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 Site Management 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.

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.

What you will do

• Responsible for interviewing and selecting CRA/IHCRA candidates and ensuring consistent onboarding of permanent and contract CRAs/IHCRAs
• Ensure CRAs are properly and timely trained to perform all types of visits as well as other billable monitoring activities
• Provide on-site mentoring for CRAs through observation or site assessment visits
• Establish regular communication and1:1 calls with CRAs/IHCRAs to review and discuss quality metrics (SVR compliance, SDV metrics, TMF readiness, expense report submissions, project status, etc.)
• Act as point of escalation for CRA/IHCRA performance issues on projects
• Review Time Cards, including review and approval of hours billed by contractors
• Review the accuracy of Sciforma assignments and workload
• Conduct performance appraisals, rewarding and disciplining employees, addressing employee relations issues and resolving problems
• Write and conduct CAPAs when necessary; Support Directors of Clinical Operations
• Approve CRA/IHCRA PTO requests
• Review and approve CRAs/IHCRAs' non-billable expenses

What you will bring to the role

• Ability to understand multiple study protocols.
• Superior oral and written communication skills.
• Strong planning and organizational skills.
• Good interpersonal skills.
• Experienced problem solving/decision making skills.
• Good attention to detail.
• Understanding of clinical research principles and process, data collection and editing skills.
• Ability to navigate in EDC software (InForm, Medidata, etc.)
• Strong knowledge of FDA regulations, ICH Guidelines and HIPAA.
• Understanding of standard operating procedures.
• Knowledge of therapeutic areas.
• Knowledge of Word, Excel and Outlook

Your Background

• Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate OR
• Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
• Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a pharmaceutical or biotechnology company
• Travel required/Valid passport 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 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