CCTO Investigator Specialist
3 weeks ago
The Cancer Clinical Trials Office (CCTO) Investigator-Initiated Trial (IIT) Specialist is a critical role that requires a detail-oriented and organized professional to collaborate closely with investigators and the IIT Manager. This position provides operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer Center.
Key Responsibilities- Provide administrative oversight of IIT study progress, including drafting administrative sections of research protocols, case report forms, consent forms, and other study documents.
- Support investigators with FDA correspondence to ensure compliance with federal regulations for institutionally or Principal Investigator (PI)-held Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
- Create Institutional Review Board (IRB) submissions and manage correspondence across research sites, particularly in single-IRB/multi-site studies.
- Plan and implement changes to the research plan in collaboration with the PI and study team.
- Collaborate with investigators and biostatisticians to ensure data collection meets the objectives of the studies and to create clinical study reports as needed.
- Work with management to develop Standard Operating Procedures (SOPs), Work Instructions, and Forms.
- Coordinate operations, data collection, and research staff training at each protocol site.
- Assist investigators with protocol disclosures, such as those required for and the Clinical Trials Reporting Program.
- Identify and report unanticipated problems to the PI, study team, IRB, FDA, and Data Safety Monitoring Committee (DSMC), as applicable.
- Assist in the development of study budgets in collaboration with the IIT and Finance Managers.
- Collaborate with Quality Assurance programs during research audits and monitoring.
- Attend and actively participate in Clinical Research Team meetings.
- Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines, ensuring strict patient confidentiality as per HIPAA regulations and applicable law, and ensuring compliance with all federal and local agencies, including the FDA and local IRB.
- Bachelor of Science or other advanced healthcare degree
- At least 3 years of experience with clinical studies in a healthcare setting
- Knowledge and experience in regulatory guidelines and requirements for the conduct of clinical trials
- Proficiency in Microsoft Office applications
- Master's Degree or PhD in a related field
- Additional experience in clinical research, including medical writing
- ACRP/SOCRA certification (or equivalent)
- Experience with multi-site studies
- Familiarity with industry partners (e.g., pharmaceutical companies, CROs, central laboratories)
- Experience with IND/IDE submissions to the FDA
- Knowledge of policies and procedures governing clinical research and research subject protection, including US Federal Regulations, FDA guidelines, International Council for Harmonisation, Good Clinical Practices, HIPAA, NCI, and NIH regulatory and research disclosure requirements
-
Clinical Research Specialist
4 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Clinical Research Specialist will provide operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer Center. This role will collaborate closely with investigators and the IIT Manager to ensure compliance with federal regulations and institutional policies.Key ResponsibilitiesProvide...
-
Cash Management Specialist
3 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Cash Management Specialist will provide operational support within the Hospital's Cash Posting and Account Management Department. This role will support day-to-day business functions, including cash posting, payment processing, remittance follow-up and investigation, payment reconciliation, and financial reporting.Key ResponsibilitiesPreparing...
-
Clinical Research Specialist
4 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Clinical Research Specialist will provide operational support and regulatory management for investigator-initiated clinical research at Stony Brook Medicine. This role will contribute to the design, training, implementation, and regulatory compliance of research projects.Key ResponsibilitiesCreating and managing data collection forms and...
-
Cash Management Specialist
4 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Cash Management Specialist will provide operational support within the Hospital's Cash Posting and Account Management Department. The position will support day-to-day business functions including, but not limited to: cash posting, payment processing, remittance follow-up and investigation, payment reconciliation and financial reporting.Key...
-
Cash Management Specialist
4 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryStony Brook Medicine is seeking a highly skilled Cash Management Specialist to provide operational support within the Hospital's Cash Posting and Account Management Department. The successful candidate will be responsible for day-to-day business functions, including cash posting, payment processing, remittance follow-up and investigation, payment...
-
Cash Management Specialist
3 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Cash Management Specialist will provide operational support within the Hospital's Cash Posting and Account Management Department. This role will support day-to-day business functions, including cash posting, payment processing, remittance follow-up and investigation, payment reconciliation, and financial reporting.Key ResponsibilitiesPreparing...
-
Cardiovascular Perfusion Specialist
3 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob Summary:Stony Brook Medicine is seeking a skilled Cardiovascular Perfusion Specialist to join our team. As a key member of our cardiac surgery team, you will be responsible for operating a heart-lung machine while the surgeon performs heart surgery.Key Responsibilities:Manage the physiological and metabolic demands of patients during cardiac...
-
Travel Nurse RN
4 weeks ago
Stony Brook, New York, United States Cynet Health Full timeJob Title: Travel Nurse RN - Acute Care SpecialistJob Specialty: RN3: Level 3 RN PR1Job Duration: 13 weeksShift: 3x12-hour shifts, Nights, 7pm-7:30am, Every Other Weekend, 72 hours biweeklyGuaranteed Hours: [Not specified]Experience: Preferred: Travel RN Experience, Cerner Medical Record Experience; Required: 2 years of Nursing ExperienceLicense: Current RN...
-
Veterinary Medicine Specialist
3 weeks ago
Stony Brook, New York, United States Stony Brook University Full timeJob Summary:We are seeking a highly skilled Clinical Veterinarian to join our team at Stony Brook University. As a Clinical Veterinarian, you will be responsible for providing veterinary care for a wide variety of species of animals used in biomedical research programs. Your expertise will be essential in ensuring the health and well-being of these animals,...
-
Wound Care Nurse Assistant
4 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Wound Care Nurse Assistant is a vital member of the Long Island State Veterans Home's clinical team, working under the direction of the Wound Care Nurse to maintain residents' skin integrity. This role involves providing education to staff, residents, and families on skin integrity and wound/ostomy care protocols, policies, and procedures.Key...
-
Wound Care Nurse Assistant
3 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Wound Care Nurse Assistant is a vital member of the Long Island State Veterans Home's clinical team, working under the direction of the Wound Care Nurse to maintain residents' skin integrity.Key ResponsibilitiesImplement skin integrity and wound/ostomy care protocols in accordance with nursing standards, wound care society recommendations, and...
-
Pediatric Ophthalmology Specialist
3 weeks ago
Stony Brook, New York, United States Stony Brook University Full timeJob Summary:The Department of Ophthalmology at Stony Brook University is seeking a full-time Academic Pediatric Ophthalmologist to join our team. As a key member of our department, you will be responsible for providing inpatient and outpatient clinical care, educating residents and medical students, and engaging in research or scholarly...
-
Occupational Therapist
3 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob Summary:Stony Brook Medicine is seeking a skilled Occupational Therapist to join our Inpatient Occupational Therapy team. As a key member of our team, you will provide high-quality clinical services to our patient population, promoting independence and functional ability.Key Responsibilities:Develop and implement occupational therapy treatment programs...
-
Safety Specialist
4 weeks ago
Stony Point, New York, United States MSCCN Full timeJob Title: Safety SpecialistJob Summary/Purpose:We are seeking a highly skilled Safety Specialist to join our team at Entergy Arkansas. The successful candidate will be responsible for supporting Power Delivery Operations in the management of developing safety training programs, strategies, presentations, workshops, communications, and policies.Key...
-
Medical Imaging Specialist
3 weeks ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryWe are seeking a highly skilled and dedicated Radiology Technologist to join our team at Stony Brook Medicine. As a Radiology Technologist - CT Scanner, you will play a critical role in providing high-quality diagnostic imaging services to our patients.Key ResponsibilitiesProduces diagnostic exams, positions, and transfers patients, provides...
-
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewAs a Compliance Investigator, Clinical Manufacturing with Lynkx Staffing LLC, you will lead life-cycle investigations to improve processes by implementing corrective and preventative actions to ensure compliance. Your expertise will be crucial in determining the causes and preventative actions of deviations, non-conformances, and other issues....
-
Stony Brook, New York, United States Stony Brook University Full timeJob SummaryThe Stony Brook University Department of Surgery is seeking a highly skilled Physician Assistant/Nurse Practitioner to join our team as a Clinical Instructor. This is a non-tenure track position that will provide medical treatment plans for patients in a busy otolaryngology practice.ResponsibilitiesWork with physicians and nurses to provide...
-
Stony Brook, New York, United States Stony Brook University Full timeJob Summary:The Clinical Instructor of Surgery and Otolaryngology will work with physicians and nurses in the practice to provide medical treatment plans for patients. The candidate is expected to become an active member in the patient care team in a busy otolaryngology practice with specialized care of patients with head and neck disease including...
-
Stony Brook, New York, United States Stony Brook University Hospital Full timeJob SummaryThe Assistant Director of Infection Prevention and Control is a critical role at Stony Brook Medicine, reporting directly to the Director of Healthcare Infection Prevention and Control. This position is responsible for assisting in the execution of the hospital's infection prevention program, ensuring compliance with regulatory agencies, and...
-
Stony Brook, New York, United States Stony Brook University Full timeStony Brook University:Health Sciences:Renaissance School of Medicine: Psychiatry and Behavioral HealthStony Brook University is a leading academic medical center that is undergoing tremendous growth.Our adult outpatient psychiatry service is expanding, and we are seeking individuals who welcome the challenge and satisfaction of providing outpatient...
