Site Activation Partner I

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 60.000 - 80.000; Tempo integral

Resumo da oferta

A leading company in the biopharmaceutical sector is seeking a Study Start Up Associate to enhance patient lives by accelerating drug and device development. This role involves working closely with clients, performing investigator recruitment, and ensuring compliance with local regulations. The ideal candidate will have a solid understanding of drug research regulations and experience in clinical trials, making them a vital part of the team focused on innovative treatments.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

• Experienced with CEP and CONEP submissions.
• Knowledgeable about local drug research and development regulations.

Responsabilidades

• Perform investigator recruitment activities using various tools.
• Use the Clinical Trial Management System to track activities.
• Collect and maintain essential documents for regulatory compliance.

Conhecimentos

Knowledge of local drug research regulations

Clinical trials support experience

Proficient in English

Descrição da oferta de emprego

Overview

As a Study Start Up Associate, you will play a key role in improving the lives of patients by accelerating the development of our clients' drugs and devices through innovative solutions.

You will be a dedicated resource to one of our clients, embedded in their working environment, systems, and processes. Your tasks will include writing ADaM specifications, programming ADaM datasets, programming efficacy outputs, and submission work.

You will partner with a leading biopharmaceutical company, working across a diverse portfolio of medicines and vaccines, with a history of delivering innovative treatments and preventive medicines globally.

Responsibilities

What you will be doing:

1. Perform investigator recruitment activities using phone scripts, questionnaires, study site materials, and other tools to evaluate investigative sites.
2. Use the Clinical Trial Management System (CTMS) to accurately track investigator recruitment activities.
3. Collect, review, maintain, and close out essential documents, ensuring sponsor and investigator obligations meet local regulatory requirements and ICH/GCP guidelines.
4. Support investigators and staff in fulfilling obligations related to local submissions according to regulatory and IRB/IEC requirements.
5. Track study progress via CTMS or designated systems to ensure files are current, accurate, and complete.
6. Document site and sponsor interactions promptly and professionally.
7. Assist in resolving investigational site/data queries.
8. Review the informed consent template for quality.
9. Follow up on trial invoices and update CTMS for timely investigator payments.

Qualifications

You are:

• Knowledgeable about local drug research and development regulations.
• Experienced with CEP and CONEP submissions.
• Having support experience in clinical trials or the pharmaceutical industry.
• Proficient in English.

What ICON can offer you

Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Besides a competitive salary, ICON offers various benefits focused on well-being and work-life balance for you and your family.

Learn more about working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are core to our culture. We are committed to providing an inclusive and accessible environment for all candidates and a workplace free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need reasonable accommodations during the application process or to perform the job, please inform us through the provided form: https://careers.iconplc.com/reasonable-accommodations

If you're interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we're looking for at ICON, whether for this or other roles.