Lead Clinical Research Specialist

2 weeks ago

Redwood City, California, United States Rezolute, Inc. Full time

Position Overview

The Senior Clinical Research Associate will collaborate closely with the Clinical Operations team to facilitate comprehensive study activities, encompassing site initiation, patient engagement, study oversight, and management of sites and vendors. This role requires cross-functional collaboration within the Rezolute, Inc. team as well as with clinical sites, Contract Research Organizations (CROs), and other service providers.

Key Responsibilities Include:

  • Prepare and maintain regulatory documentation, including study manuals and monitoring plans.
  • Ensure local insurance coverage is secured for each participating region.
  • Coordinate with CROs to guarantee necessary import/export licenses are obtained for the study.
  • Participate in or oversee qualification visits, site initiation, monitoring, and close-out visits.
  • Foster productive and collaborative relationships with cross-functional teams.
  • Manage the identification, follow-up, and resolution of issues at the site, vendor, or study level.
  • Review and oversee the electronic Trial Master File, ensuring vendor participation as necessary.
  • Contribute to clinical project team meetings, providing agendas and minutes as required.
  • Develop and maintain study trackers, including clinical supply inventory management.
  • Safeguard patient welfare by reviewing trial performance at designated sites, ensuring compliance with protocols.
  • Formulate patient recruitment strategies in collaboration with clinical sites to meet enrollment goals while adhering to standard operating procedures (SOPs), protocols, and regulatory requirements.
  • Assess the quality and integrity of reported data, site efficacy, and drug accountability.
  • Monitor the completeness and quality of regulatory documentation, performing site document verification as necessary.
  • Escalate issues to appropriate team members as required.

Qualifications and Requirements:

  • Bachelor's degree in a relevant scientific field or equivalent experience.
  • A minimum of 4 years of relevant experience in clinical research.
  • Familiarity with Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines is preferred.
  • Experience in site management or equivalent clinical research roles, with a solid understanding of clinical trial methodologies and terminology.
  • Ability to independently perform all clinical monitoring activities with minimal supervision.
  • A client-focused mindset and adaptability to new assignments and learning opportunities.
  • Strong organizational skills, capable of managing multiple tasks and adapting to shifting priorities while meeting project timelines.
  • Proficient in electronic clinical databases, Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office Suite.
  • Exceptional verbal and written communication skills.
  • A collaborative team player.
  • Willingness to travel as required.

Preferred Experience and Skills: We seek a highly motivated candidate who can adapt to evolving programs, is available to work in the office at least two days a week, quickly learns new tasks, and contributes effectively to the ongoing needs of the clinical operations team.

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