Clinical Research Coordinator III

1 month ago

Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

Expected Starting Salary Range: 27.30

SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.

REPRESENTATIVE RESPONSIBILITIES

* Study Conduct/ Clinical Research Practice
* Maintain awareness of status of all active studies.
* Arrange for facilities and supplies.
* Ensure participant and study compliance, i.e. collection of study specimens, and study visits.
* Work with study team as needed to define specimen collection, processing and storage procedures.
* Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set.
* Ensure specimens are properly logged, handled and stored.
* Maintain all records and files required by regulatory agencies and sponsors.
* Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial. Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies.
* Train new staff in preparation and conduct of clinical trials.
* Regulatory Compliance and Documentation
* Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties.
* Periodically self-audit records to ensure audit-readiness.
* Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner.
* Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout.
* Determine which research protocols or issues have additional requirements, e.g. the need for review by additional divisions, regulatory agencies, or consultants, & coordinate the process to meet these requirements.
* Apply legal, regulatory & policy parameters to promote ethical practices in research involving human participants & to ensure compliance to those regulations.
* Document the conduct of each protocol's regulatory activities in appropriate systems.
* Maintain up-to-date & accurate written & electronic records & files to support clinical research activities.
* Continuously update knowledge of regulatory requirements.
* May act on behalf of the PI in communicating with sponsor, other divisions or institutions to coordinate studies & follow through on issues.
* Recruitment/Enrollment/Retention
* Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly.
* Create and maintain a detailed tracking system for participants considered for enrollment.
* Track progress at regular intervals and report out to PI and or management.
* Identify potentially eligible participants.
* Conduct pre-consent screening to determine eligibility. Review consent form with participant and provide time for participant to consider study participation. Execute the informed consent process according to GCP and CCHMC procedures and other applicable rules, regulations and policies. Communicate with participants' clinical team regarding study participation.
* Document in applicable systems (tracking, electronic health, etc.) participants approached, screened and enrolled in the study.
* Communicate challenges with recruitment and retention to the study leadership.
* Make recommendations to improve recruitment and retention to the study leadership.
* Engage study staff to assist in identifying and enrolling participants.
* Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them.
* Communication
* Compose, document, organize, and maintain all correspondence.
* Oversee and follow through on questions and issues that arise during study conduct.
* Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's offices, city clinics, government agencies, academic centers, and other organizations.
* Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical and research teams, managers and other institutions.
* Develop a rapport with study participants.
* Data Management
* Create CRFs in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
* Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines for human research.
* Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
* Review documentation from sources to ensure accuracy.
* Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation to ensure accuracy, completeness of data collection process. Perform data cleaning procedures and quality checks to ensure accuracy of data.
* Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Review reports, tables, and listings.
* Assist in data analysis and maintain record keeping and data storage for clinical research studies.
* Maintain master database files for clinical research protocols.
* Prepare reports from validation studies of clinical research projects.

EDUCATION/EXPERIENCE

Required:

* Bachelor's degree in a related field
* ·1 year of directly related experience OR Master's degree in a related field

Preferred:

Unique Skills:

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).

  • Clinical Research Coordinator III Hospital Medicine

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coordinator III Hospital Medicine

    4 weeks ago

    Cincinnati, Ohio, United States Cincinnati Children's Hospital Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coordinator III

    4 weeks ago

    Cincinnati, Ohio, United States Cincinnati Children's Hospital Medical Center Full time

    Expected Starting Salary Range: 27.30SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject...

  • Clinical Research Coordinator ll or III Human Genetics

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coordinator ll or III

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coordinator lll/lV Asthma Research

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coordinator III

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coordinator II/lll/lV Allergy

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Clinical Research Coord III

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    Expected Starting Salary Range: 20.71 - 25.24 SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality,...

  • Clinical Research Coordinator

    4 weeks ago

    Cincinnati, Ohio, United States Gastro Health Full time

    Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours. This role offers: A great work/life balance No weekends or evenings – Monday thru Friday Paid holidays and...

  • Clinical Research Coordinator

    1 month ago

    Cincinnati, United States Gastro Health Full time

    Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team! Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours. This role offers: A great work/life balance No weekends or evenings – Monday thru Friday Paid holidays...

  • Clinical Support Associate

    4 weeks ago

    Cincinnati, Ohio, United States Velocity Clinical Research, Inc. Full time

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites.At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are...

  • Senior Clinical Research Coordinator or CRC lV

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Research Assistant II/III

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    Expected Starting Salary Range: 19.73 - 24.05 (RAII) 23.02 - 28.06 (RA III) The LSCS conducts high-quality infectious disease and immunological testing to support clinical trials. We also support the Cincinnati Children's Hospital Medical Center as one of eight NIH-funded Vaccine Testing and Evaluation Units. The laboratory capabilities include development...

  • Clinical Research Coordinator

    3 weeks ago

    Cincinnati, United States Pioneer Data Systems Full time

    Our client, a world-leading Pharmaceutical Company is currently looking for a Clinical Research Coordinator to join their expanding team. Position Details: Job Title: Clinical Research Coordinator / Hybrid work Duration: 3 months contract, extendable up to 24 months Location: Cincinnati, OH Hybrid work: 2-3 days/week Onsite Note: The client has the...

  • Clinical Research Coordinator ll or lll Rheumatology

    1 month ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical...

  • Cincinnati Clinical Research Project Coordinator

    1 month ago

    Cincinnati, United States Medpace Full time

    Job Summary Medpace is a leading CRO for Biotech companies and we are currently seeking a full-time, office-based Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. Our therapeutic areas of focus include Oncology/Hematology,...

  • Clinical Research Project Coordinator- Ophthalmology

    1 month ago

    Cincinnati, United States Medpace Full time

    Job Summary Medpace is a leading CRO for Biotech companies and we are currently seeking a full-time, office-based Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. Our therapeutic areas of focus include Microbiology,...

  • Clinical Research Project Coordinator- Cardiovascular

    1 month ago

    Cincinnati, United States Medpace Full time

    Job Summary Medpace is a leading CRO for Biotech companies and we are currently seeking a full-time, office-based Project Coordinator to join our Clinical Trial Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. Our therapeutic area of focus includes...

  • Study Start-Up Coordinator

    1 month ago

    Cincinnati, United States Medpace Full time

    Job Summary Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up...