Biorepository Protocol Coordinator

Nationwide Children's Hospital•Columbus, OH

21h•Onsite

About The Position

Develops, onboards, coordinates, and manages clinical trial study and research objectives. Meets requirements, follows regulatory guidelines, and observes standard operating procedures. Coordinates and executes activities with ongoing study development and process improvement.

Requirements

Bachelor’s Degree in Science, Business Administration, or other related field, required.
Working knowledge of PCs and word processing and data management software, required.

Nice To Haves

Understanding of medical terminology and clinical trials, preferred.
Three years of academic or professional experience in clinical research or health care field OR three years of experience in clinical trials, oncology, or health care business development, preferred.

Responsibilities

Reviews specimen documentation and related documents (including regulatory requirements).
Verifies and inputs data related to specimens, including quality control or laboratory results.
Organizes clinical research studies, monitors, reviews, and tracks specimen-related data.
Verifies specimen data entry accuracy, identifies discrepancies, problem-solves, and collaborates to resolve issues.
Manages new and existing projects to ensure information is documented and relayed accurately and timely.
Identifies and develops project plans, beginning and end dates, tasks, resources, and expectations of resources.
Enters metrics, write reports; provides input into revisions, timeframes, and process improvement.
Oversees, reviews, edits, and prepares project related documents such as protocols and statements of work, reviews regulatory documents, and other project documents as required by sponsors.
Creates and modifies reference documents to facilitate standardized data collection and aid in protocol execution, management, and record keeping.
Ensures documentation is completed in compliance with regulatory requirements.
Serves as a point of contact and project coordinator, interacts with internal teams, external customers, and project sponsors in receiving and relaying pertinent information necessary to resolve issues and complete activities per trial or project requirements.
Provides useful feedback in a professional manner.
Trains and educates staff relevant to project/study activities.
Actively promotes a cohesive, positive, and team-oriented work environment and possesses a solution-driven mentality.