables or milestones
  • May participate in business development activities by contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets, contracting process, ED process, and other country and/or study-specific requirements or activities necessary for Site Activation
  • Report and/or escalate issues to Site Activation & Regulatory Therapeutic Lead as necessary to ensure resolution and minimize risks to on-time deliverables
  • Remain currently knowledgeable of changing regulatory legislative requirements of the regulatory intelligence database
  • Comply with SOPs, ICH GCP and national regulations as applicable
  • Review and make recommendations on all relevant study regulatory documentation e.g. labels, patient information sheets, diary cards, etc. to ensure compliance with ICH GCP & country-specific requirements
  • Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
  • Contribute towards the preparation of technical /master study documentation in accordance with the study
  • May lead or support post-award Feasibility/Site ID activities
  • Liaise with other functional contributors and vendors as needed

 

OTHER SKILLS AND ABILITIES:

  • Strong oral and written communication skills to clearly and concisely present information
  • Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint, regulatory portals and all Worldwide applications
  • Thorough understanding of clinical research principles and process
  • Thorough knowledge of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
  • Ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to work in an organized, methodical and self-motivated manner
  • Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
  • Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problems


OTHER SKILLS AND ABILITIES:

  • Leadership and interpersonal skills
  • Ability to motivate, lead and engage a team
  • Good oral and written communication skills
  • Planning and organizational skills with effective time management
  • Demonstrated ability to collaborate across the business
  • Ability to work in an organized and self-motivated manner
  • Understanding of startup and clinical research principles and general processes
  • Understanding of regulatory processes, guidelines, and local regulatory requirements
  • Ability to provide experience and input into initiatives relating to interacting with sites and/or customers
  • Understanding of initiation, planning, and execution of clinical projects and overall project planning
  • Ability to proactively identify and solve problems
  • Strong understanding of standard operating procedures
  • Proficient knowledge of Microsoft Office and other contemporary software applications

REQUIREMENTS:

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
  • Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
  • Minimum of 3 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience
  • Proficient in cross-cultural communication
  • Proficient in both spoken and written English

      #LI-HD1      

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Site Activation & Regulatory Affairs Lead (US/Remote)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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