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Study Start-up Specialist I/II

Aplica ya
Mapa de ubicación: Mexico City, Mexico Full time R1257823

Descripción del trabajo


Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up.  Work with both internal and external teams to assure good communication, regarding documentation processing.  Assure documents maintained for a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQIA Biotech and its clients.  A SSUS I may be assigned to one or more start-up projects.  A SSUS I will work in conjunction with or under the supervision of a more senior SSUS and/or Manager Level, SSU. 


  • Supports the lead SSUS or representative to provide updates during weekly client teleconferences and internal team meetings, as required.
  • Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members, and sponsor to enable a rapid clinical trial start-up.
  • May participate in the drafting of the feasibility questionnaire for a study.
  • May assist in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.
  • May participate in the review and negotiation of the CDAs according to country specific requirements.
  • Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process.
  • Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
  • Supports sites to answer any questions required for their local IRB/ethics committee submissions.
  • Serves as IQIA Biotech liaison with CEC/central IRBs/REBs/ECs, as applicable.
  • May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
  • Contacts sites directly, or through local representative (country dependent), as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.
  • May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.
  • Liaise with legal and internal team to secure authorization of site contracts.
  • Coordinate document translations required for CEC/EC submissions, as needed. 
  • Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA), CEC and Ethics Committee (EC) submission documentation, and similar information for other related organizations, for the assigned countries.
  • Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
  • Notifies the Regulatory Advisor representative (RA-R) when initial essential documents are available for review.  Works with RA-R to resolve any concerns.
  • Adheres to study timelines, documents/escalates study challenges, and communicates updates to Project Manager and SSU Lead/Management.
  • Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study. 
  • Responsible for transitioning sites from SSU to File Maintenance representative.
  • Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
  • Participates in financial and/or resource forecasting, as applicable.
  • Performs other duties as required.


  • Knowledge of clinical research process related to study start-up and medical terminology
  • A basic understanding of Regulatory and Central/Local ethic submission processes for assigned countries
  • Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
  • Excellent organizational and interpersonal skills
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
  • Ability to manage multiple competing priorities within various clinical trials
  • Working knowledge of current ICH GCP guidelines and applicable regulations
  • Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor administrative staff
  • Excellent verbal and written communication skills required in local language for assigned countries
  • Ability to work independently, prioritize and work with a matrix team environment is essential
  • Working knowledge of Word and Excel is required 
  • Ability to travel periodically if needed


  • Bachelor’s degree (or equivalent), preferably in science or related field and 6 months – 2 years relevant experience
  • Equivalent combination of education, training and experience

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at

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