Clinical Research Associate

NBCD; Town of Texas (WI); On-site; USD 70,000 - 95,000; Full time

Job summary

NBCD is a US-based CRO seeking a Clinical Research Associate to monitor trials and ensure patient safety, data integrity, and regulatory compliance across sites. You will conduct feasibility, site initiation, monitoring and close-out visits, while collaborating with Investigators and Study Coordinators; remote/home-based role with travel up to 75%.

The role offers exposure to global studies, provides opportunities to influence protocol design, and requires independent work with supportive

Qualifications

• Bachelor’s degree in biology, pharmacy, nursing or other health care related discipline.
• 2+ years of CRA experience with monitoring and site management activities.
• Knowledge of ICH-GCP, regulatory requirements and trial methodology.
• Strong interpersonal, written and verbal communication skills.
• Experience working independently with support from senior team members.

Responsibilities

• Conduct feasibility visits, site initiation visits, monitoring visits and close-out visits at assigned sites and generate visit reports.
• Ensure study quality on site through Source Data Verification/Review and drug accountability.
• Protect patients by safeguarding rights and well-being of subjects.
• Build relationships with Investigators and Coordinators to enable smooth collaboration.
• Develop recruitment strategies with sites to meet enrollment timelines and ensure SOPs/regulatory compliance.

Skills

CRA experience (2+ years)

ICH-GCP knowledge

Clinical trial monitoring

Remote work experience

Education

Bachelor’s degree in biology, pharmacy, nursing or other health care related discipline.

Job description

We are offering you a unique position as a key member in NBCD A/S, the leading Clinical Research Organization (CRO) specialized in Osteoarthritis.

NBCD A/S is currently looking for a US-based colleague to help strengthen our US footprint. As an expert full-service CRO, NBCD is conducting several studies in the US and we are currently looking for a Clinical Research Associate

About the position

As a 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 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.
• + 2 years of experience working as a CRA (or similar role within clinical research (SRC or alike)) with experience in ideally all monitoring and site management activities of the trial such as Site Feasibility, Initiation Visits, Monitoring (on-site/remote/central) and Close Out visits.
• Knowledge of ICH-GCP, local regulatory requirements and clinical trial methodology.
• Strong interpersonal, written and verbal communication skills.
• Experienced working independently with support from other more experienced team members.
• 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 working remote and with international teams

Are we a perfect cultural fit?

Our commitment to you is encapsulated in our promise to every one of our employees saying ‘Trust in you - in your development and impact´.

This pledge extends uniformly across all entities within the Sanos Group organization, including NBCD, ensuring that you feel its effects from the very offset of your interaction.

If you are curious about whether you would thrive within the Sanos Group culture and the Sanos Way of Leading, reflect on whether you see yourself working within our principles:

• Take on - Responsibility is given, and we inspire you to take it.
• Try out - Explore diverse tasks and grow professionally.
• Team up - We don’t just work together; we thrive together.

Want to know more? Check out the Voice of NBCD people here.

For further information about the role contact, Asger Bering Kristensen at [e-mail].

If you proceed in the recruitment process, you will go through a few additional steps where both you and we will assess whether this position is the right match for both parties. As part of the recruitment process, we use assessments to ensure the optimal match and the best foundation for future collaboration.

NBCD is dedicated to fostering a diverse and inclusive workplace. We believe that a variety of perspectives leads to better decision-making and innovation. We welcome applicants from all backgrounds and are committed to creating an environment where everyone can thrive.

We value your data and take care to protect it. Please see more information regarding privacy for job applicants here: https://nbcd.career.emply.com/privacy-policy

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