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 the Clinical Operations Department does at Worldwide Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience - one you can t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient s life depends on it - because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. What you will do Responsible for managing the research activities at sites participating in Worldwide s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies 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 sites activities during study maintenance, and closing down research activities at the sites once the study has c oncluded Conduct study initiation visits (SIVs) While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirement What you will bring to the role Excellent interpersonal, oral, and written communication skills in English Superior organizational skills with attention to details 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 Demonstrable experience of handling multiple protocols across a range of therapeutic indications Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) Ability to meet the travel requirements of the job 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 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 .

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 The Clinical Operations Department Does At Worldwide Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. What You Will Do Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies 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, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirement What You Will Bring To The Role Excellent interpersonal, oral, and written communication skills in English Superior organizational skills with attention to details 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 Demonstrable experience of handling multiple protocols across a range of therapeutic indications Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) Ability to meet the travel requirements of the job 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 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 . Show more Show less

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 The Regulatory Affairs Department Does At The Worldwide Regulatory Affairs plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process What You Will Do Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff What You Will Bring To The Role Clearly, proven leadership and organizational management skills are essential attributes Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills Excellent written and verbal communication skills to clearly and concisely present information Relationship-building competency combined with demonstrated comfort supporting Business Development at a face-to-face meeting Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment Your Experience A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR… Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years experience within clinical research (e.g. CRA, Reg Affairs.) Minimum 5 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience Proficient in cross-cultural communication and proficient in both spoken and written English 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 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 .