Come Join a Growing Company!
Do you have what it takes to be a GREAT Quality Assurance Specialist?
Quality Clinical Research is looking for Quality Assurance Specialist to join our growing research facility.
Position Highlights
Working at a top-ranked research company, the Quality Assurance Specialist works under the general direction of the Principal Investigator to ensure protocols are conducted in accordance with the principles of Good Clinical Practice. The Quality Assurance Specialist (QA) is responsible for the ongoing monitoring of clinical trial data for various studies. This position will concentrate on data accuracy and completeness, protocol adherence, and regulatory submission and documents management. The QA interacts directly with the site staff as issues arise. The primary skills include GCP proficiency, logical thinking, ability to prioritize, a can-do attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal, and team-building skills.
Qualifications
- Strong regulatory experience as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines
- Experience with data completion or familiarity with data form completion guidelines
- Excellent Verbal and written communication skills
- Full-time, 40 hours per week. Applicants must be available during normal business hours: (8:00 AM to 5:00 PM Monday through Friday).
- Excellent use of spoken and written English communication
- Ability to learn and use new technology and software
- Basic knowledge of medical terminology
- Have high ethical standards and professional honesty
- Friendly and outgoing demeanor
- 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 discrimination 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
Responsibilities
- This position will concentrate on data accuracy and completeness, protocol adherence
- Ongoing review includes study data, data submission and protocol compliance, adverse event monitoring, regulatory documents monitoring via our e-reg system
- The QA works directly with the study staff to review data in support of protocol reporting
- Data review - Reviews case report forms submitted for accuracy, protocol compliance and completeness
- Generates queries and submits them to the coordinator/data manager associated with the protocol
- General reporting Reports data summaries to the study team
- Perform other duties as assigned by Management
Job Type: Full-time
Pay: $17.00 - $19.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Ability to commute/relocate:
- Omaha, NE 68114: Reliably commute or planning to relocate before starting work (Required)
Experience:
- English: 1 year (Required)
- Computer skills: 1 year (Required)
Shift availability:
Work Location: One location