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Study Start-up Specialist I/II

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

Descripción del trabajo

BASIC FUNCTIONS:

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. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • 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, SKILLS & ABILITIES:

  • 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

MINIMUM RECRUITMENT STANDARDS:

  • 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 jobs.iqvia.com.

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