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Study Start Up Associate I/Study Start Up Associate II

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ICON plc

3mo ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Research & Development
    Healthcare
  • Chennai
  • Quick Apply

AI generated summary

  • You need 2-6 years in clinical research with Essential Document review, knowledge of ICH GCP, and experience with EC, IRB, and CA queries across different countries.
  • You will prepare regulatory submissions, coordinate approvals, maintain records, support study teams, review contracts, mentor staff, and facilitate sponsor-site indemnification processes.

Requirements

  • Knowledge of ICH GCP and Prior clinical research experience with a minimum of 2-6 years’ experience in Essential Document review (Study Start Up)
  • Experience working with different countries
  • Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.

Responsibilities

  • Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
  • Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
  • Maintaining accurate and up-to-date records of regulatory submissions and approvals.
  • Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
  • Participating in study start-up meetings and providing input on regulatory requirements and timelines.
  • To review and negotiate clinical site investigator contracts and budgets.
  • Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents.
  • Prepare and coordinate preparation of contractual documents and correspondence.
  • Facilitate the indemnification process between the study sponsor and the site.
  • Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).

FAQs

What are the primary responsibilities of a Study Start Up Associate?

The primary responsibilities include assisting in the preparation and submission of regulatory documents, coordinating with stakeholders for study initiation approvals, maintaining accurate records of regulatory submissions, supporting study teams in document development, and facilitating contracts and budgets.

What qualifications are required for this position?

A minimum of 2-6 years of clinical research experience, including knowledge of ICH GCP and experience in Essential Document review in Study Start Up is required.

What type of benefits does ICON offer?

ICON offers various benefits including annual leave entitlements, health insurance offerings, retirement planning options, a global Employee Assistance Programme, life assurance, and flexible country-specific benefits.

Is previous experience working with different countries an advantage?

Yes, having experience working with different countries is considered an added advantage for this role.

What is the importance of regulatory submissions in this role?

Regulatory submissions are crucial as they ensure that clinical trials comply with legal and ethical standards, allowing studies to begin and helping to protect the welfare of participants.

Are there opportunities for training and mentorship in this position?

Yes, this role includes opportunities to mentor and train new and junior personnel in the Study Start Up department.

How does ICON promote a diverse and inclusive work environment?

ICON is committed to diversity, inclusion, and belonging, fostering a culture that encourages diverse perspectives and provides equal opportunities irrespective of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Can I apply for this position if I do not meet all the requirements?

Yes, applicants are encouraged to apply even if they do not meet all the requirements, as there is a chance they might be the right fit for the role.

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ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.