Study Start Up Associate I

ICON Strategic Solutions; México; Remote; MXN 420,000 - 660,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life assurance

Job summary

ICON Strategic Solutions in Mexico is seeking a Site Start-Up Specialist to deliver regulatory start-up and activation tasks for sponsored clinical studies.

You will prepare regulatory documents, coordinate approvals with stakeholders, maintain submissions records, and support study teams with protocols and informed consent forms, while traveling up to 5% as needed. ICON offers stability, global expertise, and career development within a sponsor-dedicated model.

Qualifications

• Bachelor's degree in life sciences or related field.
• Experience in clinical research or regulatory affairs preferred but not required.
• Strong attention to detail and organizational skills.
• Excellent communication and collaboration with cross-functional teams.
• Willingness to travel approximately 5%.

Responsibilities

• Assist in the preparation and submission of regulatory documents.
• Coordinate approvals for study initiation with stakeholders.
• Maintain records of regulatory submissions and approvals.
• Support study teams in developing protocols and informed consent forms.
• Participate in start-up meetings and provide input on regulatory timelines.

Skills

Regulatory coordination

Site start-up

Clinical research

Communication skills

Education

Bachelor's degree in life sciences

Job description

Home Based - Mexico

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Do

Your role will involve delivering site start-up and activation work to a high standard, working closely with your team and stakeholders.

Key Responsibilities Include

• 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.

Your Profile

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required Qualifications And Experience

• Bachelor's degree in life sciences or a related field.
• Previous experience in clinical research or regulatory affairs preferred, but Nt required.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
• Willingness to travel as required (approximately 5%)

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here