PRN Data Coordinator

SUMMARY: The PRN Data Coordinator, is responsible for assuring that the source data captured during a clinical trial has been transcribed into the Case Report Form (CRF) with accuracy and that the data transcription has been completed in accordance with Good Clinical Practice guidelines. The PRN Data Coordinator works under the general supervision and guidance of the Senior Manager, Study Conduct.

RESPONSIBILITIES:
Tasks may include but are not limited to:

Reviews study protocol for studies assigned.
Ensures data from source documents for the trial are accurately reflected on the Case Report Form whether electronic or paper.
Keeps track of source documents being filed into subject folders.
Assistance with reconciliation of study records for archive.
Identifies problems or potential problems and reports them to his/her supervisor.
Responsible for requesting, scheduling and attending any training required for this position.
Responsible for completing all necessary training, including SOPs and WIs.
Always representing Worldwide Clinical Trials (WCT) in a professional manner (verbal, written, and in appearance) when interacting with sponsors, volunteers, outside vendors, and fellow employees.
Follows WCT safety guidelines.
Performs miscellaneous duties as assigned.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

Excellent written and oral communication skills.
Ability to understand complex written and oral instructions.
Basic computer knowledge and applications required for generation of business correspondence and entry of study data into an electronic Case Report Form. Strong interpersonal skills. Excellent attention to detail.
Exceptional organizational skills. Ability to set and meet deadlines with high quality work.
Some knowledge of the clinical research process, including Good Clinical Practices.
Possible equipment includes, but is not limited to: computers, rolling carts, fax machines, photocopiers, telephone, mop/broom.
Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, client contact, close attention to detail, multiple tasks, and fluctuation in work load.
Possible physical demands include but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
REQUIREMENTS:

Required: Bachelor’s Degree or Associates Degree (preferably in the field of Life Sciences or Health), and/or experience in a phase I clinical environment.
Preferred: Experience or class work in the health field.
Other:
There will be times when an adjustment in work hours to include weekends is necessary.
Responsible for planning and managing his/her daily workload with the ultimate goal of meeting set study timelines.
This person must be self-motivated and able to manage multiple tasks and deadlines, to ensure that all deadlines are met.
Must be able to follow written and verbal communication.
Must be punctual.
The PRN Data Coordinator will have contact with internal staff and occasionally with Sponsors. Professionalism and customer service will be of the utmost importance as a representative of WCT.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work