Quality Control Associate

Pinnacle Clinical Research • San Antonio, TX

11h • Hybrid

About The Position

The Quality /Regulatory Associate will perform independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to the protocol, standard operating procedures (SOPs), GCPs and the reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). The Quality/Regulatory Associate is responsible for building and maintaining effective working relationships with internal staff/external vendors. The ideal candidate will be responsive, thoughtful, self-motivated, highly organized, and a team player. This role reports directly to the VP of Compliance. Under the supervision of a mentor/coach, the Quality/Regulatory Associate will be responsible for:

Requirements

• Bachelor’s Degree in a scientific area of study or equivalent combination of education, training, and experience.
• Previous experience in a clinical research environment or equivalent work environment.
• 2-4 years of previous experience as a regulatory and/or quality associate in clinical research.
• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
• Familiarity with clinical trial management system software, preferably Clinical Research IO.
• Basic medical knowledge, including medical terminology.
• Demonstrated competence in oral and written communication.
• Must complete CITI and GCP training certification.
• Demonstrated organizational skills and outstanding time management, including keen attention to detail.
• Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission.
• Comply with the company policies, code of ethics, and guiding values at all times.
• Strong analytical and problem-solving skills.
• Detail-oriented with the ability to perform at a high level of accuracy.
• Proactive in identifying and addressing issues in real time.
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner.
• Must handle confidential matters and sensitive information with discretion and judgment.
• Ability to research regulatory issues and provide recommendations for resolution.
• Ability to handle multiple projects simultaneously.
• Ability to manage small projects and work independently.
• Ability to understand and interpret clinical research protocols and other applicable sponsor documents.

Nice To Haves

• Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred.

Responsibilities

• Perform quality control checks on study documents related to the conduct of the clinical trial in different therapeutic areas and phases.
• Audit phases of laboratory and clinical studies, reports, and perform related duties (e.g., issues findings and QA statements).
• Support training for site staff, including creating and presenting quality content.
• Audit all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services).
• Assist with writing QA audit or QC reports.
• Work with the internal clinical research team to ensure that inspection findings are clearly communicated and understood.
• Evaluate inspection finding responses to ensure they are written to address the findings appropriately.
• Ensure, through phase and data inspections, that the SOPs, which are involved in the conduct of a study, are current and practiced.
• Introduction to in-life audits, process audits, and vendor audits.
• Identify and communicate opportunities for process improvement based on audit and inspection observations.
• Maintain necessary documentation of QA records and study files.
• Notify management of observed quality and compliance trends in the areas inspected.
• Interpret GCP, and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Carry out appropriate self-development efforts as directed.
• Perform other related duties as assigned.
• Ensure that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices regarding the conduct of clinical pharmaceutical and device protocols.
• Maintain subject and document confidentiality, understand and comply with the appropriate sponsor requirements, regulations, including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures.
• Work under limited supervision to ensure compliance with federal regulations relating to human subject research.
• Understand and apply ethical principles and multiple regulations to clinical research protocols.
• Review study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements.
• Prepare, maintain, and provide oversight to all research-related regulatory documents.
• Populate and coordinate the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary.
• Compile study information and submit initial, continuing, and final reports to the IRB and/or sponsor.
• Prepare applicable submission forms and submit updated documents, including but not limited to amendments, addenda, investigator's brochures, safety information, Form FDA 1572s, and informed consent documents.
• Accurately file and maintain all necessary logs within the regulatory binder(s), assist in and manage the archival of clinical trial documents/records.
• Prepare for monitoring visits and audits.
• Manage and update employee curriculum vitas and ensure copies of all current and applicable medical licenses are on file.
• Create error-free written documents and reports such as cover letters, notes-to-file, and memos.
• Exercise judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction of the study Investigator and supervisor.
• Interact with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients, and attend site initiation visits.
• Coordinate multiple projects with competing priorities and deadlines, as needed, based on clinical trial protocol directives and study volume.
• Other duties as assigned.

Benefits

• 401k
• Medical, dental, vision, long-term disability, short-term disability, HSA, and life insurance
• 3 weeks of paid time off
• 13 paid company holidays
• Scrub voucher (specific positions apply)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level