Clinical Research Coordinator III
Cincinnati Children's Office of Academic Affairs and Career Development · Cincinnati, OH · 4 wk ago
Analyst$57k–$64k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate like EEO etc. Must not create sections with filler like "commensurate with experience". Pay: we have Expected Starting Pay Range $56,784.00 - $63,960.00 and note about starting pay based on experience, etc. So we can include Pay section with that range. Schedule: we have Shift Day, Schedule Full time, Weekly Hours 40, FTE 1. So we can include Schedule section with those details. Benefits: Not explicitly listed; there is mention "Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply." That's vague; not specific benefits. So we should not create Benefits section because no specific benefits listed. Skills: Not explicitly listed; maybe we can infer from responsibilities but we should not invent. The posting includes "Knowledge of statistical process control principles" under Job Qualifications. That could be a skill. But we need a Skills section only if there is real specific content. There's "Knowledge of statistical process control principles" which is a skill/knowledge. Could put under Skills. However we also have Qualifications: Bachelor's degree etc. So we can have Qualifications section with degree and experience. Requirements maybe same as Qualifications? The instructions: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to decide which sections to include based on content.
We have About the role? Not explicitly a section but we could use the introductory paragraph about location, department, shift etc as About the role? The posting includes "Primary Location Burnet Campus Department Psychiatry Shift Day (United States of America) Schedule Full time Weekly Hours 40 FTE 1 Employee Status Regular Expected Starting Pay Range ..." That's more metadata. Could treat as About the role? But we should not repeat job title. Could create About the role section summarizing location, department, shift, schedule, FTE, employee status. However we already have Schedule and Pay sections separate. Might be redundant. Better to follow instruction: include a section ONLY when posting has real, specific content for it. So we need to see if there is content for About the role: The posting includes location, department, shift, schedule, etc. That could be considered About the role. But we also have separate Schedule and Pay sections. Might be okay to have About the role with location, department, shift, employee status. Then Schedule with weekly hours, FTE, full time. Pay with range. Responsibilities: we have many bullet-like paragraphs. We'll convert to
- . Requirements: maybe we can combine qualifications? The posting has "Job Qualifications Bachelor's degree in a related field 1+ years of directly related experience OR Master's degree in a related field Knowledge of statistical process control principles". That's qualifications. Could treat as Requirements (or Qualifications). We need both Requirements and Qualifications? Might be redundant. Better to have Qualifications section for degree/experience/knowledge, and maybe Skills for something else? But we don't have separate skills list. Could put knowledge of statistical process control under Skills. However the instruction: "Prefer a few substantive sections over many thin ones." So maybe combine Qualifications and Skills into one Qualifications section. But we have headings list; we can choose to include Qualifications and maybe Skills if we have content. Let's see: we have "Knowledge of statistical process control principles" which is a skill/knowledge. Could be under Skills. But we also have degree/experience under Qualifications. So we could have both.
Responsibilities: definitely.
About the role: we have location, department, shift, employee status. That's specific.
Schedule: we have shift day, full time, weekly hours 40, FTE 1.
Pay: we have range.
Benefits: none specific.
Thus output sections: About the role, Responsibilities, Qualifications, Skills, Pay, Schedule.
We must not include empty sections.
Now format: Use
for each heading. Use
- for any list of duties/requirements/benefits. For prose use
. For responsibilities we have many sentences; we can make each responsibility as
- . Could also group into paragraphs but better to list.
We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to include all details from responsibilities, qualifications, etc.
Let's extract responsibilities sections:
- 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.
Now qualifications:
- Bachelor's degree in a related field
- 1+ years of directly related experience OR Master's degree in a related field
- Knowledge of statistical process control principles
We could split: Qualifications: Bachelor's degree, experience/master's. Skills: Knowledge of statistical process control principles.
About the role: location Burnet Campus, Department Psychiatry, Shift Day, United States of America, Employee Status Regular.
Schedule: Shift Day, Schedule Full time, Weekly Hours 40, FTE 1.
Pay: Expected Starting Pay Range $56,784.00 - $63,960.00; Starting pay based on experience, skills, and equity; exceptions may apply for highly qualified candidates; Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply; Annual pay may vary based on FTE status.
We need to preserve all that info. So include the full sentence.
Now we must not include boilerplate like EEO etc. Also remove "Comprehensive Job Description Provided Upon Request." and "About Us" etc. Also remove "Cincinnati Children's Is Recognized..." etc. Also remove "We Embrace Innovation—Together." etc. Also remove "EEO/Veteran/Disability". Also remove "All qualified applicants will receive consideration..." etc.
Now produce HTML fragment.
Structure:
About the role
Primary Location: Burnet Campus; Department: Psychiatry; Shift: Day (United States of America); Employee Status: Regular.
Maybe combine.Responsibilities
- ... each item
Qualifications
- Bachelor's degree in a related field
- 1+ years of directly related experience OR Master's degree in a related field
Skills
- Knowledge of statistical process control principles
Pay
Expected Starting Pay Range $56,784.00 - $63,960.00; Starting pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply. Annual pay may vary based on FTE status.
Schedule:Schedule
- for any list of duties/requirements/benefits. For prose use