Intellijoint is seeking a Clinical Research Assistant to assist with the collection, analysis and publication of clinical and economic data in our growing Clinical Research team. Reporting to the Director, Clinical Programs, the Clinical Research Assistant is responsible for supporting our Research Associates by managing the study start-up process and documentation maintenance for pre- and post-market studies. We are looking for someone with a strong background in clinical research methodology who is able to work both independently and collaboratively.
Talented individuals looking to grow their career with a growing start-up and meet the criteria below are encouraged to apply:
Job Duties and Responsibilities
- Coordinate the development of clinical study documents, including but not limited to: study protocols, case report forms, investigator brochures, informed consent documents, project plans, budgets, etc.
- Coordinate implementation of study agreements with study sites.
- Prepare Institutional Review Board submissions and liaise with study site IRB personnel and manage approval process.
- Manage submission and tracking of abstracts for orthopaedic conferences in North America and worldwide.
- Participate in the analysis, summary, and reporting of clinical data for regulatory, marketing, or other purposes.
- Maintain awareness of regulations and guidance documents concerning clinical evaluations ensuring organizational compliance.
- Provide study specific training to members of the clinical study team, as needed.
Required Skills and Experience
- Bachelor’s degree in a health-related field.
- 1-2 years of experience in clinical research.
- Working knowledge of the clinical research process, Good Clinical Practices, Compliance Requirements, FDA regulations governing clinical trials, and international standards for clinical studies.
- Must be capable of working with individuals internally and externally, ranging from investigators, facility managers and administrators to critical function areas, such as regulatory affairs, marketing, service and support, project management, R&D and manufacturing.
- Working knowledge of orthopaedic market and joint replacement surgery.
- Experience with surgical guidance technologies.
- Knowledge of US and Canadian health care systems, reimbursement and regulatory requirements in North America and worldwide.
Soft Skills and Key Characteristics:
- Strong organizational, inter-personal, and communication skills (written and oral).
- Able to function in a self-directed manner with high degree of independence.
- Ability to plan and prioritize.
- Creative problem solver.
- Attention to detail.
- Adaptable to various duties as necessary in a start-up environment.
- Team player.
To apply, please visit our job board. We thank you for your interest in Intellijoint Surgical; only selected applicants will be contacted for an interview. We look forward to hearing from you.