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
Regulator y 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
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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 PCR’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 Pinnacle Clinical Research 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
14 paid company holidays
Scrub voucher (specific positions apply)
And more!
Summit Pinnacle Clinical Research 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.
About Summit Pinnacle Clinical Research
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