What are the responsibilities and job description for the Clinical Research Associate/Clinical Affairs Associate position at UroMems?
Company Information
UroMems, based in Grenoble, France with offices in Grenoble, Paris and Minneapolis, is recruiting for a US based Clinical Research Associate/Clinical Affairs Associate to manage day-to-day clinical operational activities in the next-stage clinical evaluation of its novel products.
Role
The Clinical Research Associate /Clinical Affairs Associate will be responsible for all the administrative aspects of the trials including handling documentation, regulatory paperwork, and other logistics for clinical trials. The Clinical Research Associate/Clinical Affairs Associate will work closely with other members of the Clinical Affairs team including Clinical Project Managers (CPM), Data Managers and other Clinical Research Associates/Clinical Affairs Associates. Additionally, he/she will support participating sites in the ongoing execution of clinical trials.
Key Responsibilities
- Develop study documents and tools including Informed Consent Form (ICF) templates (for IRB submissions), site binders, etc.
- Ensure that all required site regulatory documents and approvals are in place prior to authorizing a site to enroll
- Conducts routine reviews to ensure that all site documentation, as filed in Trial Master Files, is adequate and audit ready
- Works closely with field CRAs and data management to resolve data queries, as needed
- Assists with efforts related to subject recruitment, device shipping, and site payments
- Collaborate with cross-functional teams including clinical affairs associates, data managers, biostatisticians, and other key stakeholders
- Create and maintain solid relationships with academic and research institutions, clinical site staff and KOLs
- Collaborate with International teams on the overall planning and implementation of clinical trials
- Manage relationships with external vendors including CROs, and other service providers.
- Oversees data quality and integrity throughout the trial
- Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
Qualifications
Education:
- Bachelor’s degree in life sciences, pharmacy, nursing, or a related field
Experience/Skills:
- 2-5 years of clinical research experience (Medical device or related field is preferred)
- Strong organizational skills and the ability to multitask and work effectively in a fast-paced environment
- Excellent communication and interpersonal abilities
- Understanding of GCP, ICH guidelines, HIPAA and regulatory compliance
- Ability to collaborate effectively with international teams across diverse cultural backgrounds
- Analytical and problem-solving skills, with attention to detail
Other
Legal authorization to work in the U.S.