Senior Clinical Research Associate - CNS/Psychiatry - Southeast - Remote
Worldwide Clinical Trials · North Carolina, United States
- Hybrid
- Full-time
- $100,000 / year
- North Carolina, United States
Job highlights
- Manage clinical research activities at study sites.
- Oversee all study phases, from initiation to close-out.
- Conduct remote site management and ensure compliance.
- Utilize proficiency in MS Office, CTMS, and EDC systems.
- Requires 5+ years experience and CNS/Psychiatry focus.
About the role
About Worldwide Clinical Trials
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, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are 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 are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote 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!
What Clinical Operations Does At Worldwide
At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the on the lives of patients. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs.
Through regular touchpoints and coaching conversations with your Line Manager, we ensure that your professional development remains a top priority. We offer a clear career path and development that can lead to Clinical Trial Manager roles. We take pride in our accessible Executive Leadership team, who are equally committed to advancing science and surmounting obstacles to make a difference in the lives of patients around the world. We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial. Experience a world of difference with us at Worldwide!
What You Will Do
- Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects.
- Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded.
- Conduct study initiation visits (SIVs).
- While most of the site management efforts will be performed remotely, you will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements.
What You Will Bring To The Role
- Excellent interpersonal, oral, and written communication skills in English.
- Superior organizational skills with attention to detail.
- Ability to work with little or no supervision.
- Proficiency in Microsoft Office, CTMS, and EDC Systems.
Your Experience
- 5+ years of experience as a Clinical Research Associate.
- 4-year university degree OR Nursing Degree.
- Experience in CNS/Neurology is required; Psychiatry is strongly preferred.
- Candidates must reside in the Southeastern United States.
- Willingness to travel regionally required.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and we are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Key skills/competency
- Senior Clinical Research Associate
- CNS/Psychiatry Research
- Clinical Trial Management
- Regulatory Submissions
- TMF Management
- Site Management
- Data Collection
- Safety Reporting
- Informed Consent
- Clinical Operations
Skills & topics
- Clinical Research Associate
- CRA
- CNS
- Psychiatry
- Clinical Trials
- CRO
- Regulatory Submissions
- Site Management
- Data Management
- Healthcare
How to get hired
- Tailor your resume: Highlight your 5+ years of Clinical Research Associate experience, emphasizing CNS/Neurology and Psychiatry focus, along with your 4-year degree or Nursing background.
- Showcase relevant skills: Detail your proficiency in Microsoft Office, CTMS, and EDC systems, and your ability to work independently.
- Emphasize location and travel: Clearly state your residency in the Southeastern United States and your willingness to travel regionally.
- Prepare for behavioral questions: Be ready to discuss how you manage research activities, ensure compliance, and train sites effectively.
- Research Worldwide Clinical Trials: Understand their mission, values, and commitment to patient well-being and scientific advancement.
Technical preparation
Behavioral questions
Frequently asked questions
- What are the primary responsibilities of a Senior Clinical Research Associate at Worldwide Clinical Trials?
- As a Senior Clinical Research Associate at Worldwide Clinical Trials, your primary responsibility will be managing research activities at clinical trial sites. This includes all stages of a study, from site identification and start-up activities like regulatory document collection and contract negotiation, to training sites, monitoring study progress, and managing site close-out procedures. You will also conduct study initiation visits (SIVs) and ensure compliance with informed consent, safety reporting, and regulatory requirements, with a significant portion of site management performed remotely.
- What specific experience is required for the Senior Clinical Research Associate role?
- The role requires a minimum of 5 years of experience as a Clinical Research Associate. A 4-year university degree or a Nursing Degree is also necessary. Crucially, experience in CNS/Neurology is mandatory, and experience in Psychiatry is strongly preferred. Candidates must also reside in the Southeastern United States and be willing to travel regionally.
- Is this a remote position, and what are the location requirements?
- While the Senior Clinical Research Associate role involves remote site management efforts, it is not fully remote in terms of candidate location. Candidates must reside in the Southeastern United States. A willingness to travel regionally is also a requirement for the position.
- What therapeutic areas does Worldwide Clinical Trials focus on, and does this role involve specific ones?
- Worldwide Clinical Trials works across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. This specific Senior Clinical Research Associate role requires a strong background in CNS/Neurology and a preference for Psychiatry experience, aligning with the company's focus in Neuroscience.
- What kind of career development opportunities are available for a CRA at Worldwide Clinical Trials?
- Worldwide Clinical Trials emphasizes professional development for its CRAs. They provide regular touchpoints and coaching conversations with Line Managers to support career growth. There is a clear career path outlined, with opportunities to advance into roles such as Clinical Trial Manager. The accessible Executive Leadership team is also committed to advancing science and supporting employee development.
- What technical skills are needed for this Senior Clinical Research Associate position?