Clinical Research Associate

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Remote Job

Posted 4 months ago
Job details
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.
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 FSP is currently seeking CRA/Site Monitors I/II in any location in Italy. As a Site Monitor, you would focus on monitoring at maintenance phase almost exclusively.
You would be dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases.
Our sponsor has a long history of excellence in research, delivering medicines, vaccines, and other health solutions for some of the most difficult diseases in the world.
Key Accountabilities
  • Ensuring regulatory, ICH-GCP and protocol compliance.
  • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
  • Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations
  • Conducts source document review and verification of appropriate site source documents and medical records
  • Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
  • Manages reporting of protocol deviations and appropriate follow up
  • Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
  • Conducts follow up for escalated adverse event monitoring (AEM) report queries
  • Collaborates with primary Site Manager who will act as the primary liaison with site personnel
The Individual
  • A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring
  • Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
  • Must hold the CRA certification
  • English proficiency is required
  • Ability to manage required travel of on a regular basis
Skills
  • Networking and relationship building skills
  • Ability to communicate effectively and appropriately with internal and external stakeholders
  • Ability to adapt to changing technologies and processes
  • Effectively overcoming barriers encountered during the implementation of new processes and systems
  • Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization
  • Identifies and builds effective relationships with investigator site staff and other stakeholders
  • Must demonstrate good computer skills and be able to embrace new technologies

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Remote Job:

  • Yes

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Parexel
Parexel

Current Openings: 0

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.
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