Senior Clinical Research Coordinator

2 weeks ago

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

SUBFUNCTION DEFINITION: The field of healthcare science dedicated to assessing the safety and efficacy of medications, devices, diagnostic products, and treatment regimens intended for human application. These interventions may serve purposes such as prevention, treatment, diagnosis, or alleviation of disease symptoms. The primary objective is to ensure quality, safeguard human subjects, and maintain data integrity throughout clinical trials conducted within the designated department.


REPRESENTATIVE RESPONSIBILITIES


·Study Management/Clinical Research Practices
  • Maintain a comprehensive understanding of the status of all ongoing studies.
  • Coordinate the necessary facilities and supplies.
  • Ensure compliance of participants and studies, including the collection of study specimens and adherence to study visit schedules.
  • Collaborate with the study team to establish procedures for specimen collection, processing, and storage.
  • Provide training to others on sample collection, labeling, and processing in accordance with protocols and standard operating procedures (SOP).
  • Ensure proper logging, handling, and storage of specimens while maintaining all records required by regulatory bodies and sponsors.
  • Act as a resource for fellow clinical research professionals in all facets of trial conduct.
  • Work alongside investigators and colleagues to guarantee the successful progression and completion of clinical studies.
  • Train new personnel in the preparation and execution of clinical trials.

·Regulatory Compliance and Documentation
  • Prepare, submit, and maintain all regulatory documentation (new study proposals, annual reviews, amendments, and adverse events) accurately and promptly.
  • Conduct periodic self-audits of records to ensure readiness for external audits.
  • Plan and participate in all monitoring visits, audits, and quality reviews in a professional manner.
  • Oversee the review and approval process of human research protocols with all regulatory authorities, including study closeout.
  • Identify research protocols requiring additional review and coordinate the necessary processes.
  • Apply legal, regulatory, and policy frameworks to uphold ethical research practices involving human participants.
  • Document all regulatory activities related to each protocol in appropriate systems.
  • Maintain accurate and up-to-date written and electronic records to support clinical research activities.
  • Continuously enhance knowledge of regulatory requirements.
  • May represent the Principal Investigator in communications with sponsors and other divisions to coordinate studies.

·Recruitment/Enrollment/Retention
  • Identify optimal methods for locating potential participants for research protocols (advertisements, chart reviews, monitoring clinic schedules, etc.) and prepare accordingly.
  • Create and maintain a detailed tracking system for potential participants.
  • Monitor progress regularly and report findings to the Principal Investigator or management.
  • Identify potentially eligible participants and conduct pre-consent screenings to assess eligibility.
  • Review consent forms with participants, allowing them time to consider study participation.
  • Execute the informed consent process in accordance with Good Clinical Practice (GCP) and institutional procedures.
  • Communicate with participants' clinical teams regarding study involvement.
  • Document participant interactions in relevant systems (tracking, electronic health records, etc.).
  • Address recruitment and retention challenges with study leadership.
  • Propose strategies to enhance recruitment and retention efforts.
  • Engage study staff in identifying and enrolling participants.
  • Proactively identify and address barriers to recruitment.

·Communication
  • Compose, document, organize, and maintain all correspondence related to the study.
  • Oversee and resolve questions and issues that arise during the study.
  • Serve as a liaison to internal departments, clinical teams, regulatory agencies, and other organizations.
  • Communicate study-related issues to investigators, sponsors, and other stakeholders.
  • Develop rapport with study participants to facilitate engagement.

·Data Management
  • Create Case Report Forms (CRFs) in collaboration with team members, utilizing existing study data to streamline data collection.
  • Complete CRFs and source documentation in compliance with applicable human research guidelines.
  • Review CRFs for completeness, accuracy, and adherence to Good Clinical Practice.
  • Verify documentation from various sources for accuracy.
  • Enter data into auditable databases or electronic data-capture systems, ensuring data accuracy and completeness.
  • Conduct data cleaning and quality checks to ensure data integrity.
  • Support the data management process for clinical research projects, addressing queries from data managers and sponsors.
  • Review reports and assist in data analysis while maintaining records 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 relevant field
·1 year of directly related experience OR Master's degree in a relevant field
Preferred:

Unique Skills:
Cincinnati Children's is an Equal Opportunity Employer that values Diversity, Equity, and Inclusion. We are dedicated to fostering an environment of dignity and respect for all employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability, or protected veteran status. EEO/AA/M/F/Veteran/Disability

Job: Research

Shift: Day Job

Job Type: Standard

Department: Urology Surgery

Employee Status: Regular

FTE: 1.00

Weekly Hours: 40

Salary Range:

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