Sr. Clinical Research Associate
San Rafael, CA | Contract
Bayside Solutions is seeking a Senior Clinical Research Associate 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 atwww.baysidesolutions.com.
Senior Clinical Research Associate
- 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:
- Establishes and manages timelines for assigned study while considering strategic objectives and corporate priorities.
- Leads the preparation and finalization of clinical study documents including, but not limited to: protocols, Informed Consent Document templates, eCRF Completion Guideline, Monitoring Plans, etc. Set-up and management of sponsored study documentation in official repositories (e.g., electronic systems).
- Participates in or leads the planning and execution study meetings (i.e., study team meetings, advisory boards, investigator meetings, etc.).
- Participate with Study Lead on study feasibility assessments activities.
- Periodically reviews adverse events and data listings, works with Pharmacovigiliance, Medical Monitor and colleagues on reconciliation.
- Oversees required communication to site staff or designee regarding issues identified during reconciliation.
- Manages data discrepancies for the entire study and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established time frame for resolution.
- Manages laboratory specimen collection process where applicable including interfacing with the company’ s laboratory and vendors.
- Ensures supplies for specimen collection are adequate at the site and site staff is trained on collection and shipment process.
- Participates in the selection and management (i.e., contracts, budgets, tracking of planned vs actual spend) of study vendors as applicable.
- Facilitate short and long term planning for assigned studies.
- Works with Directors or designee on budget planning process for assigned study.
- Develop and implement contingency planning with Directors' or designee support.
- Creates clinical study metrics and other management reporting tools.
- Identifies problems/issues and reports findings to Directors or designee.
- At least 5-7 years’ experience as a Clinical Research Associate.
- Experience in the management of multiple sites as a Clinical Research Associate is preferred.
- Extensive experience with study design, planning and implementation.
- Study documents writing experience (i.e., protocol, ICD templates, eCRF Completion Guidelines, Monitoring Plans, etc.).
- Advanced verbal and written communication skills, in addition to excellent organizational skills and management of cross-functional teams.