Career Center

Description

This position will lead Dr. Nadine Kasparian's clinical research lab. Dr. Kasparian leads Cincinnati Children's Center for Heart Disease and Mental Health, a collaboration between the Heart Institute and the Division of Behavioral Medicine and Clinical Psychology.

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

???Advancement Reviewer

Serve as a regularly participating reviewer in the advancement process as established by the advancement ladder materials.

???Study Conduct/ Clinical Research Practice
Serve in leadership role and as a resource for others for all aspects of conducting clinical trials for complex and multi-center trials.

Directly (or indirectly) supervise other CRCs or support staff involved in clinical research work.

Collaborate on multiple projects or studies of increased complexity.

Serve as a resource for study team members and other divisions that may be involved with specimen collection, processing, storage and tracking for clinical trials.

Lead activities designed to improve organizational performance such as process improvement projects.

Provide input to division discussions.

Work independently and look for opportunities to grow clinical research projects within assigned division.

Act as a role model with a significant expertise, knowledge & experience in coordination of clinical research.

???Regulatory Compliance and Documentation
Manage multiple complex regulatory projects. May lead and supervise regulatory staff.

Organize and manage activities for the preparation, review, submission and maintenance of regulatory activities to collaborative parties. Provide oversight of periodic internal self-audit of records.

May lead monitor visits, audits, and quality reviews (internal and external).

Manage the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout.

Determine which research protocols or issues have additional requirements, i.e. review by additional CCHMC Divisions, regulatory agencies, consultants, and data safety monitoring boards, and coordinate the process to meet these requirements.

Act as an expert resource for regulatory affairs.

Mentor and lead others in applying federal regulations; state and local law; and CCHMC and divisional policies, and SOPs to promote ethical practices in research involving human participants and to ensure compliance to those regulations.

Ensure the documentation of regulatory activities in appropriate systems.

Manage the maintenance of up-to-date and accurate written and electronic records and files.

???Recruitment
Develop, implement and execute recruitment strategies to identify potential participants for large, complex projects.

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.

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, management, and required regulatory agencies.

???Data Management
Develop and maintain data management plan and SOPs for projects.

Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process. Create CRFs in consultation with other team members using existing study data information to promote efficient data collection and data entry.

Create Data Dictionary, per protocol and in conjunction with principal investigator and statistician.

Oversee the design of auditable database, data collection forms, error checking methods, and related programs for collection, analysis, and reporting.

Support the data-management process for clinical research projects, data query management from data managers, project statistician, and sponsors. Maintain and audit data, providing status and activity reports as required.

Organize data to analyze, identify, and report trends. Review reports, tables, and listings.

Perform both quantitative and qualitative analyses.

Maintain data storage for clinical research studies, and master database files for clinical research protocols.

Prepare reports from validation studies of clinical research projects.

Evaluate and resolve discrepancies within reports. Ensure quality of data submitted from study sites and assure timely submission of data.

Oversee the processing of laboratory and other external data.

Qualifications

EDUCATION/EXPERIENCE

Required:

???Bachelor's degree in a related field

??? 7 years of experience in related job discipline OR Master's degree and 6 years experience

??? Certified Clinical Research Coordinator within 18 months of external hire

Preferred:

Unique Skills: