Data Compliance Coordinator

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose: Under the general direction of the Research Team Leader, the Research Team CDA is responsible for the successful completion and filing of case report forms and source documents for clinical research studies. Works with sponsor representatives at all meetings/visits when case report form data is reviewed. Ensures all subject data is boxed as required for study archiving.

Essential Functions and Other Job Information:

Essential Functions  Develops filing system for each study, to ensure each subject folder will be accessible to others if necessary. Ensures each folder is eventually complete and orderly with all required forms completed and audited for accuracy. Flags any discrepancies in data to be resolved by appropriate staff. Ensures proper documentation to the study file addressing any study issues so all aspects of the study are clear even years after study is completed.  Reviews protocol and case report forms (CRFs) to determine study specific information. Evaluates for gaps in information and discuss omissions with Team Leader and Project Manager to develop clear criteria for case report form completion.  Ensures accurate and timely completion of study CRFs to meet sponsor requirements and deadlines. Informs Research Team Leader and Project Manager of any issues/problems, which may cause delays.  Ensures principal investigator signs all CRFs and is apprised of any data issues on the study.  Ensure all study participants’ paperwork is complete and adequately reflects participation in the study as per FDA requirements. Boxes completed study information in accordance with the clinical archival process. Resolves any sponsor queries after the study has been completed.  Ensures all case report forms and subject folders are reviewed by QA prior to review by sponsor or signature by PI.  Sets up sponsor rooms prior to sponsor visit.

Job Complexity Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

Job Knowledge Applies acquired job skills and company policies and procedures to complete assigned tasks.

Supervision Received Normally follows established procedures on routine work, requires instructions only on new assignments.

Business Relationships Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Qualifications:

Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience. Bachelors Degree preferred. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:  Demonstrated ability managing multiple responsibilities and completion of projects in either a work or school setting.  Basic computer skills including knowledge of Microsoft Office and the ability to learn various programs and/or systems such as the Oracle database.  Strong communication skills. Ability to clearly explain information to a wide variety of individuals.  Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings.  Strong attention to detail.  Strong planning and organization capabilities to manage multiple tasks and multiple study groups at one time.  Effective time-management skills.  Strong auditing and documenting skills.  Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically or other approved dosing methods.

Management Role: No management responsibility

Working Conditions and Environment:  Work is performed in an office or clinical environment with exposure to electrical office equipment.  Occasional drives to site locations. Potential Occasional travel required.  Frequent long hours, weekends and/or holidays  Exposure to blood and biohazardous waste  Be available by cell phone after hours  Exposure to fluctuating and/or extreme temperatures on rare occasions

Physical Requirements:  Frequently stationary for 2-4 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. 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.  May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.  Works with guidance or reliance on oral or written instructions from management. May require 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.