Evergreen Global Trial Associate

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

1 Provide administrative and logistical support to Clinical Trial Assistant (CTAs) SM and/or

LTM 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.

2 Support the local study team in performing site feasibility and/or country feasibility.

Collaborates with the Global Project Team e.g. Clinical Trial Manager (CTM)/Global Trial

Lead (GTL) local management/Country Head and other study team members as required.

3 Maintain information in relevant systems including electronic filing (electronic Trial Master

File: eTMF).

4 Ensure current versions of the required trial documents trial-related materials and supplies

are provided to the investigational site within required timeframes as applicable.

5 Support CTA SM and/or LTM in collecting/preparing documents required for study start-up/

submission to Ethics Committee/IRB and/or Health Authorities.

6 Support CTA SM and/or LTM in collecting processing and archiving study related

documents as appropriate. Use appropriate systems to ensure file completeness at

designated study milestones.

7 May assist team in conducting local investigator meeting or with planning for the investigators

participating in an international meeting.

8 Maintain and update contact information in relevant systems to ensure appropriate safety

updates distribution.

9 Comply with all training requirements company policies & procedures and all applicable laws

and regulations. Always act aligned with J&J Credo.

10 Ensure inspection readiness at all times.

11 May contribute to process improvement.

12 Support SM and within a reasonable timeframe be able to take on responsibility in executing

activities within site initiation and start-up preparation and conduct of site monitoring

(including remote monitoring) site management (by study specific systems and other

reports/dashboards) and site/ study close-out according to Standard Operating Procedures

Work Instructions (WIs) and policies.

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

assigned.

Required Skills:

Preferred Skills: