Novato, CA | Contract
Bayside Solutions is seeking a Senior CRA to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The Sr. CRA will perform clinical research duties within Global Medical Affairs, Study Management including but not limited to: protocol development, planning, implementation, conduct/oversight (i.e., meeting facilitation), site co-monitoring, site management, project tracking (timeline and budgets) and vendor management.
- Confirms the qualifications of investigators, and investigational sites throughout the conduct of a clinical study and assesses adherence to applicable regulatory requirements (e.g., ICH/GCP, CFR and country specific).
- Oversee CRO CRAs to ensure monitoring is completed according to study Monitoring Plan.
- Participates in co-monitoring visits for training opportunities with CRO CRAs.
- Leads or participates in the preparation and finalization of study documents including, but not limited to: Informed Consent Form templates, periodic/interim/ annual/final reports and statistical analysis plans. Set-up, over site and reconciliation of study documentation in official repositories (e.g., electronic systems).
- Periodically reviews adverse events reported in the study and works with
- Manages laboratory specimen collection and reconciliation process where applicable including interfacing with laboratory and vendors.
- Ensures supplies for specimen collection are adequate at the site and study/site staff are trained on collection and shipment processes.
- Vendor Management: Participates in the selection & management (i.e., contracts, change orders, budgeting, tracking of planned vs actual spend) of study vendors as applicable.
- Creates clinical study metrics and other study management reporting tools.
- Bachelor’ s degree, preferably in a scientific field.
- At least five years’ experience as a Clinical Research Associate.
- Vendor management.
- Excellent verbal and written communication skills, in addition to excellent organizational skills.
- Ability to travel is required.
- Preferred: post-approval observational research experience.