Senior Clinical Research Associate

Location
Salary: £ 95000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 204
Published: about 2 months ago

The Company
My client is a Global CRO who deliver clinical research to over 40 countries and whose clientele ranges from small to mid-size companies within the life science sector. Based in 21 countries they are seeking a Senior Clinical Research Associate to join their dynamic team.

The Role

The Senior Clinical Research Associate (SCRA) is part of Clinical Monitoring within the company’s and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct according to company policies, SOPs and regulatory requirements

About you

Responsibilities

  • Monitor on-site clinical trials in accordance with the company’s and/or client company Standard Operating Procedures, FDA regulations and GCP and ICH guidelines

  • Review CRFs and subject source documentation for validity and accuracy and generate queries to validity sites/clients to resolve problem data

  • Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos and verbal communication with Project Manager or Lead CRA

  • Initiates corrective action to resolve issues as directed by supervisor

  • Contribute to the completion of the application to Ethics Committee/ IRB and prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager

  • Participate in contract handling and negotiation directed by Lead CRA/Project Manager

  • Set up ISF and SMF and distribute to the investigational sites

  • In cooperation with the study team, responsible for SMF maintenance

  • Order, ship and reconcile clinical investigative supplies for study sites if applicable

  • May prepare and submit status reports as directed by Lead CRA/PM

  • Review and support site staff to maintain SMF

  • Review Informed Consent documents for essential elements and protocol specifics

  • Update CTMS system with site and study information

  • May audit data in tables and text of clinical summaries

  • May assist in the preparation of study documentation such as CRF completion guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness

  • Prepare check requisitions for sponsor Project Management approval when applicable

Requirements:

  • Bachelor's degree preferably in life science or nursing or equivalent experience

  • 3-5 years of experience as a CRA including relevant experience in Dermatology therapeutic area

  • Able to work in a fast paced environment with changing priorities

  • Ability to work independently as well as in a team matrix organization

  • Excellent verbal and communication skills

  • Excellent organizational skills

  • Ability and willingness to travel 60-70%

Connect

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.

Medella Life

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything