Clinical Research Associate II (US West) - 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 Research Associate II (US West) - FSP

Primary Location: United States, Remote Job ID R0000047087 Category Clinical Trials

Apply Now

About This Role

Job Overview

The Clinical Research Associate acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for the allocated sites.

Key Accountabilities

Site Management Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
• Gains an in-depth understanding of the study protocol and related procedures
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
• Participates and provides inputs on site selection and validation activities
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased
• Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager
• Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines

Team Development and Support

• Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
• Supports and/or leads audits/inspection activities as needed
• Performs co-monitoring visits where appropriate

Compliance with Parexel Standards

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

Skills

• Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices
• Proven skills in Site Management including management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgement
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Ability to understand and analyze data/metrics and act appropriately
• Capable of managing complex issues, working solution-oriented manner
• Performs root cause analysis and implements preventative and corrective action
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• Demonstrated high level of monitoring skill with independent professional judgement
• Able to work highly independently across multiple protocols, sites, and therapy areas
• 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
• Works with high quality and compliance mindset
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices

Knowledge And Experience

• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO

Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs.

Education

• Bachelor’s degree preferred with a strong emphasis in science and /or biology

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 iCRA Twins Marina Palumbo and Anna Korelis

Double the passion and double the commitment to working With Heart™. Read on to learn more about these colleagues whose family and work lives are uniquely intertwined at Parexel!

Learn more

• Meet Laurias: Manager, Clinical Operations

Laurias shares how Parexel has supported his career development from CRA to Clin Ops Manager and flexibility within the workplace.

Learn more

• Working as a Nurse in Clinical Research at Parexel

Antje and Katharina share insights into working as a Nurse in Clinical Research, where innovative medications are developed through early-phase and first-in-human studies.

Learn more

• Meet Adriane, a Senior Clinical Operations Leader sharing insights and tips

Discover Adriane's role as a Clinical Operations Leader. She shares insights into her daily responsibilities, the skills crucial for success, and the rewarding challenges she faces. Learn how Parexel supported her career development and gain inspiration from her advice on professional growth.

Learn more

• Meet Julie, a Senior Clinical Assistant, proud of her contribution

Julie welcomes volunteers at the Early Phase Clinic reception in Berlin, manages payments, and caters to the volunteers in the kitchen.

Learn more

• Video on Working With Heart® - Christina's Clinical Operations Manager Perspective

View how Christina reflects on her work experience, her impact on patients and her management style of respect and growth. Christina is leading a team of Clinical Operations Leaders who manage groundbreaking trials in the biotech space.

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 Stacy Hurt, Chief Patient Officer at Parexel

Insights on Parexel's patient-centric approach, innovative strategies, and authentic culture in clinical research. Learn how Stacy's unique experiences shape the future of clinical trials.

Learn more

• Meet Hina, an Executive Director championing excellence and empathy

Parexel's Hina Saleem, Executive Director, Clinical Operations, shares how empathy and excellence drive her approach to clinical trial optimization and authentic leadership.

Learn more

• Meet Margaret: Clinical Research Nurse

Find out why Margaret enjoys working as a Nurse in Clinical Research and working at Parexel, also how Parexel supports her in a way she hasn't experienced anywhere else.

Learn more

• Meet David, a champion for disability inclusion

His leadership fosters workplace and clinical research inclusivity. Explore David's inspiring journey from combat medic to Parexel VP and Disability Inclusion Business Resource Group co-lead.

Learn more

• Meet Andrea: Senior Initiation Clinical Research Associate

Andrea's story shows how teamwork, attention to detail and patient focus drive success at Parexel while finding fulfillment in helping innovative treatments reach patients faster.

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

• 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

• 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

• 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

• New Medicines, Novel Insights Newsletter

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

Learn more

JOBS FOR YOU

• Scientist III - Analytical Chemist (Drug Product) - FSP Northeast, United States of America
• Feasibility Study Manager United States of America, Remote
• Clinical Research Associate II (US West) - 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