Regulatory Affairs Coordinator (clinical trial/research required)

We are growing and looking for the perfect candidate to fill our vacant Regulatory Affairs Coordinator position.

We would love to speak to you if you have:

  • Relevant work-related regulatory experience in Clinical Research.
  • Coordinated multiple projects simultaneously with tight deadlines.
  • Good business acumen with a sense of urgency.

As a Regulatory Affairs Coordinator , you are responsible for assisting with the organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks. You will maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.

Essential Responsibilities and Duties:

  • Provide guidance to lower-level personnel involved in the planning, implementation, and evaluation of clinical studies.
  • Create and maintain the regulatory bin in accordance with the following industry guidelines.
  • Verify that the regulatory bin for the study is complete through daily communication with coordinators and regular contact with sponsors and IRB on an as-needed basis.
  • Maintain training records of study staff and investigators.
  • Update physician profiles of each investigator (CV, DEA license, medical license, debarment, etc.).
  • Maintain current investigator credentialing (i.e., CV etc.), current IRB roster for each study.

Minimum Qualifications:

  • Bachelor's in Business Administration, Health Science or of related field.

Or

  • An equivalent combination of education and experience sufficient to successfully perform the job's essential duties such as those listed above.
  • Relevant work-related regulatory experience in Clinical Research.
  • Demonstrated good business acumen with a sense of urgency.

We offer a competitive pay package which includes but not limited to:

  • PTO/Holiday
  • Company-wide Bonus
  • Medical/Dental/Vision
  • 401(k)/Dependent Care FSA/EAP
  • Ancillary Benefits/Group Life Insurance/ AD&D
  • Employee Engagement Activities/Employee of the Month

COVID-19 precautions

As of August 5, 2021, California State Public Health Officer Order required workers in healthcare settings to be fully vaccinated, with exemptions to religious beliefs or qualified medical reasons, by September 30, 2021.

** CNS requires all employees to be vaccinated for COVID-19. As an equal opportunity employer, we will consider a request for reasonable accommodation based on disability or sincerely held religious beliefs possible without undue hardship. **

  • Personal protective equipment provided or required.
  • Social distancing guidelines in place.
  • Sanitizing, disinfecting, or cleaning procedures in place.
  • A negative COVID-19 test result is required weekly for individuals who meet the exemption qualification.

About Collaborative Neuroscience (CNS) Network

CNS Network was founded in 2000 and has grown to become one of the largest clinical research providers in the country and the largest in Southern California. CNS operates three outpatient clinics in Southern California, a dedicated Phase 1 Unit, and a JCAHO-accredited Psychiatric Health Facility (PHF). In addition, in partnership with major pharmaceutical sponsors, CNS conducts clinical trials for new medications and treatments in various therapeutic areas, including neurology, psychiatry, and general health conditions.

If you are interested in working alongside a successful and dynamic team and you meet the following qualifications, we are interested in you! CNS Trials is an equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

Job Type: Full-time

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Experience:

  • Clinical research regulatory: 1 year (Preferred)
  • Clinical Research/Clinical Trials: 1 year (Preferred)

Work Location: One location

Company
CNS Network
Posted
11/24/2021
Location
Garden Grove, CA 92641, US
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