Senior/Lead Clinical Research AssociateAs a Senior/Lead Clinical Research Associate you are expected to function independently in all aspects of monitoring of the trial, but also to supervise and mentor junior team members. Depending on experience, you may also be expected to take on line management responsibilities.
As a team member with NBCD you will have multiple opportunities to quickly advance your career in clinical research through our career and mentoring program. Being a global company, NBCD will also provide a network of international colleagues you will be able to interact and collaborate with.
- Supervise and mentor junior team members.
- 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, pill count and review of the Investigator Study Files.
- 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.
- 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.
Minimum education and qualifications:
- Bachelor’s degree in biology, pharmacy, nursing or other health care related discipline.
- + 3 years of experience working as a CRA (or similar role) with involvement from all monitoring portions of the trial such as Site Feasibility, Initiation Visits, Monitoring and Close Out visits.
- Thorough knowledge of ICH-GCP, local regulatory requirements and clinical trial methodology.
- Strong interpersonal, written and verbal communication skills.
- Experience 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).
- Strong computer skills.
- Previous experience from leading and mentoring team members is a plus.
Work location: Remote/home based
Travel: The role requires travel up to 75%.
To apply please send your CV and a letter of motivation to email@example.com - we are looking forward to hearing from you!
For further information about the role contact Andreas Olofsson, Senior Director and US Head of CRO, at firstname.lastname@example.org. We are conducting interviews on a regular basis and will close the position when we find the right candidate.
We might use assessments as a part of the recruitment process.
We encourage all qualified candidates to apply for the position – regardless of ethnic background, gender, sexual orientation, disability, religion or age.
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NBCD is the leading clinical CRO specialized in Osteoarthritis in Europe. The Danish based company is now looking to expand its operation in US. Joining this expansive team at an early stage will give you opportunities to grow your career rapidly together with the US organization. The company has +30 years of experience working with clinical trials, biomarker development and precision medicine. Working closely together with the partners in the Sanos Group, NBCD serves as a one-stop shop for clinical trials in osteoarthritis and adjacent therapeutic areas.
For our permanent employees, NBCD offers a highly competitive package in terms of base and incentive compensation. In addition, we offer a comprehensive benefits program designed to support the health, wellness and financial security or our employees and their families. Benefits include medical, vision and dental coverage, 401(k) and more. The options for permanent employment or contracting will be discussed and agreed upon together with the candidate.