- working closely with R&D and Operations personnel and external clinical research organizations (CROs) on clinical studies
- managing investigational devices and clinical study supplies
- participating in the clinical study site initiation
- performing on-site and remote/virtual monitoring activities including interim monitoring visits or closeout visits
- organizing all applicable records for clinical studies and clinical samples,
- verifying source data/documents and other clinical study records are accurate, complete, and maintained
- monitoring the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and act when necessary
- monitoring IRB activities, including additional site submissions, amendments/changes in research submissions, facilitating submission of annual continuing review reports, monitoring and notifying of document expiration dates, and process fees through accounts payable.
- ensuring all activities are conducted in accordance with all applicable regulatory requirements, Good Clinical Practice (GCP) guidance and company policies and procedures.
- drafting or updating biocollection protocols
- maintaining IRB approval of the biocollection program
- collecting and managing samples under the biocollection program (e.g., nasal swab samples, urine, saliva, etc.), including addressing R&D requests and managing the check-in/ check-out of stored specimens
- collecting and maintaining all the records for the biocollection program
- Safeguards the clinical samples, clinical data and records, ensuring that the confidentiality, integrity and security of the clinical samples and clinical records are maintained, and PHI information is protected
- Maintains all regulatory, legal, and financial disclosure documents per guidelines and regulations of the sponsor and IRB
- Supports regulatory inspection activities
- Works on other projects within QA & RA not related to clinical studies as assigned by management
- Bachelor's degree in life sciences or related discipline, or RN required with a minimum of 4 years of clinical study experience, or advanced degree with a minimum of 2 years of clinical study experience, in a regulated environment (CLIA or FDA regulations)
- Experience with conducting clinical studies within the medical device, pharmaceutical, or biotechnology industry
- In-depth knowledge of FDA regulations and ICH Guidelines on clinical studies
- Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors
- Ability to carry out monitoring of investigator sites and clinical research vendors. Requires an in-depth knowledge of monitoring principles, techniques, and communication skills to clearly and efficiently convey findings and report deficiencies
- Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook
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Description
Job Description
Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Clinical Affairs Specialist to work for an Orange County area medical device company.Salary: $70-95kResponsibilities:Supports the external clinical studies, including:
