- 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.
- High school diploma or equivalent
- 2 years of work experience in a related job discipline. or equivalent combination of education and experience
- May require an Associate degree, vocational training, apprenticeships or equivalent
- Bachelor's degree in a related field and 1 year of directly related experience OR Master's degree in a related field
-
Clinical Research Coordinator III
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesSUBFUNCTION 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 ...
-
Clinical Research Coordinator III
5 days ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected 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, ...
-
Cincinnati Children's Hospital Cincinnati, United StatesSUBFUNCTION 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 ...
-
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesSUBFUNCTION 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 ...
-
Cincinnati Children's Hospital Medical Center Cincinnati, United States Full timeSUBFUNCTION 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 ...
-
General Manager
5 days ago
Nothing Bundt Cakes - Clermont, FL Clermont, United StatesTITLE: Bakery Manager/Lead Operator · REPORTS TO: District Manager · SUPERVISES: Up to 30 Bakery Team Members · Position Summary: · The Nothing Bundt Cakes (NbC) Bakery Manager/Lead Operator directs the team and day-to-day operation, which includes all aspects of the guest experi ...
-
Research Assistant III
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: · SUBFUNCTION DEFINITION: The Research Assistant III will support the ACTION (Advanced Cardiac Therapies Improving Outcomes Network) DCC (Data Coordinating Center). Core responsibilities will include data analysis, abstract and manuscript preparat ...
-
Academic Coach
1 week ago
Educational Empowerment Group Cincinnati, United StatesPlease consider the following job responsibilities in the areas of Leadership, Accountability, Support and Communication when contemplating candidates for an Academic Coach. An effective Academic Coach will spend 50-60% of their time on classroom coaching with teachers (planning, ...
-
Lab Technical Specialist
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: $71, ,000 · SUBFUNCTION DEFINITION: Candidates should have demonstrated expertise in immunoassays (ELISA, Luminex, associated automation). Responsibilities include the technical oversight of testing in this high volume protein biomarker laboratory. ...
-
Clinical Research Coordinator II or lll
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesSUBFUNCTION 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 ...
-
Licensed Therapist
2 days ago
Pinnacle Treatment Centers Cincinnati, United States Full timeOverview: Schedule options: M-F 5:30am-2p with rotating Saturdays · or · Tuesday through Friday 6a-3p, Saturdays 5:15a-10a · We offer competitive salaries, full benefits package, Paid Time Off, and opportunities for professional growth. · Pinnacle Treatment Centers is a growing ...
-
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesSUBFUNCTION 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 ...
-
Neonatology Newborn Hospitalist
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: - Exempt · Neonatology Newborn Hospitalist · The Perinatal Institute at Cincinnati Children's is currently seeking a Full-time, Inhouse, Staff Physician Neonatologist and/or Newborn Special Care Nursery Hospitalist to focus on neonatal programs in ...
-
Substance Abuse Counselor
3 days ago
Community Medical Services West Chester, OH, United StatesOverview: · Shift: Monday - Friday 5:15am - 1:15pm with rotating Saturdays 6am - 10am · Community Medical Services (CMS) is hiring a Substance Abuse Counselor to assist patients recovering from addictions to opioids and other illicit substances. Whether facilitating individual or ...
-
Licensed Substance Abuse Counselor
3 days ago
Community Medical Services West Chester, United StatesOverview: · Shift: Monday-Friday 6:00am - 2:00pm, One Saturday per month 6:00am - 10:00am · Community Medical Services (CMS) is hiring a Substance Abuse Counselor to assist patients recovering from addictions to opioids and other illicit substances. Whether facilitating individua ...
-
Research Assistant II/III
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: RAII 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 ...
-
Research Assistant II/III
5 days ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: RA II RA III) · Founded in 2008, the Pluripotent Stem Cell Facility (PSCF) was one of the first shared facilities in the United States to support hPSC research. Since then, our services and training have expanded significantly but our mission remai ...
-
UC Health Cincinnati, United StatesLocation: West Chester Hospital, Metabolic Center · Department: Inpatient Pharmacy · Hours: Full-Time, 40 Hours / Weekly · Shift: First Shift · UC Health is hiring a full-time Clinical Pharmacy Specialist in Inpatient Pharmacy at West Chester Hospital, Metabolic Center · Unde ...
-
Clinical Research Coordinator lll or IV
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesSUBFUNCTION 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 ...
-
emergency department registered nurse
1 week ago
Insight Global Cincinnati, OH , USA, United StatesA Hospital in the Cincinnati area provides its patients with access to the region's largest group of specialized physicians and medical providers. With a reputation for providing outstanding patient experiences and quality medical care, the hospital consistently ranks amongst the ...
Clinical Research Coordinator ll or III - Cincinnati, United States - Cincinnati Children's Hospital Medical Center
Description
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
Clinical Research Coordinator ll or III professionals in Cincinnati
-
Jaleesa Spencer
Data Entry for AI Development
-
Cedric Rose
Writer, Researcher, Librarian