Clinical Affairs Specialist

4 weeks ago


Orange County, United States BioPhase Solutions Full time
Job DescriptionJob 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:
  • 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.
Manages the internal biocollection program, including:
  • 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
Qualifications:
  • 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
Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities

  • Orange County, California, United States BioTalent Full time

    POSITION SUMMARY The primary responsibility of the Senior Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The Sr. RAS is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product...


  • Effingham County, United States GeorgiaGov Full time

    Savannah Technical College is seeking a well-organized professional to serve as the Student Affairs Specialist. The Student Affairs Specialist is responsible for performing specialized duties in support of student affairs functions. This position will be based at the Effingham Campus, but may require travel to other Savannah Technical College campus...


  • Orange, United States University Of California Irvine Full time

    Reporting to the Director, Risk & Regulatory Affairs, the Accreditation & Regulatory Affairs Manager directs and coordinates accreditation, policy and regulatory affairs initiatives for UC Irvine Health; serves as the organizational liaison with The Risk, Compliance, Regulatory, Management, Specialist, Regulatory Affairs, Healthcare


  • Orange, TX, United States US Army Full time

    Public Affairs Representative- US Army Enlistment Required Enlist as a soldier into the United States Army and become a certified Public Affairs Mass Communication Specialist who participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and...


  • East Orange, United States Ladgov Corporation Full time

    Job Title: Clinical/Health Informatics SpecialistJob Description:We are currently seeking a highly skilled and experienced Clinical/Health Informatics Specialist to join our procurement team. As a Clinical/Health Informatics Specialist, you will play a critical role in providing quantitative support and expertise in data science, 'big data' analysis...


  • East Orange, United States Ladgov Corporation Full time

    Job Title: Clinical/Health Informatics SpecialistJob Description:We are currently seeking a highly skilled and experienced Clinical/Health Informatics Specialist to join our procurement team. As a Clinical/Health Informatics Specialist, you will play a critical role in providing quantitative support and expertise in data science, 'big data' analysis...


  • East Orange, United States Ladgov Corporation Full time

    Job DescriptionJob DescriptionJob Title: Clinical/Health Informatics SpecialistJob Description:We are currently seeking a highly skilled and experienced Clinical/Health Informatics Specialist to join our procurement team. As a Clinical/Health Informatics Specialist, you will play a critical role in providing quantitative support and expertise in data...


  • Johnston County, United States RESET Behavioral Solutions Full time

    Job DescriptionJob DescriptionThe Clinical Support Specialist at Reset Behavioral Solutions plays a vital role in providing comprehensive and evidence-based support to individuals in our care and their respective teams. This multifaceted role involves close collaboration with day program staff, group home staff, families, and direct support staff to ensure...


  • Durham County, United States Department Of Veterans Affairs Full time

    Summary **This announcement is also for clinics within the Durham VAHCS including Raleigh 1&2, Greenville N.C.** The Advanced MSA, provides specialized and expert administrative patient support while working collaboratively in an interdisciplinary coordinated care delivery model. Work...


  • Orange County, United States ABA Your Way LLC Full time

    Job DescriptionJob DescriptionWhy Work with UsAt Aba Your Way we believe in both staff and client success above all else. Our contemporary approach is person-centered and believes that anything is possible. We believe in Aba reform. We support change in the delivery of behavior analytic services and that it begins with us.Every learning opportunity is client...


  • Meade County, United States Veterans Health Administration Full time

    Summary The incumbent serves as a Medical Administrative Specialist- Health Administrative Specialist on Duty (HOD) located in the Office of the Chief, Health Administration Service (HAS), or Business Office (BO), or Medical Administration Service (MAS), or similarly named and organized service; the position has both the authority and responsibility to...


  • Los Angeles County, CA, United States Los Angeles County Department of Human Resources Full time

    The County of Los Angeles Department of Health Services is seeking to fill the position of Chief Deputy Director, Clinical and Medical Affairs. This position is responsible for directing the planning, administration and management of multiple, complex and sensitive functions across the Department of Health Services (DHS) with general direction from the DHS...


  • Orange, California, United States V Group Inc Full time

    Job Title: Grievance and Appeals Nurse SpecialistCalOptima Health is seeking a highly motivated an experienced TEMP - Grievance & Appeals Nurse Specialist to join our team.The Grievance and Appeals Nurse Specialist participates in managing CalOptima Healths medical appeals and state hearing reviews for all lines of business, including handling expedited and...


  • New York County, New York, United States Memorial Sloan Kettering Cancer Center Full time

    Pay Range: $98,500.00-$(phone number removed) Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists...


  • New York County, New York, United States Memorial Sloan Kettering Cancer Center Full time

    Pay Range: $(phone number removed)-$(phone number removed) Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering...


  • Orange City, United States Gastro MD Full time

    Job Description: Patient Services SpecialistLocation: Orange City Clinic, Orange City, FloridaAs a Patient Services Specialist, you will be the first point of contact for our patients and visitors at the Orange City Clinic. You will greet them with a smile, answer their questions, and assist them with their needs. You will also handle various administrative...


  • East Orange, United States The Center for Great Expectations Full time

    Job Type Full-time Description Peer Recovery Specialist, START Program Support for mothers with substance use disorders and their children in the community Monday-Friday, 9am-5pm with flexibility in the evenings as needed for recovery meetings Under the supervision of the Site Manager, the Peer Recovery Specialist is responsible for outreach to...


  • Orange City, FL, United States Gastro MD Full time

    Job Description: Patient Services Specialist Location: Orange City Clinic, Orange City, Florida As a Patient Services Specialist, you will be the first point of contact for our patients and visitors at the Orange City Clinic. You will greet them with a smile, answer their questions, and assist them with their needs. You will also handle various...


  • Macomb County, United States McLaren Medical Group Full time

    Responsible for the operation of multiple ambulatory sites, implementation of strategic plan and mission, employee and patient experience, financial performance of sites, improvement of quality of services, coordination and integration of services with McLaren Health Care subsidiaries. Provides leadership support to Senior Director of Operations, Clinic...

  • Crisis Specialist

    2 weeks ago


    Marin County, United States County of Marin California Full time

    We have an on-going need for extra-hire employees in our Crisis Stabilization Unit, Mobile Crisis Continuum and with Jail Mental Health Services for Crisis Specialists and/or Licensed Crisis Specialists. In addition, if the position includes the belo Specialist, Licensed, Associate, Behavioral Health, Mental Health, Clinical, Healthcare