Biorepository Protocol Coordinator- RI Stover

Nationwide Children's Hospital

Job Location:

Columbus, NE - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

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.

Education Requirement:

Bachelors Degree in Science Business Administration or other related field required.

Licensure Requirement:

(not specified)

Certifications:

(not specified)

Skills:

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.

Experience:

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.

Physical Requirements:

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

Additional Physical Requirements performed but not listed above:

(not specified)

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified nor is it intended to limit or modify the right of any supervisor to assign direct and control the work of employees under their supervision. EOE M/F/Disability/Vet

Required Experience:

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 improve...

Overview:

Job Description Summary:

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.

Education Requirement:

Bachelors Degree in Science Business Administration or other related field required.

Licensure Requirement:

(not specified)

Certifications:

(not specified)

Skills:

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.

Experience:

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.

Physical Requirements:

FREQUENTLY: Bend/twist Squat/kneel

Additional Physical Requirements performed but not listed above:

(not specified)

Required Experience: