Research Compliance Job Description
Research compliance
provides education and direction regarding the fundamentals of human subject research, Intermountain IRB/Research policies, procedures, and guidelines, and federal and state regulations.
Research Compliance Duties & Responsibilities
To write an effective research compliance job description, begin by listing detailed duties, responsibilities and expectations. We have included research compliance job description templates that you can modify and use.
Sample responsibilities for this position include:
Develop, implement, and manage efficient procedures to facilitate the processing of reliance agreements and single IRB (sIRB) reviews, in accordance with Stanford, federal, and state policies and procedures
Apply knowledge of federal, state, and local regulations, university policies and practices, to ensure compliance with IRB Reliance Agreements
Evaluate and implement the compliance program (i.e., policies, procedures, training, systems and controls, reviews, ) for CS' Equity and Fixed Income Research Departments, which includes formulating and implementing requirements applicable to changing regulatory requirements and the supervision of those businesses
Managing Federal and State income tax audits
Participate in the cross training of college-based HRPP Coordinators on policies and procedures regarding HRPP/IRB review of human subject research
In collaboration with the other members of the research compliance team, perform analysis of and ensure adequate and timely review of protocol violations, unanticipated events and allegations of non-compliance with applicable regulations and policies brought to the HRPP’s attention
Understand, assess and advise on issues such as research independence, potential conflicts of interest arising from IBD, Sales & Trading and other interactions with Research, what constitutes research (i.e., market commentary vs
Provides professional expertise, guidance and strong leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements
Develop and integrate process improvements utilizing technology
Conduct self-monitoring of Research and Due Diligence written supervisory procedures (WSPs) and ensure maintenance of supporting documentation
Research Compliance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Research Compliance
List any licenses or certifications required by the position: CAMS, ACRP, ICD, CPC, ACAMS, CPIA, HCPCS, DRG, CPT, CPA
Education for Research Compliance
Typically a job would require a certain level of education.
Employers hiring for the research compliance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Health, Biological Sciences, Management, Business, Healthcare, Law, Social Sciences, Science, Administration
Skills for Research Compliance
Desired skills for research compliance include:
Policies
Quantitative and qualitative research design
Relevant Federal and State regulations
Research compliance as it relates to human subject research and IRB functions
State
Applicable regulations and government
Industry and company GCP standards by participating in industry trainings
Scientific and medical concepts and terminology
Scientific research concepts and terminology
Standard office software
Desired experience for research compliance includes:
Interfacing with the Accounting Group and other data providers
Interfacing with and advise internal stakeholders
Calculating foreign source income and foreign tax credits
Supervising the preparation of current and deferred income tax provisions
Supervising professional staff in respect of research and tax planning matters, including preparation and review of research product and related memoranda
Provide support to Compliance Audit, Legal, and Financial Intelligence Unit on compliance matters
Research Compliance Examples
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Research Compliance Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of research compliance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for research compliance
- Routine reviews may include compliance with regulatory requirements of the Sponsor Trial Master Files, FDA correspondences, sponsor oversight or the project, Investigator compliance with the protocol and institutional policies and procedures
- Continuously identify regulatory trends and developments, advising business staff as to how this may impact their current activities, and working with supervisors to implement any required changes to current policy / practice
- Assist in the preparation of Compliance reports for Compliance Management, Senior Management, Executive Committees, and Risk Committees
- Create, monitoring, and manage TA’s social media
- Taking an active role in in planning and implementation events related to the TA
- Acts as point-of-contact for incoming support requests and questions from possible TA “clients” and collaborators, maintaining and high standard of excellence
- Exercise prompt and detailed communication back to the clients on status of tasks, ensuring deadlines and budgets are met
- Under the general direction of the HRPP Associate Director for Program Development, the Sr
- Serve as the primary point of contact and expert liaison for IRB Reliance Agreements and single IRB (sIRB) review
- Develop and implement training/educational materials for researchers and HRPP
Qualifications for research compliance
- Excellent writing skills required, including the ability to write for different audiences and in different voices
- Demonstrated ability to work on multiple tasks simultaneously, in a fast-paced, complex work environment, with a diverse population of administrators and faculty
- Must be able to establish goals, set priorities, and regularly produce high-quality work with minimal supervision
- Outstanding interpersonal and communication skills, including the ability to initiate, coordinate, and lead meetings with senior Hospital leadership
- Willingness and ability to undertake tasks from clerical work to strategic planning and everything in between
- Lead special projects or meetings and participate in multi-functional teams
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Research Compliance Job Description
Job Description Example
Our growing company is hiring for a research compliance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for research compliance
- Use independent judgment to, interpret, analyze and apply federal, state and local regulations, along with University rules and regulations, to insure that ethical research practices are followed
- Work closely with Information Management Systems & Services (IMSS), define the functionality necessary to implement protocol management software for the Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC)
- Assist with successful migration of the IRB protocol management software to a new platform
- Assist with integration and testing of the new protocol management software prior to launch
- Responsible for developing and implementing daily operational procedures for the efficient review of research proposals involving the participation of human subjects
- Conduct preliminary review of submissions requiring review by a convened IRB
- Provide regulatory, policy and administrative guidance to IRB members, researchers and college-based HRPP Coordinators
- Compose detailed and highly complex correspondence that adequately reflect all IRB concerns, provide the rationale for their concerns, and provide regulatory and ethical education, in a concise and intelligible manner
- Identify and recruit external consultants, auditors, and other experts as required by the IRB, and maintain effective communications with all third parties
- Oversee IRB meeting schedules to ensure the presence of a quorum
Qualifications for research compliance
- Comprehensive knowledge of regulatory information regarding the use of human participation in research and teaching
- Demonstrated understanding of the principles of human research protection standards
- Familiarity with grants and contracts functions
- Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management
- Advanced knowledge of human subjects protection regulations and best practices
- Knowledge of medical/scientific areas, such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, and epidemiology
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Research Compliance Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of research compliance. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for research compliance
- Responsible for maintaining up-to-date information regarding federal regulations, ethical consideration, and IRB policies related to the use of human participants in research
- Oversee the creation of complex meeting minutes, which include detailed description of IRB deliberations, outline of controverted issues and their resolution, and the justifications and ethical principles analyzed and reviewed by the IRB
- In collaboration with the other members of the research compliance team, receive, document and ensure adequate review of investigator, staff and subject complaints regarding the conduct of human subjects research
- Maintain the IRB database
- Conduct targeted risk assessments and develop comprehensive corrective action plans or remedial measures to address identified areas of concern
- Serve as an ex-officio member of university research compliance committees
- Determine the appropriate level of qualification and validation necessary for electronic systems to ensure compliance with relevant regulations and industry guidance documents
- Provide hands-on support to ensure the completion of computer system validation and the associated documentation
- Responsible for tracking key dates of planting, pollination, harvest, and post-harvest field management steps for multiple fields of different crops, for visiting each field to monitor plant emergence, development, and health at specified periodic intervals, and for keeping accurate and complete records of visits
- Participates in field inspections and takes detailed notes from the inspections
Qualifications for research compliance
- Direct IRB experience with an accredited institution preferred
- Occasionally stand, walk, and write by hand, lift, carry, push pull objects that weigh up to 10 pounds
- University degree (or equivalent), preferably in Law or Science
- At least 12 years of relevant professional experience including a minimum 5 years in the life sciences industry and 5 years in healthcare compliance
- Experience working in USA, Europe and Asia preferred
- Experience in a regional role and in dealing with diverse teams
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Research Compliance Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of research compliance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for research compliance
- Serves as a backup for irrigation, IPM, land preparation, and land planning
- Responsible for following supervisor’s instructions and protocols, taking notes and recording data, participating in process improvement plans and initiatives, and reporting to supervisors in a timely manner
- Assists in other tasks, not listed in this job description, assigned by supervisors
- Throughout employment, employees are selected to be project leaders at the location and as part of the daily work
- Participates in improvement programs (safety, efficiency, effectiveness) specific to lab, field, or greenhouse environments to identify and communicate potential risks and benefits
- Provides support for all other projects at the location as needed
- Job description may change at any time
- Serve as liaison for designated research protocols/studies
- Act as a resource for Board/Committee members regarding regulations during research protocol review
- Coordinate information to meet protocol reporting requir4ements
Qualifications for research compliance
- Able to build strong relationships with key stakeholders at all levels of the organization and across multiple geographies
- Fluent written and spoken English (other languages highly desirable)
- Solid understanding of healthcare laws, regulations and regulatory requirements pertaining to the pharmaceutical industry
- Knowledge of key Compliance concepts and their application to the pharmaceutical industry, particularly as relates to pharmaceutical research and development activities
- Collaborative and inclusive solution-oriented mindset
- Solid business acumen (commercial experience an advantage)
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Research Compliance Job Description
Job Description Example
Our innovative and growing company is hiring for a research compliance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for research compliance
- Resolve non-routine issues involving research protocols including direct communication with investigators and research staff
- Assist in the development and maintenance of daily operational policy and procedures
- Interact with investigators, faculty, students and administration of all levels
- Provide training and mentoring as needed, may conduct on-site audits
- May serve as full member on review board
- Application submission – consults with and advises investigators on the application submission process
- Ensure that standards for good clinical practice guidelines and governmental regulations are followed to achieve the highest quality regulatory management of the Center’s clinical research portfolio at collaborative sites (Alliance and Strategic partners, Multi-center sites, NCTN)
- Serve as primary inter-institutional liaison to the site’s research administration
- Oversee collaboration with the site’s leadership on all aspects of Clinical Trial Site participation
- Collaborate with the Institutional NCTN U10 Principal Investigator and Institutional Physician leaders to ensure full compliance with program goals and grant requirement/targets
Qualifications for research compliance
- Take a lead role in the development, improvement and implementation of QC laboratory systems for Client’s growing QC organization
- Implement controlled (issued and reconciled) worksheets and logbooks
- Author, review, and facilitate the approval of Standard Operating Procedures
- Take a lead role in Prior Approval Inspection (PAI)
- Broad knowledge of protein and peptide chemistry, biochemistry, and practical experience in testing (ELISA, Cell Culture, Thermo plate reader, PCR, and Bioanalytical assays)
- Experience with 5S is preferred