Clinical Trial Site Activation Specialist

hace 4 días

Medellín, Antioquia, Colombia Parexel A tiempo completo
About the Role

Parexel is seeking a highly skilled Clinical Trial Site Activation Specialist to join our team. In this role, you will be responsible for leading or supporting operational activities from start-up to close-out for assigned studies and investigator sites.

Job Description

The Clinical Trial Site Activation Specialist is responsible for ensuring compliance with study timelines and prevailing laws, Good Clinical Practices, and client standards. This includes coordinating activities and essential documents management during start-up, preparing and validating regulatory documents, managing and coordinating with other supporting roles, and communicating effectively with study teams and investigator sites.

Key Responsibilities:
  • Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation;
  • Provide support to resolve issues or concerns and timely escalation of site issues where applicable;
  • Prepare, validate, and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines;
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities;
  • Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements;
  • Coordinate the timely communication, documentation, and responses between client and central ethics committee to bring clinical study to approval (country dependent);
  • Support investigators sites with local IRB workflow from preparation, submission through approval;
  • Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures;
  • Support and implement activities in Shared Investigator Platform (SIP) to align with the sponsor strategy as it relates to the role;
Requirements:
  • Bachelor of Science or Bachelor of Arts or equivalent;
  • Minimum 2 years relevant experience in clinical site management;
  • Knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details;
  • Compliance with all applicable company, regulatory, and country requirements;
  • Attention to detail evident in a disciplined approach;
  • Ability to work independently and also as a team member;
  • Ability to organize tasks, time, and priorities, ability to multi-task;
  • Understand basic medical terminology, GCP requirements, and proficient in computer operations;
  • Able to use and learn systems, and to use independently Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File, Electronic Investigator Site File, Document exchange portals, Shared Investigator Platform, Ethics, National Networks, and Governing Bodies Portals and platforms;
  • Flexible and adapt to off-working hours in a global environment (when applicable);
  • Able to travel as needed, including some international travel possible;
  • Fluent in English; multilingual capability is preferred;
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization;
About Parexel

Parexel is a leading global biopharmaceutical services company that provides drug development and commercialization solutions for clients around the world.

Salary Range:

$80,000 - $120,000 per annum, depending on location and experience.

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