Key Facts

Remote From:

Brazil , Argentina , Mexico

Full time

Mid-level (2-5 years)

English

Hard Skills

Clinical Monitoring Data Integrity Data Quality Protocol Implementation Conformance Statement Patient Safety

Other Skills

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Communication
•
Teamwork
•
Problem Solving
•
Empathy

Roles & Responsibilities

Minimum of 1 year as a clinical monitor for CRA II
Minimum of 3 years as a clinical monitor for SR CRA
Minimum of 5 years as a clinical monitor for SR CRA II
Educated to degree level in biological science, pharmacy, or other health-related discipline preferred

Requirements:

Ensure data integrity, data quality, and compliance with ICH GCP and local requirements at the site level
Collaborate with the Site Manager for site compliance and inspection readiness
Manage site monitoring and close-out of assigned clinical trials to ensure patient safety
Resolve all protocol-related issues for assigned investigator sites

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel’s Functional Service Provider (FSP) is looking for CRAs II, SR CRAs I and II to join our team in Argentina, Brazil or Mexico.

The Clinical Research Associate II will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements. The Clinical Research Associate II will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.

The Senior Clinical Research Associate I (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and client standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.

Knowledge and Experience:

For the Clinical Research Associate a mininum of 1 year as a clinical monitor with demonstrated experience of monitoring (virtual & onsite).
For the Senior Clinical Research Associate a mininum of 3 years as a clinical monitor with demonstrated experience of monitoring (virtual & onsite).
For the Senior Clinical Research Associate ii a mininum of 5 years as a clinical monitor with demonstrated experience of monitoring (virtual & onsite).

Education:

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Proficiency in local language preferred. English is required