GENERAL SUMMARY OF DUTIES – – Review and verify documentation of study participant research data to ensure compliance with study protocols. Identify discrepant data capture for escalation and resolution for final approval. Ensure study requirements are followed in accordance with sponsor expectations along with company processes and procedures. In addition to these duties, work with, lead, and task assist the Quality Department Team on other projects as assigned.
MANAGER- Quality Assurance Manager; Quality Director
SUPERVISES - N/A
DUTIES INCLUDE, BUT ARE NOT LIMITED TO:
- Perform duties and job responsibilities in a manner that supports the mission, vision, and culture of the company.
- Communicate and coordinate with all staff levels to assure alignment of strategies, goals, and policies
- Delegating tasks to QAA’s and Data Entry Assistants; ensuring goals of accuracy and timeliness are met
- On-going education and training of other QA staff regarding protocol specific tools, updates, roles, responsibilities and expectations
- Work closely with management in maintaining a positive and productive work environment
- Assist the QAM in planning, creating processes and training's
- Other duties as assigned
Data Coordination responsibilities:
- Reviews study data captured in subject study binders to ensure compliance with protocols and other sponsor requirements for the duration of the trial
- Review study-related source documentation captured by Clinical Operations such as intake forms, visit worksheets, treatment histories, medical histories, clinical notes, laboratory results, ECG interpretations, medical records, adverse event reports, delegation logs, deviation logs, sponsor correspondence, sponsor-issued newsletters and memos, institutional review board documents
- Identify discrepant data capture and verify appropriate corrections are made for any incorrect, missing, or incomplete data through confident, knowledge-based conversations with the leadership team, study investigators, and other appropriate study staff
- Source-data verify subject eligibility prior to their scheduled randomization or baseline visits
- Verifies subject safety and site adherence to FDA regulations, ALCOA-C, ICH/GCP guidelines and protocol-specific requirements.
- Responsible for quality control and assurance and preparation for site monitoring visits, FDA audits, and sponsor audits.
- Maintains accurate progress reports and other spreadsheets for tracking status of QA review and approval.
- Contribute to and maintain QA department metrics and performance metrics for Clinical Operations staff
- Ensures correction and final approval of discrepancies noted in research data.
- Identifies and assists in developing training programs for study staff and supporting departments based upon review metrics.
- Collaborates with site investigators, clinical research coordinators, and other research staff to ensure all protocol guidelines have been completed appropriately.
- Other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:
- Knowledge of clinical trials and study protocols as they pertain to pharmaceutical research
- Knowledge of ICH-GCP guidelines
- Knowledge of ACLOA-C guidelines
- Knowledge of medical terminology
- Accuracy, thoroughness and attention to detail is imperative
- Skill in reviewing and maintaining records
- Skill in Microsoft Word, Excel, including other other software systems and technology
- Skill in developing and maintaining effective working relationships with quality and research staff
- Ability to maintain client confidentiality
- Ability to effectively present study information
- Ability to present a positive image of the clinic
- Ability to work independently as well as within a team
- Ability to communicate clearly both orally and in written form
- Ability to escalate critical issues or concerns timely an accurately
- Ability to effectively communicate with peers, physicians, and leadership
- Skill in time management and execute workload with minimal supervision
- Ability to foresee potential issues and accurately communicate with the study team to ensure study deadlines are met
EDUCATION – Bachelor’s degree required
The ideal candidate will be an independent, critical thinker with strong attention to detail. The ideal candidate must also be willing to adhere to the 7 guiding principles of our company.
CERTIFICATE/LICENSE –Certification in Good Clinical Practices desired, CPR training provided
PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00a.m. to 4:30p.m. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.
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