Biorepository Protocol Coordinator- RI Stover

Nationwide Children's Hospital•Columbus, OH

About The Position

Overview: Job Description Summary: 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. Job Description: Essential Functions: 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.

Requirements

Bachelor’s Degree in Science, Business Administration, or other related field, required.
Understanding of medical terminology and clinical trials, preferred.
Analytical, scientific, organizational, or laboratory knowledge to understand and evaluate specimen and data related to clinical trials and research projects, understand complex information, and effectively manage day to day activities of studies.
Must have a thorough attention to detail, be goal-oriented, and self-directive.
Robust verbal and written communication skills to effectively interact and maintain relationships at all levels.
Demonstrates the ability to change manner of communication styles to adapt to various cultural and work-style differences.
Demonstrates the ability to work efficiently and independently promoting a team environment.
Helps others stay productive, motivated, and creative.
Demonstrates the ability to adjust to change, handle interruptions and function with changing circumstances.
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.
Working knowledge of PCs and word processing and data management software, required.
OCCASIONALLY: Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Climb stairs/ladder, Communicable Diseases and/or Pathogens, Decision Making, Fume /Gases /Vapors, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Loud Noises, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Reaching above shoulder
FREQUENTLY: Bend/twist, Squat/kneel
CONTINUOUSLY: Audible speech, Color vision, Computer skills, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Lifting / Carrying: 0-10 lbs, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near, Sitting, Standing, Walking

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.