Regulatory Quality Control Specialist

3 weeks ago

San Diego, United States Alliance Clinical Network Full time

**SUMMARY**:The Regulatory QC Specialist is responsible for ensuring research compliance with protocols, federal regulations, industry guidelines and company Standard Operating Procedures. This position requires ongoing knowledge of GCP/ICH guidelines and the federal regulations related to conducting clinical trials.

**ESSENTIAL DUTIES AND RESPONSIBILITIES **include the following. Other duties may be assigned**.**

1) Comply with all company policies, procedures, and conduct.

2) Strictly adhere to confidentiality and compliance standards.

3) Create, Maintain, Evaluate & Implement QA Plan/Policies for conducted studies.

4) Review and audit of protocols, informed consents, source data, data entry, case reports forms (CRFs) and regulatory documents for accuracy and compliance.

5) Provide consistent feedback to study coordinators and managers to ensure compliance.

6) Review/audit of recruiting documentation.

7) Perform in-clinic audit of study procedures and study material receipt and return/ destruction to ensure all sites are ready for inspections and audits.

8) Assist with documentation of non-conformities, corrective actions, and preventive actions.

9) Oversee final review of regulatory and study documents prior to archiving.

10) Maintain knowledge of company Standard Operating Procedures (SOPs) to be able to review and ensure SOP compliance.

11) Assist with auditing the company training files.

12) Assist with training of new departmental staff on SOPs, policies, regulations, and guidelines associated with clinical research.

13) Work with all involved parties to ensure that both the equipment, lab safety and operational needs are met, and calibration is current.

14) Encourage prompt reporting of health and safety concerns.

15) Must have excellent organizational, attention to detail, interpersonal skills, and possesses a high level of multi-tasking capacities.

**EDUCATION and EXPERIENCE**:
1) Associate’s degree in healthcare or related field, preferred.

2) 2 years’ experience in running research protocols, required.

3) 2 years’ experience in FDA regulations and GCP.

4) Proven track record of analytic reasoning skills and problem solving.

5) Exceptional attention to details and organization.

6) Must possess excellent verbal and written communication skills.

7) A proven ability to multi-task in a rapidly changing environment.

Pay: $27.00 - $29.00 per hour

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Experience level:

- 2 years

Schedule:

- Day shift
- Monday to Friday

Work setting:

- In-person

Ability to Relocate:

- San Diego, CA 92120: Relocate before starting work (required)

Work Location: In person

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