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Senior Regulatory Compliance Specialist
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Responsible Conduct Research Analyst
3 months ago
At Houston Methodist, the Responsible Conduct of Research (RCR) Analyst position is responsible for providing regulatory compliance support and education to the research community in all RCR areas including, but not limited to: Conflict of Interest, Data Acquisition, Management and Sharing, Research Misconduct, Collaborative Research, Authorship/Publication, Human and Animal Subjects (in collaboration with the IRB/IACUC), Peer Review, Mentorship, and Scientist as Responsible Member of Society (rigor and reproducibility). This position includes providing administrative support for and provision of RCR training programs for faculty, staff, and trainees, the provision of assistance to research personnel for software programs designed to review research results, and working closely with RCR team members to ensure that the highest ethical standards are incorporated in research designed, conducted, or reported by Houston Methodist. The RCR Analyst position supports routine analyses of RCR implementation and quality improvement efforts in multiple areas across the research enterprise and may also provide support in the review of laboratory or clinical data and management of individual and institutional conflicts of interest.
Additional Information:
priority given to those applicants who have prior work experience with the grant submission process. In addition, prior experience with reviewing lab notebooks, and sequestration of data for research misconduct cases.
PEOPLE ESSENTIAL FUNCTIONS
- In collaboration with Sr. RCR Analysts and Research Integrity and Compliance (RIC) leadership, advises and provides input to team members and stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes related to the Responsible Conduct of Research.
- Organizes/provides Responsible Conduct of Research (RCR) educational workshops for individuals engaged in research at the institution, including faculty, staff, and trainees.
- Conducts self in a manner that is congruent with cultural diversity, equity and inclusion principles. Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.
SERVICE ESSENTIAL FUNCTIONS
- Provides administrative support to the Manager, Responsible Conduct of Research, and Sr RCR Analysts as needed to ensure institutional knowledge of key educational and compliance efforts.
- Provides consultation and guidance to research teams and departments on an ongoing basis. Communicates with related regulatory committees and administrative departments to ensure RCR requirements are met.
- Participates in targeted Houston Methodist RCR research quality efforts upon request
QUALITY/SAFETY ESSENTIAL FUNCTIONS
- Consistently evaluates process and workflow to ensure efficiency and compliance in the facilitation of research across the health system and communicates effectively with ORP leadership any gaps or areas for improvement.
- Participates in administrative processes in support of RCR training and Conflict of Interest (COI) review. Conducts thorough and complete regulatory review of applicable regulatory requirements to assure completeness, consistency, accuracy, and tracking of RCR plans.
- Assists in ensuring federally-required research misconduct, RCR, and COI processes and reporting are carried out to minimize risk to the institution as needed
FINANCE ESSENTIAL FUNCTIONS
- Utilizes resources with cost-effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
- Identifies areas of the review process that require improvement, or that could be made more efficient and effective. Works with the electronic submission team to resolve problems, suggest improvements and test programming upgrades.
- Assists leadership and research auditors in assessing processes in RCR areas.
- Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
EDUCATION
- Bachelor's degree
WORK EXPERIENCE
- Three years of related work experience
LICENSES AND CERTIFICATIONS - REQUIRED
- N/A
KNOWLEDGE, SKILLS, AND ABILITIES
- Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
- Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially concerning activities impacting patient or employee safety or security
- Ability to effectively communicate with research team members and co-workers in a manner consistent with a customer service focus and application of positive language principles
- Strong project management skills
- Ability to initiate and complete tasks with minimal supervision
- Ability to deal with high volumes and rigid deadlines
- Ability to maintain effective interpersonal relationships
- Ability to rapidly acquire and implement knowledge of related regulations and ethical principles
- Exercises independent judgment related to situations of a sensitive, confidential, and scientific nature
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
- Uniform No
- Scrubs No
- Business professional Yes
- Other (department approved) No
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
- On Call* No
TRAVEL**
**Travel specifications may vary by department**
- May require travel within the Houston Metropolitan area Yes
- May require travel outside Houston Metropolitan area Yes
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.
Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.
Equal Employment Opportunity
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.