Senior Clinical Research Associate - CNS - West Region

worldwide.com; North Carolina; Remote; USD 80,000 - 110,000; Full time

Job summary

A leading global Clinical Research Organization seeks a Senior Clinical Research Associate in North Carolina. This role involves site management, monitoring, and ensuring compliance with clinical research standards. Candidates should have relevant degrees and substantial experience, making a significant impact on patient care.

Qualifications

• 3+ years as a CRA with MD/Pharmacist or 5+ years with relevant science degree.
• 7+ years CRA experience with nursing/life science degree.
• Willing to travel and fluent in local languages and English.

Responsibilities

• Perform site qualification and monitoring visits.
• Lead CRAs and mentor junior staff.
• Manage regulatory and ethical documentation.

Skills

Excellent communication

Planning

Organizational

Interpersonal

Problem-solving

Leadership

Education

Medical Doctor (MD)

Pharmacist degree

Relevant science degree

Nursing/life science degree

Tools

Microsoft Office

IxRS

EDC systems

Job description

Senior Clinical Research Associate - CNS - West Region

Apply remote type: Remote | Locations: Research Triangle Park, North Carolina | Time type: Full time | Posted on: Yesterday | Job requisition id: JR101018

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, a global team of over 3,500+ experts, bright thinkers, dreamers, and doers, changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives, and we seek others who share this pursuit.

Why Worldwide

We believe everyone plays an important role in making a difference for patients and their caregivers. From our accessible leaders to our supportive teams, we are committed to enabling professionals from all backgrounds to succeed. We prioritize diversity and inclusion to foster collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Summary: Responsible for site qualification, initiation, interim monitoring, site management, and study close-out visits in accordance with GCPs and applicable regulations. Ensure quality and timely submission of data, including safety reporting.

Responsibilities:

1. Perform feasibility studies for potential sites.
2. Conduct pre-study, initiation, and interim monitoring visits following protocol requirements.
3. Function as Lead CRA for global studies, coordinating CRAs.
4. Develop Clinical Monitoring Plans as requested.
5. Review site visit reports and provide feedback.
6. Mentor less experienced CRAs and site staff.
7. Design study tools and templates.
8. Participate in study team and investigator meetings.
9. Assist in bid defenses and training sessions.
10. Collaborate with Project Management on study milestones.
11. Manage regulatory and ethical documentation.
12. Coordinate study material shipments.
13. Document visit findings and provide updates for site documentation.
14. Ensure site compliance with IP receipt and accountability.
15. Conduct site visits for assessment or training.
16. Complete final site close-out visits and reports.
17. Perform other duties as assigned.

Skills and Abilities: Excellent communication, planning, organizational, interpersonal, and problem-solving skills. Ability to lead and motivate teams. Extensive understanding of clinical research principles, FDA/EU regulations, ICH guidelines, and SOPs. Proficiency in Microsoft Office, IxRS, and EDC systems.

Requirements: Medical Doctor (MD) or Pharmacist degree with 3+ years as a CRA, or relevant science degree with 5+ years as a CRA, or nursing/life science degree with 7+ years CRA experience. Willing to travel, valid passport, driving license, fluent in local languages and English.

We love knowing that our work improves lives. For other roles, visit our careers page at Discover a world of difference at Worldwide. For more info, visit www.Worldwide.com or LinkedIn.

Worldwide is an equal opportunity employer committed to diversity and inclusion. We provide equal employment opportunities regardless of race, gender, age, disability, or other protected classes.

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