Clinical Research Program Coordinator Non-Rn

Nationwide Children's Hospital Columbus , OH 43216

Posted 2 months ago

Overview

The Clinical Research Program Coordinator's primary responsibility is the overall administrative coordination and management of the department/center's research portfolio. This includes a working knowledge of projects in process as well as funded projects including grant budgets and IRB protocols. The Clinical Research Program Coordinator coordinates subcontracts with other sites and the Sponsored Projects Office, develops and implements processes across multiple study sites and maintains documents to ensure effective, efficient and compliant project progress.

Why Nationwide Children's Hospital?

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose.

Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.

We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children's Hospital. A Place to Be Proud.

Responsibilities

Essential Job Functions

  • Responsible for administrative management, organization of, and participation in program meetings and teleconferences, including scientific meetings with corporate and non-profit partners, teaching conferences, grand rounds, journal club, research seminars, and CME programs.

  • Works with Sponsored Projects Officer to manage program and project funds and dissemination of funding to collaborations sites in addition to the subcontracts with other sites.

  • Provides funding opportunity notifications to PI's.

  • Collaborates with department/center investigators in the development of IRB protocols, grant submissions and scientific publications.

  • Coordinates personnel needs for the program and projects; oversees and organizes training.

  • Track projects and initiatives to ensure they move forward based on both timelines and budget; report to PI when progress is lacking and identifies needed action.

  • May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.).

  • Manages and oversees IRB process for program projects and associated sites, ensuring sites are submitting accurate and timely IRB submissions, and maintain associated regulatory documents.

  • Helps facilitate creation of source documents that ensure systematic data collection and/or aid in protocol execution and management and record keeping.

  • Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects.

  • Provides monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations QA process implementation, maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols.

  • Work with principal investigators at each site to establish multi-site monitoring plans for investigator-initiated projects.

Qualifications

Knowledge, Skills & Abilities:

Education Requirement

Bachelor's degree preferred or Associates degree with two years clinical research experience or project management experience.

Certifications

ACRP or SOCRA certification preferred within 12 months of hire and maintained throughout employment.

Skills

  • Demonstrated leadership skills

  • Strong organizational skills

  • Exceptional interpersonal skills

  • Excellent written and verbal communication Ability to filter information, discern importance and initiate plan for project completion

  • Goal-oriented; self-directive

  • Initiation, flexibility, motivation, creativity

  • Ability to actively participate as a team player

  • Working knowledge of PCs and word processing and data management software

Experience

Two years clinical research experience or project management experience.

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 individual 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 his/her supervision.

EOE M/F/Disability/Vet

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Research Coordinator II Connect

Nationwide Children's Hospital

Posted 1 week ago

VIEW JOBS 6/17/2022 12:00:00 AM 2022-09-15T00:00 Overview Clinical Research Coordinator II - Connect The Clinical Research Coordinator II is responsible for managing all of the elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities. The CRC II also trains and mentors other CRC?s to ensure consistency in study management activities. Why Nationwide Children's Hospital? The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose. Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere. Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere. Nationwide Children's Hospital. A Place to Be Proud. Responsibilities PRINCIPAL DUTIES AND RESPONSIBILITIES * Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices. * Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects * rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate; * Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies * Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success * Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination. * Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection, * Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF?s) and ensures CRF?s are completed prior to monitor visits. * Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training. * Alerts the investigator when the subjects safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. * Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder. * Assists the principal investigator in the preparation of scientific publications and grant proposals. Qualifications Education: * BA/BS preferred; Associates degree or equivalent work-related experience required. Certifications: * CRA/CRC certification preferred. Skills: * Understanding of medical terminology and clinical trials preferred. * Working knowledge of PCs and word processing and data management software. * Demonstrated analytical skills with accuracy and attention to detail. * Excellent verbal and written communication skills * Goal-oriented and self-directive, ability to manage complex projects independently. * Strong organizational and interpersonal skills. * Ability to actively participate as a team player. Experience: * Minimum of 18 months experience in clinical research or health care field, two years preferred. * The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. * OCCASIONALLY 1-33% OF TIME (0.5 TO 2.5 HOURS) * Squat/kneelReaching above shoulder * Driving * Exposed to fumes/gases/vapors * Exposed to loud noises * Exposed to cold temperatures * FREQUENTLY 34-66% OF TIME (2.6 TO 5.0 HOURS) * Bend/twistStandingWalkingSittingLifting/carrying up to 50 lbs. may need assistance * Pushing/pulling up to 100 lbs. may need assistance * Exposed to blood and/or bodily fluids * Exposed to communicable diseases and/or pathogens * Exposed to chemicals/medicationsWork with patient equipment * Exposed to biohazard wasteWork with machinery * CONTINUOUSLY 67-100% OF TIME (5.1 TO 12 HOURS OR GREATER) * Flexing/extending of neck * Hand use: grasping, gripping, turning * Repetitive hand/arm use * Computer skills Audible speech * Hearing acuityDepth perception * Peripheral visionSeeing-far/near Problem solving * Decision making Interpreting data EOE/M/F/Disability/Vet. Nationwide Children's Hospital Columbus OH

Clinical Research Program Coordinator Non-Rn

Nationwide Children's Hospital