Sr Staff Clinical Research Associate REMOTE
Remote Southern CA San Diego, CA 92101 US
Provides clinical support for diagnostic product development to achieve clearances and approvals in the US and internationally. Provides clinical trial site management and assures successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures. Reviews, assesses and interprets data from ongoing and completed studies. Conducts clinical compliance activities. May be responsible for multiple clinical studies
- Responsible for the day to day management of clinical trial sites across multiple clinical projects.
- Identifies and builds relationships with external clinical sites.
- Manages multiple clinical trials in parallel including investigator selection, analysis of potential enrollment, preparation of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements, etc.) and organize investigator’s start-up meetings.
- Works with business development to contract external sites, as required.
- Submits protocols and other documents to Institutional Review Boards / Ethics Committees with follow through to ensure successful outcome.
- Monitors the assigned clinical trials following company SOPs and in accordance with GCP and all FDA and applicable international regulations concerning clinical trial activities.
- Assists in preparation of study-specific binders, logs and forms.
- Plans the requirements for clinical trial material, orders clinical trial material, sets up and monitors the systems whereby the clinical project coordinator can ship clinical trial material to the investigator, maintains procedures to account for the clinical trial material, checks the expiration of clinical trial material and requests extensions if necessary.
- Manages enrollment strategies to meet study requirements (e.g., investigator and study coordinator meetings, newsletters, advertising, etc.).
- Coordinates shipment of clinical samples and the resulting data when central laboratory facilities are used.
- Tracks completed CRFs and sets up systems whereby completed CRFs are rapidly entered into the database. Ensures that queries generated during data cleaning are responded to in a timely fashion.
- Evaluates clinical data/information and prepares reports as required.
- Participates in conference calls and meetings to review progress of ongoing clinical trials.
- Reviews all UADEs, ensures appropriate approvals are obtained, that sites are notified and that all company procedures are complied with.
- Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; package insert and user guides; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
- Participates in the conduct of internal and external audits and inspections of clinical studies.
- Participates in departmental planning sessions, and SOP development.
- Mentors junior CRAs to promote departmental skill base.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
- Industry experience within in-vitro diagnostics required.
- Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Strong written and verbal communication skills; demonstrated ability to organize and present scientific information (e.g., clinical study results) to internal and external audiences.
- Familiarity and ability to work with office automation programs and corporate database tools.
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Minimum 5 years experience; NGS IVD experience preferred, but not required. Candidate must possess IVD testing CRA experience. Candidates with less than 5 years of CRA experience, but strong IVD experience, will be considered
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
CO / NY candidates may not be considered.
79-89 pay rate range
**salary will be commensurate with experience**
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