Senior Research Compliance Analyst

Senior Research Compliance Analyst

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title:
Senior Research Compliance Analyst (RCA) 

Location: United States (Remote)

Function: The Senior RCA supports the institution’s Human Research Protection Program by providing expert-level regulatory review of human subjects’ research, managing IRB operations, and leading Data and Safety Monitoring Board (DSMB) activities. This role ensures compliance with federal regulations and institutional policies, facilitates IRB and DSMB meetings, and oversees safety monitoring processes for high-risk and clinical studies. The analyst conducts compliance audits, monitors risk and develops corrective action plans when necessary. Additionally, they provide education and training to researchers and staff and support strategic initiatives that promote ethical research practices and continuous quality improvement.      

DESCRIPTION:

The Senior RCA is a key member of the Human Research Protection Program (HRPP) and is critical in ensuring institutional compliance with federal regulations, institutional policies, and ethical standards governing human subjects research. The Senior RCA provides regulatory and ethical review of research protocols, manages DSMB operations, ensures robust human subject protections, and liaises investigators, the IRB, DSMBs, and institutional leadership.

 ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conduct regulatory and administrative reviews of research protocols submitted to the IRB to ensure compliance with 45 CFR 46, 21 CFR Parts 50 and 56, ICH GCP, and applicable institutional policies.
• Serve as the primary reviewer for complex biomedical and social-behavioral studies, including high-risk and multi-site clinical trials.
• Guide investigators through the submission, modification, and continuing review processes, providing expert advice on regulatory and ethical requirements.
• Interpret and apply federal, state, and institutional regulations to protect human subjects.
• Prepare detailed reviewer comments and recommendations for IRB meetings; serves as an IRB meeting facilitator.
• Establish DSMBs for applicable studies, including identifying and coordinating with internal and external board members with relevant expertise.
• Develop DSMB charters and data monitoring plans with principal investigators and sponsors.
• Coordinate and lead DSMB meetings, ensuring timely distribution of agendas, reports, and follow-up actions.
• Ensure DSMB decisions and recommendations are properly documented and communicated to relevant stakeholders, including the IRB and investigators.
• Work with study teams and sponsors to ensure data integrity, participant safety, and regulatory compliance.
• Educate and train investigators, research coordinators, and institutional staff on IRB processes, human subjects protections, and DSMB best practices.
• Participate in developing educational materials, guidance tools, and workshops to enhance institutional compliance.

·       Recommend process improvements to enhance the efficiency and effectiveness of HRPP and DSMB functions.

·       Expected to assist in preparing Institutional Biosafety Committee (IBC), Stem Cell Research Oversight Committee (SCRO), and Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes, and other related duties as required.

EDUCATION AND EXPERIENCE REQUIRED:

·       Bachelor’s degree or combination of education and relevant experience; master's preferred.

·       Minimum 5 – 7 years of progressive experience in human research protections, IRB administration, or compliance.

·       Deep understanding of federal regulations governing human subjects research (e.g., Common Rule, FDA regulations).

·       Experience coordinating or serving on DSMBs, DMCs, or similar data safety oversight bodies.

·       Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), Certified in Healthcare Research Compliance (CHRC) or equivalent credential strongly preferred. If not certified, must be able to obtain certification within the first year of employment.

·       Exceptional analytical, organizational, and interpersonal skills.

·       Strong written and verbal communication skills.

·       Ability to manage multiple priorities in a fast-paced environment with minimal supervision.

·       Proficiency with IRB electronic systems (e.g., Sitero Mentor Compliance) and data management platforms.

PREFERRED SKILLS:

·       Proficient with Microsoft Office Suite or related software. 

·       Experience with international research and knowledge of GDPR, ICH-GCP, or other international human subjects protections standards.

·       Experience working in an academic medical center, research institute, Central IRB, or with NIH-funded clinical trials.

·       Familiarity with risk-based monitoring and centralized DSMB operations across a research portfolio.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

·       Standard Hours 40 hours per week, one hour lunch, Monday – Friday.   Additional hours as needed.

·       Willing to work in shifts as and when needed.

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.