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6 days old

Clinical Trials Regulatory Manager

CNS Network
Garden Grove, California

CNS Network is a clinical trials company with offices in Long Beach, Torrance, and Garden Grove is seeking a full-time Clinical Trials Regulatory Manager in Garden Grove. The regulatory function is responsible for overseeing with the organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, reporting on the status of various research tasks such as initial IRB submissions, continuing review, advertising materials, IND safety reports, SAE reports, deviation/violation reports, amendments, and close-out of studies. Hands on experience on managing people.

Job Descriptions:

  • Collaborate in the study selection process.
  • Maintenance of regulatory documents in accordance with applicable regulations.
  • Overseas the Coordination of required investigator and study staff training, collection and maintenance of in-date regulatory documents and profiles of investigators.
  • Additional responsibilities may include working directly with other research bases and/or sponsors. Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate.

Daily

Develop relationship with sponsors, CROs, monitors, investigators and CNS Network Staff in a professional and educational manner. 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 (ie CV etc), current IRB roster for each study

Oversee & Pre Site-Selection Visit

Assist in gathering pre-study documentation from investigators (ie CVs, questionnaires etc) and provide to sponsors in preparation for site selection visit. Follow up with monitor post visit on outstanding issues.

Post Site-Selection Activity

Participates in required training and education programs. Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies. Assist in training new personnel.

Education-:

Minimum of a Bachelor’s Degree

Experience-:

Minimum of 2 years previous Regulatory Management experience required.

We offer a competitive compensation and benefit package, including ESOP! 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

Experience:

  • Regulatory Management: 2 years (Required)
  • Clinical Trials: 2 years (Preferred)

Education:

  • Bachelor's (Preferred)

Work Location:

  • One location

Categories

Posted: 2019-05-15 Expires: 2019-06-14

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Clinical Trials Regulatory Manager

CNS Network
Garden Grove, California

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