Clinical Research Coordinator

The Clinical Research Coordinator (CRC) is responsible for supporting and overseeing the day-to-day operations of clinical studies and evaluations, assisting with recruiting and screening of study participants, as well as documenting and reporting on the daily operations of assigned trials.

Additionally, in collaboration with the Principal Investigator, Co-Investigators, and additional staff, the CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of clinical studies.

The CRC works collaboratively with the entire team, the sponsor(s) and the IRB to ensure productivity, quality, and timely completion of studies.

The CRC is expected to support, monitor, guide, train and lead clinical trial team members in the implementation of trial-related activities.

The CRC applies critical thinking and creative problem-solving skills across a wide variety of oral healthcare related clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities. General Responsibilities

• Ensure compliance with Good Clinical Practice (GCP) when applicable.
• Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies and clinical evaluations.
• Serve as a resource for other clinical research professionals in all aspects of conducting clinical trials.
• Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout.
• Work with the Regulatory team and the IRB to determine which research protocols or issues have additional requirements (i.

e., the need for review by additional divisions, regulatory agencies, or consultants) & coordinates 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.
• Work closely with the Institutional Review Boards (IRB) to gain study approval when applicable.
• Maintain up to date & accurate records & files to support clinical research activities.
• Will work closely with Investigators and staff 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 and prepare accordingly.
• Create and maintain a detailed tracking system for participants considered for enrollment when applicable.
• Track progress at regular intervals and report out to PI and / or management.
• Help to prepare informed consent forms for clinical studies and evaluations.
• Communicate challenges with recruitment and retention to UPI stakeholders.
• Make recommendations to improve recruitment and retention to UPI stakeholders.
• Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them.
• Serve as the liaison to internal departments, clinical teams, regulatory agencies, physician's offices, city clinics, academic centers, and other organizations as necessary.
• Communicate study related issues to investigators, sponsors, coordinating centers, clinical and research teams, regulatory and the IRB when appropriate.
• Review study documentation to ensure completeness, accuracy, and compliance with Good Clinical Practice when applicable.
• Review documentation from internal and external sources to ensure accuracy.
• 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.
• 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.
• Train new staff as needed in preparation for and the conduct of clinical trials.
• Periodically self-audit records to ensure audit-readiness.
• Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner and assist with site accreditation process.

Qualifications

• Active Clinical Research Coordinator Certificate Preferred
• Bachelor's Degree in a health or science related field preferred but other equivalent degrees will be considered
• Strong organizational and project management skills to handle projects independently.
• Must maintain a valid driver’s license and the ability to drive to monitoring sites.
• Proficient knowledge of Microsoft® Office Suite, Adobe.
• Strong communication and presentation skills.
• Must be detail-oriented and efficient in time management.
• Must have full understanding of Good Clinical Practice (GCP).
• Demonstrates an independent work initiative, sound judgment, diplomacy and professional demeanor.
• Experience with Agile, CITI and IRB software is a plus.
• 3-5 years of experience with Medical Devices, Feasibility Studies and Investigation Device Exemptions (IDE) preferred.
• Experience as a Clinical Research Coordinator (minimum 3-5 years).
• Experience working with patient's customers for evaluation's, good bed side manner
• Ability to follow HIIPA
30+ days ago