Senior Clinical Research Associate

About the position

As a Senior Clinical Research Associate in US you are expected to function independently on advanced level in all aspects of monitoring of the trial. Some of the tasks to solve:

• Conduct feasibility (qualification) visits, Site Initiation Visits, Monitoring Visits and Close Out visits at assigned clinical sites and generate visit reports.
• Ensure the quality of the study while on site, through Source Data Verification, Source Data Review, drug accountability and Investigator Study Files review.
• Protect patients by ensuring the rights and well-being of the study subjects are maintained.
• Build relationship with Investigators and Study Coordinators at clinical sites to facilitate a well-functioning collaboration.
• Full ownership of sites assigned and attention to other US sites when relevant.
• Develop patient recruitment strategies together with the clinical sites to meet enrollment timelines, while also ensuring compliance with SOPs, Study Protocols, GCP and the applicable regulatory requirements.
• May be involved in planning aspects of the trials such as protocol design and generation of study forms.
• Being an integrated voice in the US sponsor/CRO/Site ecosystem.

Work location

Remote/home based

Travel

The role requires travel up to 75%.

Advantages of working with NBCD

• You will play an important role in a dynamic research-organization with global reach.
• You will work in an environment driven by science and good ideas, where you can truly make a difference and see your own ideas come to life.
• We offer you the possibility of broadening your skillset, being introduced to all aspects of our operating model.
• As a Senior CRA with NBCD you will have multiple opportunities to develop professionally within clinical research.
• Being a global company, NBCD will also provide a network of international colleagues you will be able to interact and collaborate with.
• We invest in developing our staff and take pride in being a flat, tight organization in which your contribution matters.
• For our permanent employees, NBCD offers a competitive package in terms of base and incentive compensation.

About you

Desired skills and experience:

• Bachelor’s degree in biology, pharmacy, nursing or other health care related discipline.
• + 5 years of experience working as a CRA (or similar role) with involvement from all monitoring and site management activities of the trial such as Site Feasibility, Initiation Visits, Monitoring (on-site/remote/central) and Close Out visits.
• Thorough knowledge of ICH-GCP, local regulatory requirements and clinical trial methodology.
• Strong interpersonal, written and verbal communication skills.
• Experienced working independently with limited oversight.

Personal qualifications

• A flexible attitude with respect to new assignments and a client-focused approach.
• Ability to manage multiple tasks and achieve project timelines while being able to apply your understanding of study protocol(s).
• Take pride in setting high expectations - to oneself and key collaborators.
• Previous experience from leading and mentoring team members is a plus.