Quality and Regulatory Associate

Summary: 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.

Duties and Responsibilities

Quality Duties

• Responsible for quality control checks on study documents related to the conduct of the clinical trial in different therapeutic areas and phases
• Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements)
• Will also support training for site staff, this include creating and presenting quality content.
• Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services)
• Assist with writing QA audit or QC reports
• Works with internal clinical research team to ensure that inspection findings are clearly communicated and understood
• Evaluates inspection finding responses to ensure they are written to address the findings appropriately
• Ensures 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
• Identifies and communicates opportunities for process improvement based on audit and inspection observations
• Maintains necessary documentation of QA records and study files
• Notifies management of observed quality and compliance trends in the areas inspected
• Interprets GCP, and associated regulatory documents to facilitate auditing and process improvement recommendations
• Carries out appropriate self-development efforts as directed
• Performs other related duties as assigned

Regulatory Duties

• Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols
• Maintains subject and document confidentiality, understands, and complies 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
• Works under limited supervision to assure compliance with federal regulations relating to human subject research
• Understands and applies 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
• Prepares, maintains, and provides oversight to all research-related regulatory documents
• Populates and coordinates the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary
• Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor
• Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents
• Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records
• Prepares for monitoring visits and audits
• Manages and updates employee curriculum vitas and ensures copies of all current and applicable medical licenses are on file
• Creates error free written documents and reports such as cover letters, notes-to-file, and memos
• Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor
• Interacts 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 attends site initiation visits
• Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume
• Other duties as assigned

Duties, responsibilities, and activities may change, or new ones may be assigned at any time.

Qualifications

• Bachelor’s Degree in 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 regulatory and/or quality associate in clinical research
• Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred
• 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 the company's high standards and mission
• Comply with the company policies, code of ethics, and guiding values at all times

Competencies

• Strong analytical and problem-solving skills
• Detail oriented with the ability to perform at a high level of accuracy
• Proactive at 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

Work Environment and Physical demands

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Travel between two NJ sites is required
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasionally squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Salary and Benefits

Summit Clinical Research Solutions provides each of our team members with opportunities for personal and professional growth in a team-oriented working environment. We offer competitive pay, excellent benefits, and the chance to grow professionally in the healthcare industry. The salary range for this position will be commensurate with experience.

• 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)
• And more!

Summit Clinical Research Solutions is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.