Clinical Research Associate

1 month ago

Columbus, Ohio, United States Edwards Lifesciences Full time

Imagine how your expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

We are searching for an Associate Clinical Research Monitor to join Edwards Tricuspid team based in the Midwest region. As the Associate Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The ideal candidate will reside in Midwest/Northeast region.

How you'll make an impact:

  • Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
  • Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
  • Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
  • Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
  • Develop and deliver training on GCPs, protocols, and database, compliance, device accountability, and adverse event reporting.
  • Edit/amend informed consent documents.
  • Other incidental duties.

What you'll need (Required):

  • Bachelor's Degree or equivalent in related field.
  • 1 year experience field monitoring experience, quality assurance/control and regulatory compliance OR 1 year experience working in an environment with hands-on clinical research experience encompassing all aspects of the clinical process, including 1) Cardiovascular device trials; and 2) Cath lab, operating room and/or intensive care unit familiarity, preferred.
  • Ability to travel up to 75% for clinical site visits.
  • Covid Vaccination.

What else we look for (Preferred):

  • Substantial computer literacy in MS Office, to include Word, Excel, Adobe and ability to operate general computer software and office machinery.
  • Understanding of cardiovascular anatomy, pathology and physiology.
  • Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting.
  • Technical writing skills (protocols, CRF development, study tools).
  • Ability to communicate and relate well with key opinion leaders and clinical personnel.
  • Experience with electronic data capture.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

  • Clinical Research Nurse

    4 weeks ago

    Columbus, Ohio, United States Evolution Research Group Full time

    Job Title: Clinical Research NurseAt Evolution Research Group, we are seeking a skilled Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will play a vital role in the conduct of clinical trials, ensuring the highest level of patient care and safety.Responsibilities:Dispense and collect investigational products, routine medications,...

  • Clinical Research Manager

    4 weeks ago

    Columbus, Ohio, United States Evolution Research Group Full time

    Job SummaryThe Evolution Research Group is seeking a highly skilled Clinical Research Manager to join our team. As a Clinical Research Manager, you will be responsible for providing primary care to patients within our facility, as well as keeping records of patients' health, creating patient care plans, and administrating diagnostic tests. This role will...

  • Clinical Research Nurse

    1 month ago

    Columbus, Ohio, United States Evolution Research Group Full time

    Job Title: Clinical Research NurseJob Summary:The Evolution Research Group is seeking a skilled Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will play a critical role in the conduct of clinical trials, ensuring the highest level of quality and patient care.Responsibilities:• Dispense and collect investigational products,...

  • Clinical Research Associate I

    3 weeks ago

    Columbus, Ohio, United States Syneos Health inVentiv Health Commercial LLC Full time

    Job Title: Clinical Research Associate I Job Summary: We are seeking a highly motivated and detail-oriented Clinical Research Associate I to join our team at Syneos Health. As a Clinical Research Associate I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to...

  • Physician Assistant or Nurse Practitioner

    3 weeks ago

    Columbus, Ohio, United States Evolution Research Group Full time

    Job Title: Clinical Research Physician Assistant/Nurse Practitioner About the Role: Evolution Research Group is seeking a skilled Physician Assistant/Nurse Practitioner to join our clinical research team. Responsibilities: Monitor and operate medical equipment. Perform physical exams and patient observations. Administer medications and treatments;...

  • Clinical Research Coordinator I

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    We are seeking a full-time Clinical Research Coordinator to join Principal Investigator Dr. Sarah O'Brien's research laboratory at Nationwide Children's Hospital.The successful candidate will be responsible for recruiting and enrolling adolescents and young adults in outpatient clinics, performing research activities, and interfacing with clinical care...

  • Clinical Research Coordinator II

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Clinical Research Coordinator II Job DescriptionNationwide Children's Hospital is seeking a highly skilled Clinical Research Coordinator II to join our team. As a Clinical Research Coordinator II, you will play a critical role in managing all aspects of clinical studies, ensuring compliance with ICH/GCP guidelines and departmental/institutional standard...

  • Clinical Research Coordinator

    4 weeks ago

    Columbus, Ohio, United States Ohio State University Wexner Medical Center Full time

    The Clinical Research Specialist at Ohio State University Wexner Medical Center plays a vital role in the Emergency Departments Health Now Program, a population health-focused initiative that addresses health needs in a proactive manner.As a health promotion advocate, the successful candidate will participate in identifying and intervening with populations...

  • Clinical Research Coordinator I

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Research Coordinator I to join our team at Nationwide Children's Hospital. The successful candidate will be responsible for managing elements of a clinical study to meet all protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating...

  • Research Associate I

    1 month ago

    Columbus, Ohio, United States Actalent Full time

    Job Title: Research Associate IActalent is seeking a highly skilled Research Associate I to join our Analytical Development team. As a key member of our team, you will be responsible for performing GLP method validation and analytical assay support for early-stage research programs.Key Responsibilities:Perform method validations and analytical testing to...

  • Clinical Research Nurse

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Job SummaryThe Clinical Research Nurse will coordinate care for subjects participating in clinical research trials while following applicable regulations. This includes coordinating patient appointments, serving as a point of contact for patient questions and concerns, preparing study documents, attending patient visits with providers, and processing...

  • Clinical Research Nurse Specialist

    4 weeks ago

    Columbus, Ohio, United States Ohio State University Wexner Medical Center Full time

    Clinical Research Nurse Job DescriptionThe Ohio State University Wexner Medical Center is seeking a skilled Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will play a critical role in the coordination and management of clinical research trials.Key Responsibilities:Evaluate patient eligibility and registration for clinical...

  • Clinical Research Coordinator Lead

    4 weeks ago

    Columbus, Ohio, United States Ohio State University Wexner Medical Center Full time

    At Ohio State University Wexner Medical Center, we are seeking an exceptional Clinical Research Coordinator Lead to join our team. This role will play a critical part in the execution of assigned clinical research studies in accordance with approved protocols. As a lead resource, you will be responsible for supervising the recruitment process to maximize...

  • Clinical Trials Assistant

    4 weeks ago

    Columbus, Ohio, United States Evolution Research Group Full time

    Job SummaryWe are seeking a highly skilled Clinical Trials Assistant to join our team at Evolution Research Group. As a Paramedic (PRN), you will play a critical role in the conduct of clinical trials, ensuring the highest level of patient care and safety.Key ResponsibilitiesDispense and collect investigational products, routine medications, and PRN...

  • Clinical Research Coordinator II Position

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Clinical Research Coordinator II Job DescriptionNationwide Children's Hospital is seeking a highly skilled Clinical Research Coordinator II to join our team. As a Clinical Research Coordinator II, you will be responsible for managing all aspects of clinical studies, ensuring compliance with ICH/GCP guidelines and departmental/institutional standard operating...

  • Clinical Research Coordinator I

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    We are seeking a highly skilled Clinical Research Coordinator I to manage key elements of clinical research studies at the Steve and Cindy Rasmussen Institute of Genomic Medicine (IGM) at Nationwide Children's Hospital.Key ResponsibilitiesConducts clinical research studies as outlined in the study protocol, ensuring subject safety throughout the...

  • Clinical Research Coordinator I

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Clinical Research Coordinator I Job SummaryNationwide Children's Hospital is seeking a Clinical Research Coordinator I to manage elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines.Responsibilities:Ensures that the subject meets inclusion/exclusion criteria;Collects and manages research data and subject...

  • Clinical Research Nurse

    4 weeks ago

    Columbus, Ohio, United States Nationwide Children's Hospital Full time

    Clinical Research Nurse Job DescriptionJob Summary: We are seeking a skilled Clinical Research Nurse to coordinate care for subjects participating in clinical research trials at Nationwide Children's Hospital.Key Responsibilities:Coordinate and schedule patient appointments, serve as a point of contact for patient questions and concerns, and prepare study...

  • Research Audiologist

    4 weeks ago

    Columbus, Ohio, United States Ohio State University Wexner Medical Center Full time

    Audiology professional to provide comprehensive audiological services to in- and out-patients at the Ohio State University Wexner Medical Center. Key responsibilities include conducting audiological evaluations and assessments for research studies, as well as providing diagnostic and rehabilitative services.RequirementsLicensure by the Ohio Board of Speech...

  • Pharmacy Research Technician 2

    4 weeks ago

    Columbus, Ohio, United States Ohio State University Wexner Medical Center Full time

    Position SummaryThis position functions to assist the licensed pharmacist in providing patient care services to patients enrolled in clinical trials. This position provides necessary services and information to research, pharmacy, nursing and medical staff.Key responsibilities include:Preparing and packaging of medicationsDistribution of medications,...