Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Clinical Monitoring Adverse Event Monitoring Cross-Functional Collaboration Infoblox IPAM Virtual Training Performance Management Clinical Data Analysis Training Documentation Regulatory Compliance Site Assessment Internal Documentation Auditing Clinical Trial Management Systems Mentoring Youth Query Planning Remote Administration Negotiation Training Escalation Procedures Meeting Facilitation

Other Skills

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Communication
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Time Management
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Teamwork
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Detail Oriented
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Empathy
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Social Skills
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Problem Solving

Roles & Responsibilities

Experience as a Clinical Research Associate (CRA) II or equivalent
Strong knowledge of ICH GCP guidelines and local regulatory requirements
Experience monitoring clinical trials, site qualification, initiation, and close-out activities
Excellent communication, problem-solving, and mentoring abilities

Requirements:

Implements and monitors clinical trials to ensure sponsor and investigator obligations are met and compliant with applicable local regulatory requirements and ICH GCP
Assesses qualification of investigative sites, initiates trials at sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
Reviews and verifies accuracy of clinical trial data collected (on-site or remotely) and performs source document verification and query resolution
Communicates with investigative sites, provides regular site status updates to the team, escalates trial-related issues per SOPs, supports audits and audit resolution, and mentors junior CRAs

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.

Key Role and Responsibilities Summary:  

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.

Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of 
clinical trials, and close clinical trials at investigative sites.

Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.

Provides regular site status information to team members, trial management, and updates trial management tools,

Completes monitoring activity documents as required by SOPs or other contractual obligations.

Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.

Escalates site and trial related issues per SOPs until identified issues are resolved or closed.

Performs essential document site file reconciliation.

Performs source document verification and query resolution.

Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.

Verifies SAE reporting according to trial specifications and ICH GCP guidelines.

Communicates with investigative sites.

Updates applicable tracking systems.

Ensures all required training is completed and documented

Serves as main observer/assessor of site activities.

Facilitates audits and audit resolution.

To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.