Clinical Study Administrator

Clinical Study Administrator

Location: Leeds

Working mode: Hybrid, 2 days on-site and 3 WFH

Duration: 12 months (opportunity for a contract extension)

Hours: 37 hours per week

Pay rate range: Competitive hourly rate (PAYE and Umbrella options available)

Imagine your next project as Clinical Study Administrator at J&J. CSA is responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required. Supports project managers within the assigned clinical studies.

roles and responsibilities

• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, etc.

• Work with Study Teams and partners to maintain and track relevant activities in CTMS.

• Creation/distribution of regulatory binders

• Timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.

• Distribution of safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).

• Creation and generation of system reports.

• Provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs

• Assist with Device tracking and ordering if required and if applicable.

Metrics/KPIs:

• Metrics/KPIs governing these services are outlined in the QOP document.

Interfaces – Primary/Other:

• Primary interfaces: Provider Functional Manager, TMF Leader , TMF Specialist, CTL, Study Teams, Site Managers, Transition Agents.

Other Interfaces: clinical sites, if necessary.

how to succeed

• Minimum of a Bachelor’s Degree is required.

• Previous clinical research experience a plus.

• Requires previous administrative support experience or equivalent for at least 1 year.

• Clinical/medical background a plus.

• Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email).

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.