Sponsor Junior Study Startup Associate Hybrid / Remote

Category: Junior Study Startup Associate
Job #: 10910
Utilization: 100%
Location: Arden Hills MN, Marlborough MA, Maple Grove MN, or Valencia CA
Job Type: 1099
Therapeutics: No Specific TA Required

What an incredible opportunity for career growth—working directly with a Sponsor!  Our Sponsor is a recognized leader across multiple therapeutic areas, and they are seeking a proactive Study Startup Associate. In this role, you’ll work independently to coordinate all activities related to site regulatory submissions and essential document collection for assigned clinical research sites in the study startup sector.

This is a full time, 6-month contract Junior Study Startup Associate and our Sponsor needs you to be able to work 3 days per week onsite at one of their four locations, and 2 days per week remote.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
    Manage one or multiple studies.
  • Monitor product supplies/accountability including proper storage, dispensation, and disposal.
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • Must be located driving distance to one of these four locations: Arden Hills MN, Marlborough MA, Maple Grove MN, or Valencia CA and able to work 3 days per week on location and 2 days per week remote
  • Bachelor’s degree, or a comparable mix of education and experience based on years in the field
  • Must have a minimum of 2 years' experience in clinical research
  • Must have at least 1 year of clinical study site start-up experience within the US
  • Must have experience with IRB submissions, ICF customizations & negotiations, and capturing and maintaining essential documents
  • Must have experience working with clinical trial management systems and clinical document control systems / eTM
  • 100% utilization required (40 hours a week) for a 6-month contract. High probability there will be options for conversion to another contract or perm placement.
  • Competitive Hourly Rate
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