- 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.
- 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.
- 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.
- 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.
- 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. Qualifications
-
Human Genetics Physician Opportunity
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United States Full timeHuman Genetics Physician Opportunity Description Human Genetics Physician Opportunity · The Division of Human Genetics at Cincinnati Children's seeks Staff Physicians to deliver safe and effective medical care to their genetics patients. The successful candidate will be an emp ...
-
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesThe Division of Human Genetics at Cincinnati Children's has several Assistant/ Associate Professor - Clinical opportunities to join our team of specialists with a wide variety of backgrounds, areas, and focus. · Our team leverages genomic technology to provide world-class clinica ...
-
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 StatesExpected Starting Salary Range: - Salary commensurate with experience. · We are looking for a highly motivated individual with a PhD (or equivalent) degree in molecular genetics, molecular biology, or related field, who is passionate in applying life science knowledge to clinical ...
-
Research Assistant II
3 weeks ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: · The self-motivated applicant will work in the Baglaenko Lab within the Division of Genetics. This human immunology focused group studies the basis of autoimmune disease using techniques in genomics, genetics, and systems biology with an emphasis ...
-
Postdoctoral Research Fellow
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: - Follows NIH extramural postdoctoral payscales · Dr. Biplab Dasgupta's laboratory is looking for a highly motivated, self-driven and ambitious postdoctoral researcher to start this summer/fall in the Division of Oncology. Using genetically enginee ...
-
Research Fellow-Acute Myeloid Leukemia
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesPostdoc positions available in the Grimes laboratory (@LeeGrimesLab) at Cincinnati Children's Hospital Medica Center, in Cincinnati Ohio (an affordable metro area of more than 2 million people, with access to the arts, great restaurants, excellent schools and parks). · Dual train ...
-
RN Registered Nurse
2 weeks ago
Mercy Health Cincinnati, OH, United StatesEveryone who works with Mercy Health is united under one purpose: to help our patients be well in mind, body and spirit. This drive, along with our history of faith, is a powerful combination. It gives us a shared calling to work toward every day. Join our exceptional team and he ...
-
Experimental Hematology
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExperimental Hematology & Cancer Biology Field SVC Asst Professor Research Opportunity · Salaried position · The Division of Experimental Hematology and Cancer Biology at Cincinnati Children's has an excellent opportunity to join our translational research team. · The Division of ...
-
Direct Support Professional
10 hours ago
Sevita Springdale, United States Full timeREM Community Services, a part of the Sevita family, provides community-based services for individuals with intellectual and developmental disabilities. Here we believe every person has the right to live well, and everyone deserves to have a fulfilling career. You'll join a missi ...
-
Postdoctoral Research Fellow
3 weeks ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: Salary aligns with NIH extramural postdoc payscales · There is an immediate opening for a Postdoctoral Research Fellow in the Jiang Laboratory in the Division of Developmental Biology. The long-term goal of research in the Jiang Laboratory is to un ...
-
People Operations Specialist
2 weeks ago
FIS Global Cincinnati, United States OTHERPosition Type : · Full time Type Of Hire : · Experienced (relevant combo of work and education) Education Desired : · Bachelor of Human Resources Travel Percentage : · 5 - 10%Job Description · About the team · Are you curious, motivated, and forward-thinking? At Worldpay, you ...
-
Reentry Program Outreach Coordinator
1 week ago
Hamilton County (OH) Cincinnati, United StatesJob Title: Reentry Program Outreach Coordinator · Location: Cincinnati, Ohio/ Working Offsite When Needed · Your Benefits of Working for Hamilton County · * Flexible and Potential Hybrid Work from Home Option. · * Starting Pay: $ 53,872 annually · * Generous Paid Time Off: 11 Pai ...
-
Benefits Analyst
3 weeks ago
VORA VENTURES, LLC Cincinnati, United StatesBenefits Analyst & Human Resources Generalist, Vora Ventures · Vora Group is looking for a Human Resources Generalist specializing in Benefits Administration to join our growing human resources team. This role will split their time between backend administration and front-facing ...
-
Student II/III
1 week ago
Cincinnati Children's Hospital Medical Center Cincinnati, United StatesExpected Starting Salary Range: - · $13 - $15 · Job Description: · The Assistant Curator is a key member of the Xenbase team. The primary task is to review newly published scientific literature, preparing the paper for further curation by our PhD level biocurators. All of this is ...
-
Bon Secours Mercy Health Cincinnati, United StatesAt Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence. · As a faith-based and patient-focused organization, Mercy H ...
-
LPN Licensed Practical Nurse
1 week ago
Mercy Health Cincinnati, United StatesThank you for considering a career at Mercy Health · Mercy Health · About Us · As a faith-based and patient-focused organization, Mercy Health exists to enhance the health and well-being of all people in mind, body and spirit through exceptional patient care. Success in this goal ...
-
Clinical Supervisor
1 week ago
Mercy Health Cincinnati, United StatesThank you for considering a career at Mercy Health · Mercy Health · About Us · As a faith-based and patient-focused organization, Mercy Health exists to enhance the health and well-being of all people in mind, body and spirit through exceptional patient care. Success in this goal ...
-
Student, Rad Technologist The Jewish Hospital
3 weeks ago
Mercy Health Cincinnati, United StatesThank you for considering a career at Mercy Health · As a faith-based and patient-focused organization, Mercy Health exists to enhance the health and well-being of all people in mind, body and spirit through exceptional patient care. Success in this goal requires a culture of com ...
-
Clinical Supervisor
1 week ago
Bon Secours Mercy Health Cincinnati, United StatesAt Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence. · **Mercy Health** · **_About Us_** · As a faith-based and p ...
Clinical Research Coordinator ll or III Human Genetics - 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
·Study Conduct/ Clinical Research Practice
·Regulatory Compliance and Documentation
·Recruitment/Enrollment/Retention
·Communication
·Data Management
Required for Clinical Research Coordinator II
·High school diploma or equivalent AND 2 years of work experiencein a related job discipline OR
Preferred:
·Bachelor's degree in a related field
Required for Clinical Research Coordinator III
·
·Bachelor's degree in a related field and 1 year of directly related experience OR Master's degree in a related field.
Job
ResearchShift
Day JobJob Type
StandardDepartment
Human Genetics
Employee Status
RegularFTE
1.0
Weekly Hours
40
Salary Range
Clinical Research Coordinator ll or III Human Genetics professionals in Cincinnati
-
Jaleesa Spencer
Data Entry for AI Development