- MVP Health Care (Tarrytown, NY)
- …of professional investigation experience involving economic or insurance relatedmatters. + A clinical investigator must have in addition to the above ... Cognos, CMS web sites, and Encoder-Pro. **Your key responsibilities:** + Conduct clinical reviews of various forms of medical documentation and records obtained from… more
- Mount Sinai Health System (New York, NY)
- …The **Project Manager II** will oversee the entire portfolio of Investigator -Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration ... in clinical research, including at least 2 years managing investigator -initiated trials preferred. + Proven track record in regulatory compliance, project… more
- Sanofi Group (Morristown, NJ)
- …requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA...turn the impossible into possible for millions. The Senior Clinical Research Director (CRD) is an **expert clinical… more
- Organon & Co. (Jersey City, NJ)
- …medicine and clinical pharmacology components of TMED study protocols, clinical study reports, Investigator Brochures, briefing books, IND subsections, ... translational medicine and clinical pharmacology components of study protocols, clinical study reports, Investigator Brochures, briefing books and other… more
- Mount Sinai Health System (New York, NY)
- …clinical trials. + Obtains informed consent under supervision of the Principal Investigator , Clinical Research Manager, or Senior Clinical Research ... **Job Description** Under minimal supervision, coordinates the clinical assessments of the study subjects; analyzes and...subject data through chart reviews. + Assists the Principal Investigator and regulatory staff in the preparation of new… more
- Mount Sinai Health System (New York, NY)
- …and family members who have concerns and escalates to Principal Investigator /Sub- Investigator , Clinical Nurse Manager/Assistant Nurse Manager/Nursing Shift ... **Job Description** The Clinical Research Nurse is a Registered Professional Nurse...and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges.… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …adverse events (SAEs), and emerging safety signals. + Review documents supporting clinical development such as Investigator 's brochure, regulatory documents for ... Clinical Study Physician Date: Jan 1, 2026 Location:...and interim cuts. Supports site selection, patient recruitment, and investigator engagement through regular interactions and guidance. + Leads… more
- Mount Sinai Health System (New York, NY)
- …in clinical research studies under the supervision of the Principal Investigator or senior clinical research staff. This individual obtains informed consent, ... matter of the research project, under direct supervision of the Principal Investigator or senior clinical research staff. + Assists in the activities related to … more
- Pfizer (New York, NY)
- …documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, ... relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and… more
- Sanofi Group (Morristown, NJ)
- …docs and supports registration, labelling etc + Develop and/or contribute in the clinical section of the Investigator 's brochure, CTA, IND, DSUR, DRMP, RMP ... **Job Title:** Senior Clinical Research Director **Location:** Cambridge, MA or Morristown,...the elaboration of training material and presentations at the investigator meetings/local teams trainings + Answer to medical questions… more
- IQVIA (Parsippany, NJ)
- …sponsor point of contact, global cross functional business partners + **Others:** Clinical Investigator Sites, Commercial Suppliers, Clinical Trial Insurance ... Overview** Join a team that's shaping the future of clinical research! We are seeking a **Global Program Analyst**...Program Analyst** to support critical services that enable successful clinical trials worldwide. In this role, you will manage… more
- AbbVie (Florham Park, NJ)
- …design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and ... Description With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development… more
- Mount Sinai Health System (New York, NY)
- …of hematology/oncology Principal Investigators and researchers with development of investigator -initiated clinical trial protocols. Must understand complex ... obtains approval from the Food and Drug Administration (FDA) for investigator -initiated clinical trials. Acts as primary contact for all FDA communication,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents ( Investigator Brochures, protocols, clinical study reports, ... drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS;… more
- Sanofi Group (Morristown, NJ)
- …forms, clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory ... **Job Title:** Clinical Lead, Early Clinical and Experimental...and correctly conducted. + Prepare and review the interim investigator reports. + Lead the Dose Escalation Meeting and… more
- TKL Research, Inc. (Fair Lawn, NJ)
- …provide medical and scientific leadership within the development, execution, and reporting of clinical trials. This position will support our clinical teams to ... provide proper safety, medical, and scientific oversight on all clinical activities. Responsibilities include evaluating and monitoring study volunteers, participate… more
- Sanofi Group (Morristown, NJ)
- …to regulatory and safety documents and meetings:** + Review and/or contribute in the clinical section of the Investigator 's brochure, CTA, IND, DSUR, DRMP, RMP + ... DSD is to: + Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project...the elaboration of training material and presentations at the investigator meetings/local teams trainings + Answer to medical questions… more
- Mount Sinai Health System (Queens, NY)
- …diverse community and we welcome candidates who are interested in being an investigator in clinical trials for cooperative group studies, pharmaceutical studies ... full support of our knowledgeable research staff for both regulatory and clinical needs. There are experienced physician assistants within the urology department who… more
- Hackensack Meridian Health (Hackensack, NJ)
- …out the research and works under the general supervision of the principal investigator responsible for the clinical trials. Education, Knowledge, Skills and ... and serve as a leader of positive change. The ** Clinical Research Nurse** is responsible for coordinating and overseeing... Research Nurse** is responsible for coordinating and overseeing clinical operations of a clinical trial and… more
- Hackensack Meridian Health (Hackensack, NJ)
- …carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials. + BSN required. (Note: this ... and serve as a leader of positive change. The ** Clinical Research Nurse** is responsible for coordinating and overseeing... Research Nurse** is responsible for coordinating and overseeing clinical research operations for all assigned clinical … more