Clinical Trial Assistant, HYBRID in Wilmington, DE

IQVIA; Wilmington (DE); On-site; USD 36,000 - 123,000; Full time

Job summary

IQVIA is seeking an Administrative Support professional to assist Clinical Research Associates and the RSU team in maintaining the Trial Master File and related systems. Your work will help ensure site compliance and timely project delivery by accurately updating documents and coordinating with the clinical team.

You will handle preparation, distribution, filing, and archiving of essential clinical documentation, support review of study files for completeness, and act as a central contact for

Qualifications

• Bachelor's degree or equivalent combination of education, training and experience.
• 3 years administrative support experience.
• Working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills with good command of English.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements (GCP and ICH) and protocol knowledge.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF and related systems to track site compliance and timelines.
• Assist with preparation, handling, distribution, filing and archiving of clinical documentation and reports.
• Assist with periodic review of study files for completeness.
• Assist with handling Clinical Trial Supplies and maintenance of tracking information.
• Track and manage Case Report Forms (CRFs), queries and data flow.
• Act as a central contact for project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring duties after training.

Skills

English communication

Time management

Organizational skills

Interpersonal skills

Regulatory awareness

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

• Bachelor's Degree Required
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $35,800.00 - $123,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.