Clinical Research Associate
| Company | Insulet Corporation |
|---|---|
| Location | Acton, MA, USA, San Diego, CA, USA |
| Salary | $85575 – $128362.5 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- B.S. or B.A. and/or an equivalent combination of education or experience.
- CRA certification
- Minimum of 3 years of experience.
- Available to travel on short notice and independently manage travel schedules.
- Direct experience in participating in the execution of clinical research studies.
- Must have analytical skill, be detail oriented and have good interpersonal skills.
- Knowledge of agency guidelines and requirements.
Responsibilities
- Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study.
- Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.
- Create consent and assent templates specific to the needs of the planned study.
- Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent.
- Train site staff on protocol requirements, source documentation, and case report form completion.
- Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent/assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments.
- Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
- Coordinate project meetings.
- Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc.
- Participates in team meetings and tracks action items.
- Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Performs other duties as required.
Preferred Qualifications
- Excellent written and effective verbal communication skills. Bilingual English and French is preferred.
- Ability to communicate at all levels of an organization.
- PC skills; word processing, spreadsheet, database, Internet search and utilization.
- Flexible and able to work in a fast-paced environment.
- Team player.
- Ability to organize and judge priorities.
- Excellent ability to generate and maintain accurate records.