Clinical Trial Coordinator - FSP

My research opens up new medical possibilities.

And I do it

Search Jobs

Search Jobs

Keyword

Matching job links will appear below as you type.

Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures.

Radius: Enter distance 5 15 25 35 50

Unit MILES KM

View Remote Jobs View All Jobs

View remote jobs View all jobs

Clinical Trial Coordinator - FSP

Primary Location: United States, Remote Job ID R0000047461 Category Project Leadership

Apply Now

About This Role

Parexel FSP is seeking Clinical Trial Coordinators to join our team in US! Candidates should 1-2 years of experience in clinical research.

Job Summary

The Clinical Trial Coordinator supports the Clinical Research Manager and other team members through the life cycle of the study from study start up to study closure.

Key Accountabilities

Trial and site administration:

• Tracking (e.g., essential documents) and reporting (e.g., Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request

Document Management

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Assist with electronic Trial Master File reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions
• Document proper destruction of clinical supplies
• Prepare Investigator trial file binders
• Execute electronic Trial Master File Quality Control Plan
• Obtain translations of documents

Regulatory & Site Start Up Responsibilities

• Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely manner
• Obtain, track and update study insurance certificates
• Support preparation of submission package for Institutional Review Board / Ethics Review Committee and support regulatory agencies submissions
• Publish study results for Global Clinical Trial Operations and Regulatory Affairs where required per local legislation

Budgeting, Agreement And Payments

• Development of country and site budgets (including Split site budget)
• Tracking and reporting of negotiations
• Maintenance of tracking tools
• Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements)
• Updating and maintenance of contract templates (in cooperation with Legal Department)
• Payment calculation and execution (investigators, vendors, grants)
• Ensuring compliance with financial procedures
• Monitoring and tracking adherence and disclosures
• Budget closeout
• Obtain and process Foreign Corrupt Practices Act documentation in a timely manner

Meeting Planning

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support where applicable)

Compliance With Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately and timely as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required
• International Council for Harmonization ‐ Good Clinical Practice knowledge appropriate to role
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g., sites and investigators)
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus
• Able to work independently
• Proactive attitude to solving problems / proposing solutions
• Positive mindset, growth mindset, capable of working independently with assigned tasks
• Contributes to Clinical Trial Coordinator team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required

Knowledge And Experience

• Minimum 1-2 years in Clinical Research or relevant healthcare experience Note - Specific experience requirements may vary depending on the Country.

Education

• Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Apply Now

Share this Page

• X (opens in new window)
• Facebook (opens in new window)
• LinkedIn (opens in new window)
• Email (opens in new window)
• Meet Iram Qayum, An Associate Project Director

With 18 years in clinical research, Iram Qayum, Associate Project Director at Parexel, leads clinical trials with a focus on operational excellence and patient care. Discover her journey of leadership, growth, and making an impact in the healthcare industry.

Learn more

• A day in a life of a Project Leader

Christine and Ewa share what a Project Leader does, why to become a Project Leader, and what mindset is needed. Explore how a Project Leader resembles a cheerleader or a coxswain of a rowing boat!

Learn more

• Project Leadership Opportunities

Learn how Project Leaders partner with pharmaceutical and biotech clients, manage with determination and With Heart, and our unwavering commitment to patient-centricity.

Learn more

• Mika Pollack: Insights into Project Leadership at Parexel

Mika Pollack, a Project Director at Parexel, shares her journey from autism research to clinical trials, and how she embodies Parexel's focus on being a trusted partner to sponsors through building relationships, delivering insights, and finding innovative solutions.

Learn more

• Optimizing the clinical research workforce: An industry analysis by Parexel

This comprehensive report benchmarks the trends and innovations having the greatest impact on drug development and identifies the skills required for today’s workforce.

Learn more

• Meet Donata, a Senior Project Leader focusing on quality and growth

Donata's advancement from an entry-level position to Senior Project Leader at Parexel showcases her dedication to quality and determination to exceed client expectations. Her journey reflects the supportive and growth-oriented environment at Parexel, where passion and hard work pave the way for making a meaningful impact.

Learn more

• Our work culture

Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth.

Learn more

• Working where it works for you

Parexel offers a flexible approach to work that meets your personal needs while maintaining quality delivery for patients. Choose the right work arrangement for you - in-office, home-based or a mix.

Learn more

• Inclusion at Parexel

Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

Learn more

• Benefits & Support

At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

Learn more

• New Medicines, Novel Insights Newsletter

Parexel's insight-generation engine, our people, share perspectives on patient-guided clinical research.

Learn more

• Parexel’s hiring process

It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.

Learn more

JOBS FOR YOU

• Site Contracts Associate II Petaling Jaya, Malaysia
• Regulatory Publishing Consultant (Regulatory Systems SME) Canada, Remote
• Clinical Trial Coordinator - FSP United States of America, Remote

View All Jobs

There is no jobs to view

You currently have no saved jobs to view.

Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page..

View Open Positions

More Than A Job

Benefits

Benefits vary by country, but Parexel is passionate about our team’s overall wellness.

Learn More

Career Advancement

We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career.

Learn More