Clinical Research Coordinator III - Hematology

Cincinnati Children's•Brewster, MA

2d•$56,784 - $62,150•Onsite

About The Position

This role is responsible for the conduct of clinical research studies, ensuring compliance with all regulatory requirements and institutional policies. The Clinical Research Coordinator III will manage study activities from initiation to closeout, including participant recruitment, data management, and regulatory submissions. This position serves as a key resource for the study team and collaborates with investigators, sponsors, and other healthcare professionals to ensure the successful and ethical execution of clinical trials in Hematology.

Requirements

Bachelor's degree in a related field AND 1+ years of directly related experience OR Master's degree in a related field

Responsibilities

Maintain awareness of the status of all active studies, arranging for facilities and supplies.
Ensure participant and study compliance, including the collection of study specimens and adherence to study visits.
Work with the study team to define specimen collection, processing, and storage procedures.
Train others as needed to collect and label samples as instructed and process them in accordance with the protocol, manual of operations, SOPs, or other work instructions.
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 the preparation and conduct of clinical trials.
Prepare, submit, and maintain all regulatory submissions (proposed new studies, annual reviews, amendments, and adverse events) accurately and within a timely manner to all collaborative parties.
Periodically self-audit records to ensure audit-readiness.
Prepare, plan, and participate in all monitor visits, audits, and quality reviews (internal and external) in a professional manner.
Oversee 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 (e.g., the need for review by additional divisions, regulatory agencies, or consultants) and coordinate the process to meet these requirements.
Apply legal, regulatory, and policy parameters to promote ethical practices in research involving human participants and to ensure compliance with those regulations.
Document the conduct of each protocol's regulatory activities in appropriate systems.
Maintain up-to-date and accurate written and electronic records and files to support clinical research activities.
Continuously update knowledge of regulatory requirements.
May act on behalf of the PI in communicating with sponsors, other divisions, or institutions to coordinate studies and follow through on issues.
Determine the best method(s) to identify potential participants for research protocols (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 the consent form with the participant and provide time for the 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 and completeness of the 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 statisticians, 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.