Quality Assurance Specialist (Onsite) Job at Meridian Clinical Research
For over 20 years, Meridian has partnered with pharmaceutical and biotechnology companies to research new drugs, medical devices, and diagnostics to help improve lives. The level of service, quality, and integrity we provide makes Meridian unique, but our reputation is great because of our people. Clinical research is tremendously challenging, yet it is incredibly rewarding. We value our employees for being all in, owning it, their teamwork, and sharing it. If you're searching for a career with purpose, integrity, and opportunity, then we want to hear from you!
Quality Assurance Specialist
The quality assurance specialist is responsible for assuring the accuracy and integrity of clinical research activities and compliance with U.S. Food and Drug Administration (FDA) regulations, the International Conference of Harmonization Good Clinical Practice (ICH GCP), and institutional standard operating procedures (SOPs) while at all times protecting the rights, safety and welfare of study volunteers within the Meridian network of sites.
Generous Full-Time Employee Perks:
- Tuition reimbursement and student loan debt assistance after your first year of employment
- 3 weeks of paid time off (accrual basis)
- 7 paid holidays each year
- Yearly shared employee bonus program after your first full year of employment
- 401k with company match after 90 days of employment
- 100% employee-only coverage paid on our medical health savings account plan, for other options, employer contributions are between 28%-65% based on the coverage level and plan you choose.
- Medical insurance opt-out option: $100/month taxable payment option for employees that provide proof of medical coverage elsewhere, if they choose to waive Meridian's medical insurance.
Responsibilities
Compliance
- Review all clinical research associate (CRA)/monitor follow-up reports/letters for each site visit from the sponsor or clinical/contract research organization (CRO). Ensure that action items are completed and a resolved response has been sent to the CRA in a timely manner.
- Assist sites with compliance issues identified in the reports; write corrective and preventative action (CAPA) plans and Notes to File as necessary.
- Review charts and Trial Master Files to ensure internal compliance:
o At SIV
o At Study Closeout
o Oversight Visits
o Before sponsor audit
o Before FDA inspection
o Protocol deviation identification and tracking.
o Standard Operating Procedures
- Assist with annual review and revisions of Standard Operating Procedures
Training
- Lead training for Meridian staff
- Train on GCP, federal regulations, SOPs, guidelines, and other relevant documents for investigators and research staff (directors, coordinators, assistants, etc.)
- Train on source document completion
- Train on Delegation of Authority Log
- Perform other duties as assigned
Requirements
- Experience as a Clinical Research Coordinator (CRC) or equivalent experience on the site level coordinating clinical trials.
- Medical background (RN, PA, MT, EMT) degrees preferred with clinical research experience required and can be used in lieu of degree.
- Excellent oral and written communication skills.
- Demonstrated ability to work well both independently and with subordinates.
- Demonstrated ability to manage frequent deadlines and competing priorities.
- Computer proficiency.
- Regular and punctual attendance.
- Perform other duties as assigned.
- Embrace Meridian’s core values: “All In, Own It, Teamwork, Share It”
Travel Requirements
- Travel may be required on an as-needed basis for this position.
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 15 pounds at times.
- Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
- Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
- Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Meridian not only strives to move science forward and improve the lives of others, but we focus on improving the lives of our people by offering a competitive benefits package to all full-time employees. Meridian's benefits package includes eligibility for medical insurance, dental insurance, vision insurance, 401k with company match, seven paid holidays, paid time off, student loan reimbursement program, complimentary life insurance, disability insurance and so much more!
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