Clinical Trial Assistant

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Clinical Trial Assistant to be located in Spring House, PA.

Purpose:

The Clinical Trial Assistant supports the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. Ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTAs.

You will be responsible for:

• Provide administrative and logistical support to LTM and/or SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.

• Supports the local study team in performing site feasibility and/or country feasibility.

• Maintains information in relevant systems.

• Drive study start-up activities to accelerate site open timelines.

• Review and ensure the accuracy of regulatory documents, including Informed Consent Forms (ICFs).

• Ensures current versions of the required trial documents, trial related materials and supplies are provided to the investigational site within required timeframes, as applicable.

• Support LTM and/or SM in collecting/preparing documents required for study startup/ submission to IEC/IRB and/or HA.

• Support LTM and/or SM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.

• May assist LTM in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.

• Maintains and updates contact information in relevant systems to ensure appropriate safety updates distribution.

• Comply with all training requirements.

• Ensure inspection readiness at all times.

• May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.

• May be assigned as a coach and mentor to a less experienced CTA.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications / Requirements:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field is required.

• Skills set corresponding with 2+ years relevant clinical trial experience is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

• Proficient in English language.

• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).

• Strong interpersonal and negotiating skills preferred. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environm