| Position Description |
Cold Spring Harbor Laboratory (CSHL), a world-renowned biomedical research facility on Long Island’s North Shore in New York, is searching for a Senior Research Compliance IRB Specialist. This position will support CSHL’s Institutional Review Board (IRB) and other institutional activities related to the protection of human subjects in biomedical research, in accordance with federal, state and local regulatory requirements/guidelines. In addition, the Research Compliance Specialist will support the Institutional Biosafety Committee (IBC), which oversees regulatory activities required for research using recombinant DNA and other potentially hazardous biological materials. The Research Compliance Specialist will report to the Director of Research Compliance and take part in all aspects of implementation and oversight of compliance, including training postdoctoral fellows and graduate students and ensuring research proposed in grant submissions fulfill compliance requirements.
Essential Duties and Responsibilities:
- Responsible for detailed institutional review of all research involving human subjects and/or recombinant DNA (rDNA).
- Document submission-specific findings and advise as to whether the requirements for IRB approval have been met.
- Responsible for reviewing and making determinations on IRB research studies.
- Evaluate researchers’ responses to IRB requests and generate notifications to researchers regarding the outcome of the review.
- Maintain and further develop personal knowledge about applicable statutes, policies and procedures governing human subject and rDNA research and related ethical codes and guidelines; interpret and apply these requirements to IRB/IC submissions and ongoing research activities.
- Serve as a voting member of the IRB and IBC.
- Assist with developing and drafting policy guidance and revisions.
- Manage pre-, intra- and post-meeting activities in partnership with the respective IRB Chair and review committees when applicable; provide technical support and guidance on regulatory matters during convened IRB meetings.
- Reviews and updates patient consent forms according to federal regulations.
- Participate in OHRP-led, as well as self-motivated, continuing education initiatives.
- Develop educational programs and materials for ethics and Responsible Conduct in Research training.
- Apply strong organizational skills and effective teamwork skills to assist in management of a large volume of submissions, deadlines, and inquiries.
- Keeps abreast of federal regulations, including FDA requirements.
- Responsible for developing and maintaining the Research Compliance website.
- Liaises with the CSHL Manager of Clinical & Translational Research and Northwell Health to coordinate affiliation projects.
- Train new lab members on how to use IRBNet electronic review system and facilitate onboarding.
- Develop positive relationships with researchers and colleagues throughout CSHL to facilitate compliance and greater efficiency of processes.
- Other work as assigned.
Core competencies necessary for success:
- Other work as assigned.
- Assimilates and applies job-related information; puts new knowledge, understanding, or skill to practical use on the job.
- Stays focused on work tasks and productively uses time, energy and resources to ensure that work is completed efficiently.
- Presents a positive disposition and maintains constructive interpersonal relationships.
- Makes researchers senior administrative staff and their needs a primary focus of one’s actions; develops and sustains productive relationships.
- Works effectively and cooperatively with others; establishing and maintaining good working relationships.
- Takes prompt action to accomplish objectives and to achieve goals beyond what is required; is proactive.
- Clearly conveys information and in a manner that engages the audience and helps them understand and retain the message.
- Assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed
|
| Position Requirements |
EDUCATION:
PhD Degree or Masters in Science
EXPERIENCE:
3-5 years experience in a basic research or biomedical setting with direct IRB and/or research experience.
The successful candidate will demonstrate:
- A strong interest in current biomedical research and experience in basic molecular biology techniques.
- Knowledge of the federal regulations for research using human subjects and recombinant DNA (rDNA) technology, bioethics, animal use, and HIPAA
- Excellent organizational and time management skills, the ability to multitask, meet deadlines, and problem-solve while maintaining a high degree of accuracy and attention to detail.
- Strong decision-making skills and demonstrated ability to assess analytically multiple issues in a variety of complex situations and research protocols.
- Excellent interpersonal and strong communication skills; ability to make accurate and appropriate independent judgments.
- Self-motivation to function both independently and collaboratively in a high intensity environment in a positive and effective manner.
- Experience and/or certification as an IRB professional
- Solid computer skills and strong competency in Microsoft Office products
- Experience with electronic administration systems
Our employees are compensated from a total rewards perspective in many ways for their contributions to our mission, including competitive pay, exceptional health benefits, retirement plans, time off, and wellness programs. Visit our CSHL Benefits site to learn more.
Candidates from non-traditional and/or underrepresented backgrounds, broadly defined, are strongly encouraged to apply.
For immediate consideration, please apply online to https://cshl.peopleadmin.com/postings/19970
Position 01758-A
Founded in 1890, CSHL has helped shape contemporary biomedical research and education with today’s research endeavors encompassing cancer, neuroscience, plant biology and quantitative biology. CSHL is a private, not-for-profit institution in New York and has been home to eight Nobel Prize winners. Today, CSHL’s multidisciplinary scientific community is bolstered by more than 600 researchers and its Scientific Meetings & Courses Program, which hosts more than 9,000 scientists from around the world each year on its campus. For more information about CSHL, please visit us at https://www.cshl.edu
You are required to be fully vaccinated for COVID-19 as a condition to your employment at the Laboratory. You will be required to provide proof of your vaccination on your first day of employment. For those individuals, who are unable to receive a vaccine due to access issues, they will be expected to receive the vaccine upon arrival in New York.
CSHL is an EO/AA Employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status. VEVRAA Federal Contractor |
