FirstWave offers great opportunities for Clinical Research Associates (CRAs). We employ CRAs on projects spanning the globe and have part home-based positions for those with the right experience. We offer increased income potential, outstanding career progression and exposure to cutting-edge technology with projects in the Medical Devices, Pharmaceutical & Biotechnology Industries.
A career at FirstWave provides many opportunities for CRAs:
- Comprehensive clinical foundations training
- Strong therapeutic and project-specific training
- Hands-on training through accompanied field visits with experienced CRAs and managers
- Strong support network from clinical management
- Regular performance reviews and career progress discussions with clear pathways to meet career goals
- Opportunities to advance within the CRA sector or progress into a management position
CRAs play a vital role in meeting our commitment to our clients. They may be responsible for:
- Identifying potential investigators in collaboration with the client.
- Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards.
- Monitoring the trial throughout its duration, which involves visiting the trial sites (incl all involved departments) on a regular basis.
- Having good knowledge of the investigational medicinal product and ensuring monitoring of shipments, dispensation and returns at the pharmacy departments.
- Reviewing study case report forms (CRFs) completed by the investigative sites towards the source data (SDR/SDV activities), and verifying entries by validating accurate source documentation to support CRF entries.
- Documenting site visits and issues in reports and follow-up letters to the site.
- Ensuring all unused trial supplies are accounted for.
- Closing down trial sites on completion of the trial.
- Discussing results with a medical statistician, who usually writes technical trial reports.
- Liaising with investigators on conducting the trial.
- Facilitating effective communication among investigative sites and the client.
- Responding to company, client and federal regulatory requirements/audits.
- Contributing to the project team by mentoring new members, assisting in preparation of project communications and tools, and sharing ideas and suggestions with team members.
- Monitors are trained to follow the current ICH-GCP guidelines.
Additional information:
- Career opportunities include the following positions:
- CRA II
- Lead / Senior CRA
- Jr Clinical Project Manager
- Clinical Project Manager
- Sr Clinical Project Manager
Qualified candidates possess a bachelor's or a Masters’ degree in life sciences. A minimum of two years of experience in a clinical trial environment is required. Individuals with at least two years of experience in a health sciences field with formal training in medical terminology and anatomy will be considered. Travel can range from 20-60% on a national level or dependent on the project up to 80% international travel.