• Independently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits • Oversee study site performance, including recruitment progress, and provide ongoing support to sites • Review eCRF data, timelines, and queries; identify and report protocol deviations • Maintain clear communication with project management and sponsors • Collaborate cross-functionally with medical, project management, quality management, and data management teams

• Act as the direct contact with assigned sites • Manage site quality and delivery • Build relationships with investigators and site staff • Evaluate site recruitment strategies and propose improvements • Conduct on-site and remote visits to ensure compliance

Title: Senior Clinical Research Associate - Psychiatry - East Coast - Remote remote type Remote locations Research Triangle Park, North Carolina time type Full time job requisition id JR102111 Job Description: 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, 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 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 Psychiatry is required - Candidates must reside in the East Coast United States - Willingness to travel regionally required 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 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.

Role Description We're looking for a full-time CRA to ensure effective, risk-proportionate monitoring of Lindus' global portfolio of clinical trials, with immediate focus on supporting a major trial across 15+ US sites involving over 7,000 patients. Primary emphasis on remote monitoring, though some onsite visits may be required. - Undertake the preparation, conduct, and reporting for all types of monitoring visits, from site selection through to close-out visits. - Conduct central monitoring through our Citrus platform. - Maintain high monitoring standards as our customer base grows significantly. - Work autonomously within a lean team structure, directly interfacing with Trial Managers to help shape monitoring strategy. - Collaborate closely with Clinical Operations, Product, and Commercial teams, as well as sponsor-side teams that make up our customer base. Qualifications - 3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV, COV). - Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches. - Strong working knowledge of GCP/GDP and regulatory requirements. - Great attention to detail and confident communication with internal and external stakeholders. - Autonomous, proactive, organized, and creative with a bias to action. - Comfortable with up to 60% travel during busy periods. - Ideally based in the East Coast Time Zone near a major airport hub. - Full US driving license. - Experience in a startup or early-stage environment is advantageous. Requirements - Develop strategies to effectively support remote monitoring. - Review and develop monitoring plans effectively. - Understand how to take a risk-proportionate approach to monitoring. - Strong awareness of clinical trial regulations and potential changes to the regulatory environment. Benefits - Competitive salary plus meaningful equity. - $2,000 annual Learning & Development budget for courses, certifications, and conferences. - 39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day). - $800 monthly employer contribution for insurance coverage (via Trinet PEO). - $40 monthly wellness allowance with flexibility on spending. - Access to gym and retail discounts through Happl. - Monthly lunch vouchers for remote team members. - Regular company events and team gatherings (both virtual and in-person). - Charity partnerships and volunteering opportunities with Forward Trust. Company Description We're powering biology's century with radically faster, more reliable clinical trials. Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.