PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
At Bridgeport Hospital, we are committed to providing quality medical care and treatment that is coordinated and centered on the patient's specific needs. We strive to achieve benchmarks as a Patient Centered Medical Home and provide health care in a setting where patients are at the center of their care team. All employees of Bridgeport Hospital are part of the patients care team and contribute to the team approach of promoting access, continuous, comprehensive care and work to provide quality improvement in the care provided to their patients.
Manage the Human Research Protection Program and serves as the regulatory compliance analyst, educator and manager for all research related activities involving Bridgeport Hospital, Northeast Medical Group, Lawrence and Memorial Hospital and Bridgeport Anesthesia Associates.
1. Ensure that all entities covered by the Bridgeport Hospital IRB are accredited as required by Federal Regulations.
2. Ensure that all human subject research promotes the protection of the rights and welfare of human subjects and is in compliance with the Institution's Federalwide Assurance
3. Thoroughly review of all research protocols submitted for IRB approval. Determine status of protocol and provide expedited approval and exemption status when appropriate.
4. Develop and update policies and procedures, standard operating procedures, forms/templates, investigator manuals, as well as accurate IRB reports to submit to regulatory agencies and/or hospital committees.
5. Educate investigators and research staff about their ethical responsibility to protect research participants as well as the IRB application process.
6. Guide investigators in the development and submission of protocols.
7. Point person for the institution in unannounced FDA audits and instrumental in ensuring successful results.
8. Track industry sponsored clinical trial agreements to ensure the maximum recovery of IRB fees.
9. Manage the electronic protocol management system and current IRB database.
10. Ensure IRB website is up to date.
11. Ensure that items are properly prepared for IRB meetings, attend meetings, ensure that in-depth meeting minute are taken that serve as the official record of compliance with federal regulations and that meeting follow--up correspondence is completed in an accurate and timely fashion.
12. Develop and conduct a post--approval compliance monitoring program for each entity served by the Institutional Review Board.
Bachelor degree required.
With at least 3-5 years of experience working with in a clinical research administrative capacity. Excellent PC literate skills; previous database maintenance experience.
Certification as IRB Professional (CIP)
Full time; Days 8:00am-4:30pm
3-5 years of experience working in a clinical research administrative capacity preferred. Excellent PC literate skills and previous database maintenance experience. Strong communication and interpersonal skills, Demonstrated ability to work independently. Ability to interpret and apply federal rules and regulations regarding human research. Knowledge of Medical Terminology. Maintain certification as IRB Professional (CIP)
While performing the duties of this job, the employee is required to use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is required to stand and walk. The employee must frequently stoop, kneel, crouch, or crawl; talk or hear. The employee must regularly lift and/or move up to 25 pounds, occasionally move and/or lift up to 50 pounds. The specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. The noise level in the work environment is usually moderate. Incumbents as well as external and internal applicants who become disabled must be able to perform the essential job functions with or without the assistance of reasonable accommodation as determined on a case by case basis.
YNHHS Requisition ID
Internal Number: 27447
About Yale New Haven Health Bridgeport Hospital
We have an opening for an Institutional Board Administrator at Yale New Haven Health Bridgeport Hospital.