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: Colorectal Oncologist Consultant
Location: Remote
Function: Research Compliance
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The Research Compliance Committee Member serves as a subject-matter contributor responsible for reviewing research protocols, monitoring regulatory compliance, and ensuring protection of research participants, animals, data integrity, and biosafety standards. The role supports ethical, scientific, and regulatory oversight across multiple institutional review and monitoring committees. Members are expected to apply regulatory knowledge, professional judgment, and independence to ensure institutional and federal compliance standards are met.
Core Responsibilities (Applicable to All Committees):
- Review research submissions for regulatory, ethical, and institutional compliance.
- Prepare for and actively participate in scheduled meetings.
- Evaluate risks, benefits, and safeguards within research protocols.
- Identify non-compliance, protocol deviations, or safety concerns.
- Maintain confidentiality of sensitive research information.
- Provide recommendations for approval, modification, suspension, or termination of studies.
- Document reviews and determinations in accordance with institutional policies.
- Remain current with applicable regulations, guidance, and best practices.
- Complete required training and conflict-of-interest disclosures.
Committee-Specific Duties:
Institutional Review Board (IRB):
- Review human subjects research protocols, amendments, continuing reviews, and reportable events.
- Evaluate informed consent processes and participant protections.
- Assess risk/benefit ratios and subject selection equity.
- Ensure compliance with federal regulations, ethical principles, and institutional policies.
- Review privacy, confidentiality, and data protection measures.
- Participate in convened meetings and expedited reviews when assigned.
- Recommend safeguards for vulnerable populations
Institutional Biosafety Committee (IBC):
- Review research involving recombinant or synthetic nucleic acids, biohazards, and infectious agents.
- Assess containment levels, laboratory safety procedures, and personnel protections.
- Ensure adherence to biosafety regulations and institutional biosafety manuals.
- Evaluate incident reports and corrective actions.
- Recommend risk mitigation strategies for hazardous biological work.
Institutional Animal Care and Use Committee (IACUC):
- Review animal research protocols, modifications, and continuing reviews.
- Evaluate justification for animal use and species selection.
- Assess pain minimization, humane endpoints, and veterinary oversight.
- Review housing, husbandry, and procedural standards.
- Participate in semiannual facility inspections and program reviews.
- Ensure compliance with animal welfare regulations and ethical standards.
Data Safety Monitoring Board / Data Monitoring Committee (DSMB/DMC):
- Review interim study data for participant safety and data integrity.
- Assess adverse events, trends, and stopping rules.
- Recommend continuation, modification, or termination of trials.
- Maintain independence from study sponsors and investigators.
- Evaluate statistical analyses and safety monitoring plans.
- Ensure confidentiality of interim data and deliberations.
Stem Cell Research Oversight Committee (SCRO):
- Review research involving human stem cells, embryos, or pluripotent cell lines.
- Evaluate ethical sourcing, consent documentation, and derivation methods.
- Assess compliance with applicable laws, guidelines, and institutional policies.
- Determine permissibility of proposed stem cell activities.
- Monitor ongoing approved research for continued compliance.
- Address ethical concerns related to emerging technologies.
EDUCATION REQUIRED:
- MD degree and extensive experience within the Colorectal Oncology therapeutic area.
EXPERIENCE REQUIRED:
- Demonstrated knowledge of research regulations and ethical principles.
- Prior service on compliance or oversight committees.
- Regulatory or clinical research experience.
- Training in human subjects protection, animal welfare, biosafety, or data monitoring
COMPENSATION & BENEFITS:
Hourly Contractor Rate commensurate with experience
EMPLOYMENT TYPE:
Contractor
COMMITMENTS:
- Attendance at scheduled meetings (frequency varies by committee).
- Independent review time prior to meetings.
- Participation in ad hoc reviews or urgent matters 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.
