- Mirum Pharmaceuticals (San Mateo, CA)
- … development is preferred. Demonstrated ability to analyze and interpret efficacy and safety data . Strong understanding of regulatory operational activities. ... Lead. Leads the preparation of regulatory documentation in support of Regulatory Authority Interactions (briefing books). Support the Clinical Operation Team… more
- Glycomine (Boston, MA)
- …who oversee the timely capture, reporting, and evaluation of adverse events and product safety issues. Oversee clinical and regulatory files, including the ... Oversight Plan, etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Translational Medicine and Program… more
- Parexel (Baltimore, MD)
- … data , and vital signs data , as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies. Ensures that all ... Parexel Early Phase Clinical Unit supports the development of innovative new...in the review of source data and/or data listings of safety data ,… more
- Mirador Therapeutics, Inc. (San Diego, CA)
- …and DMP. Knowledge of Good Data Management Practices (GDMP), Good Clinical Practice (GCP), ICH, and Regulatory requirements. Demonstrated ability to develop, ... San Diego, CA. Summary We seek a talented Director, Clinical Data Management (CDM) who will serve... study reports (CSR). Review Investigator Brochures (IBs) and Data Safety Update Reports (DSURs). Contributes to… more
- The University of Miami (Miami, FL)
- …integrity of clinical research documentation and protocol workflows. Identifies clinical safety implications during study development. 6. Supervises other ... evaluation. 11. Collaborates synchronization of study visits, procedures, and clinical tests with data collection schedules, established time-points;… more
- Dana-Farber Cancer Institute (Boston, MA)
- …and complying with clinical trial performance benchmarks; eg protocol and regulatory compliance, patient safety , staff development & training and financial ... to electronic regulatory binders. Will maintain per DFCI CTO standards. Data Management & Clinical Trial Monitoring Assumes responsibilities for data… more
- Beth Israel Lahey Health (Boston, MA)
- …violations and deviations to study protocols. Oversees reporting of AEs, SAEs, IND safety data , violations, deviations and submission of other study documents to ... in people's lives. The Regulatory Specialist supports regulatory compliance for clinical research at Beth...submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety … more
- Hackensack Meridian Health (Paramus, NJ)
- …assists with queries related to data to evaluate the significance of collected data . Provides education to all departments and clinical areas where study is ... to transform healthcare and serve as a leader of positive change. The Clinical Research Nurse is responsible for coordinating and overseeing clinical research… more
- Aditum Bio (Oakland, CA)
- …of concept. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to ... Portfolio Companies clinical trials. This includes the translation of preclinical data into clinical trial design and execution, clinical trial… more
- Pennsylvania Medicine (Woodbury Heights, NJ)
- …Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn ... employees shape our future each day. Are you living your life's work? Clinical Services Associate (Medical Assistant) Entity: (CCA) /Penn Primary Care (PPC) and Penn… more
- Cedars Sinai (Los Angeles, CA)
- …objectives. Responsible for completing case report forms, entering clinical research data , and assist with regulatory submissions to the IRB. Provides ... Administrator or Research Nurse to coordinate/implement study. *Evaluates and abstracts clinical research data from source documents. *Ensures compliance with… more
- Catholic Charities of Denver (Denver, CO)
- …the Catholic Charities Samaritan House and WES (Women Emergency Services) clinical functions, including regulatory , Medicaid/Medicare and Grant(s) oversight. The ... Applications are accepted on an ongoing basis until position is filled. Clinical Director- Denver Shelters (LCSW/LPC/LAC) OUR PURPOSE Catholic Charities of the… more
- NYULMC (New York, NY)
- …compliance, laboratory safety , and quality. Maintains relevant records consistent with regulatory standards. Data : Oversees data compilation for the ... maintains responsibility for developing, implementing, and maintaining Quality Assurance for Clinical Laboratory. Oversees regulatory compliance for Clinical … more
- Northwestern Memorial Healthcare (Chicago, IL)
- …to limit medication usage to formulary items when appropriate. Documents all clinical activities and interventions performed. Collects data , maintains logs, ... care of our employees. Ready to join our quest for better? Job Description The Clinical Pharmacist PNE reflects the mission, vision, and values of NM, adheres to the… more
- Pharmacy Careers (Fremont, CA)
- …reporting. Key Responsibilities: Analyze adverse event reports and clinical trial safety data . Prepare regulatory submissions (eg, MedWatch, PSURs). ... PharmD with strong understanding of pharmacology. Prior experience in drug safety or clinical data review is a plus. Detail-oriented with excellent… more
- LanceSoft (Lafayette, CO)
- …and procedures. Participates in 's quality management system and regulatory adherence. Performs procurement, packaging, labeling, distribution of tissue, supply, ... demonstrate knowledge of the training. Perform and work in a team environment Safety sensitive position with access to personal and health information of donors and… more
- Alura Workforce Solutions (Princeton, NJ)
- …use of Client medicines. Develop and update WW/US medical content per clinical development program, publications, data presentations, congress activity, MI ... Code of Conduct, and other guidance related to post-marketing practices and scientific data communication o Understanding of clinical trial design and execution,… more
- Carolina Digestive Health Associates (Monroe, NC)
- Job Type Full-time Description Summary: The Primary Clinical Assistant is responsible for assisting Physicians, Advanced Care Providers and Registered Nurses in the ... the delivery of high quality patient care and patient satisfaction. *Ensures the safety of patients at all times. *Promotes patient satisfaction by interacting with… more
- Wayne Health (Livonia, MI)
- …health and/or chemical dependency treatment, assessments, individual or group clinical services Coordinates patient referrals for substance abuse treatment, ... and work therapy as needed Provides accurate patient assessment; evaluates data ; develops individualized Plan of Care following guidelines for Person-Centered Plans… more
- Penn State University (Hershey, PA)
- …process for external applicants. JOB DESCRIPTION AND POSITION REQUIREMENTS: The Pediatric Clinical Research Office at the Penn State College of Medicine, Hershey, ... PA, is hiring a full-time Clinical Research Coordinator. The position supports clinical ...investigator-initiated studies. This position will also take part in data collection, data entry into appropriate databases,… more
