NewPrincipal Investigator (Gastroenterology) Professional Case ManagementPrincipal Investigator (Gastroenterology)Garden City, MI$156,600–$266,700 / yearRisks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result; Selection of human subjects and patients for research participation is equitable; Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by company policies and federal regulations; Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by company policies and federal regulations; Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects; The privacy of human research subjects is protected and the confidentiality of data is maintained; Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons). Maintaining adequate, current, and accurate records of research data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation; Reporting promptly any internal or external adverse event that is considered to be unexpected, serious, and possibly or definitely related to the study; Reporting promptly any significant changes in the risk/benefit of study participation; Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible; Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study; Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the applicable company required training modules; Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines.
NewPrincipal Investigator (Psychiatry) Professional Case ManagementPrincipal Investigator (Psychiatry)Garden City, MI$156,600–$266,700 / yearRisks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result; Selection of human subjects and patients for research participation is equitable; Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by company policies and federal regulations; Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by company policies and federal regulations; Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects; The privacy of human research subjects is protected and the confidentiality of data is maintained; Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons). Maintaining adequate, current, and accurate records of research data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation; Reporting promptly any internal or external adverse event that is considered to be unexpected, serious, and possibly or definitely related to the study; Reporting promptly any significant changes in the risk/benefit of study participation; Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible; Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study; Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the applicable company required training modules; Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines.
NewPrincipal Investigator (Neurology) Professional Case ManagementPrincipal Investigator (Neurology)Garden City, MI$156,600–$266,700 / yearRisks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result; Selection of human subjects and patients for research participation is equitable; Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by company policies and federal regulations; Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by company policies and federal regulations; Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects; The privacy of human research subjects is protected and the confidentiality of data is maintained; Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons). Maintaining adequate, current, and accurate records of research data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation; Reporting promptly any internal or external adverse event that is considered to be unexpected, serious, and possibly or definitely related to the study; Reporting promptly any significant changes in the risk/benefit of study participation; Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible; Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study; Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the applicable company required training modules; Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines.
NewClinical Research Program Manager University of ToledoClinical Research Program ManagerToledo, OHThe position provides expert advice to University of Toledo (UToledo) faculty and principal investigators (PIs), clinical research coordinators, leadership and other personnel involved in the execution of clinical trials throughout the lifecycle. Job Description: This role is responsible for leading the clinical trials operations team and providing oversight for clinical research coordinating staff for supported groups.
NewClinical Research Coordinator Senior University of MichiganClinical Research Coordinator SeniorAnn Arbor, MIIn this role, the CRC Lead will coordinate and oversee regulatory activities, support harmonization of regulatory processes across participating sites, and work closely with the Principal Investigator, study leadership, and participating research teams to ensure compliance with applicable regulatory and study requirements. The CRC Lead will work closely with PCCM Project Managers and Principal Investigators, multidisciplinary clinical partners, internal and external study teams, and other stakeholders to ensure high-quality and efficient execution of the PCCM clinical research portfolio.
NewClinical Instructor-Clinical Professor University of MichiganClinical Instructor-Clinical ProfessorAnn Arbor, MIGlobally Respected Institution: Home to 150+ clinical and research faculty across 12 state-of-the-art locations where we provide comprehensive and subspecialized vision care and conduct groundbreaking research that changes lives. Collaborative Environment: Enjoy rich opportunities to work alongside top clinicians and researchers while partnering across U-M's leading schools in engineering, public health, business, and more.
Clinical Research Coord Senior University of MichiganClinical Research Coord SeniorAnn Arbor, MITechnical Skills: Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel) and experience with research database and data management software such as REDCap (building a database, managing and troubleshooting); familiarity with file-sharing, reference management, communication platforms including Dropbox, google drive, Zotero, end note, etc. Research & Regulatory: Must have experience supporting study start-up, starting IRB applications from scratch and related submissions, study management, and closeout phases, including familiarity with general IRB processes, eResearch, and regulatory documentation.
Clinical Research Associate (CRA) - Oncology (Remote) Merck & Co IncClinical Research Associate (CRA) - Oncology (Remote)Ann Arbor, MIRemote$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Clinical Research Associate (Cra) - Oncology (Remote) Merck & Co., Inc.Clinical Research Associate (Cra) - Oncology (Remote)Detroit, MIRemote$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Clinical Instructor - Clinical Professor University of MichiganClinical Instructor - Clinical ProfessorAnn Arbor, MIFrom diagnosis and medical management of common cardiac disorders to groundbreaking therapies for complex congenital heart conditions, our team is committed to providing the most advanced evidence-based care for infants, children and adolescents with all forms of congenital and acquired heart disease, as well as for adults with congenital heart disease. The congenital catheterization laboratory offers congenital heart patients cutting-edge, minimally invasive care including the new Medtronic Harmony transcatheter pulmonary valve, hybrid procedures in collaboration with cardiac surgery, and participation in clinical trials such as the new ASD bioresorbable device trial (ASCENT).
Clinical Research TechnicianClinical Research Assistant Underfill University of MichiganClinical Research TechnicianClinical Research Assistant UnderfillAnn Arbor, MIThe Clinical Research Technician will also gain key skills in human subjects research process from start to finish, gain experience in 1:1 participant contact and expand knowledge on the intersection of community engagement and innovative research to improve risk reduction and substance use prevention services, particularly in underserved rural areas. In this role, the Clinical Research Technician will: Perform in-person and remote participant facing research activities including (but not limited to): engaging potential participants, screening for eligibility, conducting informed consent procedures, coordinating and scheduling research visits, and completing data collection and entry via survey/qualitative interviews/panels, etc.
Clinical Research Program Manager University of MichiganClinical Research Program ManagerAnn Arbor, MIThe Center?s mission is to optimize cardiometabolic health and reduce cardiovascular risk across the health system through a data science-driven, risk-based approach spanning six integrated cores: Population and Data Science, Phenotyping, Cardiometabolic Health Clinic and Clinical Trials, Health System Implementation, Industry and Academic Partnerships, and Training and Education. The Clinical Research Program Manager will serve as the operational backbone of this multidisciplinary clinical research enterprise, providing administrative and scientific coordination across active clinical trials, observational studies, and translational research initiatives.
NewClinical Research Technician University of MichiganClinical Research TechnicianAnn Arbor, MIWorks with investigator to: establish and implement procedures for ensuring data quality; review preliminary descriptive statistics from analyses to identify potential problems with data, and initiate corrective action; develop primary data collection/entry protocols, training and procedures manuals; monitor field procedures to determine compliance with protocol. Seeking a highly motivated, responsible, and detail-oriented Research Assistant to work collaboratively with project managers, program staff, therapists and investigators on a clinical trial examining effective treatments for PTSD.
Senior Clinical Research Associate - CNS/Rare Disease - Midwest (Remote) Worldwide Clinical Trials Holdings IncSenior Clinical Research Associate - CNS/Rare Disease - Midwest (Remote)MIRemote$97,000–$193,000 / yearTypically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
NewClinical Research Coord Inter University of MichiganClinical Research Coord InterAnn Arbor, MICertification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. The CRC Intermediate will work within a small team to recruit participants, screen for eligibility, schedule appointments, collect informed consent, collect survey data, and administer tailor-made interventions one-on-one with parents over a period of 6 to 8 weeks per family.
NewClinical Research Coordinator U.S. Renal Care, Inc.Clinical Research CoordinatorToledo, Ohio$62,231–$77,789 / yearFull timeClinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
Senior Clinical Data Manager (Remote - US) MMSSenior Clinical Data Manager (Remote - US)Canton, MIRemoteProvides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits. Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.
Per Diem Clinical Research Nurse - Home Visits Science 37Per Diem Clinical Research Nurse - Home VisitsDetroit, MI$50–$55 / hourWith interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials.
Clinical Research Coordinator II Flourish ResearchClinical Research Coordinator IIDetroit, MichiganFlourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources.
Clinical Research Coord Tech underfill Asst. University of MichiganClinical Research Coord Tech underfill Asst.Ann Arbor, MIPlease review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research. Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.