[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. NBCD A/S is a leading Clinical Research Organization (CRO) specialized in Osteoarthritis, seeking a Senior Clinical Research Associate to strengthen their US operations. The role involves conducting site visits, ensuring study quality, and developing patient recruitment strategies while collaborating with clinical sites.

Responsibilities

• 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

Skills

• 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
• 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

Benefits

• For our permanent employees, NBCD offers a competitive package in terms of base and incentive compensation.
• 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.

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