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
Embark on a fulfilling Clinical Operations career as you leave a lasting impact on patients’ lives. Join Worldwide Clinical Trials for an unparalleled CRO experience, where you can drive extraordinary scientific breakthroughs and contribute to the very heart of every successful clinical trial.
What you will do
Working alongside brilliant minds across a variety of therapeutic areas, you will have the chance to collaborate closely with top-tier colleagues from diverse backgrounds and specialties. Our commitment to advancing clinical research is cultivated in a supportive, team-oriented atmosphere, with our hands-on leadership and dedicated team members working together to innovate and solve complex challenges for our customers.
Responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff within a geographic region. Responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region.
Tasks may include but are not limited to:
Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes
Provide leadership and direction to clinical site management team members from study start through to closure
Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to:
Primary SM Sponsor contact
Investigator and Bid Defense Meeting
Internal and External study team calls
Project specific Audits / Inspections
Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities
Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP)
Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters
Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP.
Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed
Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target
Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality
Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed
Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready
Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed
Review/finalize trip reports according to Worldwide SOPs and expectations
May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed
Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed
Proactively identify and mitigate risks
May represent site management as primary contact on projects
Conduct co-visits where required to ensure quality of site, the CRA work and study procedures.
What you will bring to the role
Excellent interpersonal, oral and written communication skills in English + Portuguese (preferred) .
Excellent planning and organizational skills with effective time management
Excellent presentation skills
Flexibility to change
Ability to manage multiple and varied tasks with enthusiasm
Ability to negotiate and influence with diplomacy in order to achieve results
Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified
Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision
Ability to lead and motivate a team remotely
Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
Strong customer focus, ability to interact professionally within a sponsor contact
Extensive understanding of clinical research principles and process
Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements
Experience in the study therapeutic indication/area
Thorough understanding of standard operating procedures
Proficient knowledge of Microsoft Office, eCRF, IVRS packages
Proficiency with IxRS, CTMS and EDC systems
Your experience
Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR
Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate, or minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities
Travel required
Valid current passport required
Driving license required
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
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 .
