Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Good Clinical Practices (GCP) Clinical Research Coordination Website Monitoring Electronic Trial Master File Taking Meeting Minutes Digital File Management Standard Operating Procedure Developing Training Materials Veeva Vendor Management +8 more

Other Skills

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Microsoft Excel
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Microsoft PowerPoint
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Microsoft Word
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Teamwork
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Non-Verbal Communication

Roles & Responsibilities

MS/MA/PhD or BA/BS (or nursing degree) is essential.
At least 3 years of experience in clinical studies; 4 years preferred, pharma industry experience preferred.
Previous site monitoring or study coordinator experience.
GCP regulations and SOPs knowledge, with familiarity with TMF/CTMS systems (e.g., Veeva Vault, Smartsheet, SharePoint).

Requirements:

Support Phase 1–4 clinical studies with guidance, ensuring activities comply with GCP and SOPs.
Manage study/site essential document review, collection, tracking, and TMF oversight from study start-up through maintenance and close-out.
Organize study-related meetings, prepare agendas/minutes, and maintain risk/issue/decision logs; may lead meetings.
May perform site monitoring/co-monitoring visits (ad hoc, pre-study, initiation, routine, close-out) and assist with vendor oversight as guided.

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 are currently recruiting for an experienced Global Clinical Trial Coordinator, to join one of our fastest growing oncology sponsors in Europe as a Clinical Trial Specialist.

In this role you will be accountable for supporting moderately complex clinical study activities in support of the Clinical Trial Manager. Whilst working closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. You may assist with vendor oversight and management with guidance, by helping to identify issues in a timely manner and escalate to management as appropriate.

You may complete monitoring visit report review and perform co-monitoring or monitoring oversight visits

This will be a fully remote home-based position.

Some specifics about this advertised role

Support Phase 1, 2, 3 and 4 clinical studies with guidance.
Support activities related to study/site feasibility, start-up, maintenance, and close-out.
Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out.
With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable (including but not limited Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.)
Study Trial Master File (TMF) oversight.
- Ensure required study documents received, reviewed, and filed in the TMF in accordance with SOPs, GCP and applicable regulations.
Organize study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs.
May lead and present at study related meetings.
May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
At least 3 years of experience (4yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred).
Previous site monitoring or study coordinator experience is preferred.
Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
Understanding of study phases and general knowledge of how they apply to clinical development.
Demonstrated ability to work independently and in a team environment.
Advanced knowledge of Word, Excel, and PowerPoint.
Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
Knowledge of the principles and practices of computer applications in database management.
Strong verbal and written communication skills required.
10% - 20% travel may be required.

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