Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Ensures the quality and integrity of data and information by conducting timely and cost effective audits of diverse scope against customer, sponsor, PPD and regulatory requirements and specifications. May provide review services for CDS, Biostatistics and Data Management, Regulatory Affairs, Phase I, or any other PPD department as requested.

This position is a part time position working 20 hours per week

Day to day responsibilities:

• Conducts document reviews which may include, but not be limited to reviews of protocol, case report forms, case report form guide, investigator's brochure, investigator files, monthly reports, clinical/statistical reports, Phase I reports, statistical reports, abstracts, manuscripts, or miscellaneous study tools) that concentrate on key measures, operational standards, and sponsor requirements to ensure accuracy, consistency, and integrity of data/information

• Conducts reviews of subject source data prior to enrollment and subject source data/CRF entry prior to database lock to archive submission to ensure completeness and accuracy of files

• Prepares written audit reports that accurately describe audit findings

• Communicates specific findings, questions and/or concerns in a timely fashion. Maintains audit trail of decisions or changes.

• Interacts with PM when needed to effectively communicate QC project needs, problems, and timeframes for completion. Participates in team meetings, as requested

• Assists in the development/revision of procedural documents, as appropriate

• Provides resource/training for team members and/or personnel in the QC process

• Performs other job related duties as assigned

Qualifications:

• Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Working knowledge of FDA regulations and guidelines, Good Clinical Practices, and PPD SOPs/Working Practice Documents

• Computer skills including Microsoft Office and database entry

• Must have the ability to analyze and interpret data

• Detail oriented

• Independent judgment and good decision making capabilities

• Good oral and written communication skills

• Good interpersonal skills

• Must be able to function in the role of mentor/trainer for ongoing process improvement issues with the study teams

• Time management and project management skills

• Ability to work in a collaborative team environment

Working Conditions and Environment:

Work is performed in an office environment with exposure to electrical office equipment.

Physical Requirements:

• Frequently stationary for 6-8 hours per day

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists

• Frequent mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.

• Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

• Ability to perform under stress.

• Ability to multi-task.

• Regular and consistent attendance