What are the responsibilities and job description for the Regulatory Associate position at Pinnacle Clinical Research, LLC?
Who We Are:
Pinnacle Clinical Research (PCR)/ South Texas Research Institute (STRI) is a private, physician-led clinical research site. With a current focus on non-alcoholic fatty liver disease, fibrosis, and cirrhosis, PCR/STRI offers comprehensive liver care for clinical trial participants. We are committed to the advancement of science through our partnerships and work in drug development. To learn more about STRI, go to www.southtexasresearchinstitute.com
Pinnacle Clinical Research (PCR)/ South Texas Research Institute (STRI) is a private, physician-led clinical research site. With a current focus on non-alcoholic fatty liver disease, fibrosis, and cirrhosis, PCR/STRI offers comprehensive liver care for clinical trial participants. We are committed to the advancement of science through our partnerships and work in drug development. To learn more about STRI, go to www.southtexasresearchinstitute.com
The Opportunity:
The Regulatory Associate support the clinical research trials for the site and be primarily responsible for ensuring timely and accurate submission of regulatory and IRB documents for new and ongoing studies. They will be responsible for ensuring site is adhering to all applicable regulatory regulations for the conduct of clinical research and providing regulatory guidance to clinical operations team.
The 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 supervision of a mentor/coach, the Regulatory Associate will be responsible for:
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 as a clinical research coordinator, clinical research assistant or regulatory associate for therapeutic clinical trials
- Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred
- Previous experience with IRB submissions and requirements
- 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/STRI’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
FLSA Classification: This is a non-exempt position.
Salary and Benefits:
South Texas Research Institute 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.
Other benefits of the Clinical Research Data Coordinator role include:
- Medical, Dental, and Vision Insurance
- Life Insurance
- Short Term Disability
- Long Term Disability
- Generous Paid Time Off policy
- 401(k) Retirement Plan with company match
South Texas Research Institute is an equal opportunity employer, committed to inclusive hiring, and dedicated to diversity in our work and staff. We strongly encourage people from all groups and communities to apply.
Salary : $55,500 - $70,200