Data Coordinator - Full Time
Position Summary: The Data Coordinator (DC) works closely with the Sponsor/CRO, investigator, research coordinators and appropriate staff in each department of West Clinic including regulatory, project management, quality assurance and statisticians. The DC will complete a case report form (CRF) for each subject using source documents scanned or through direct access to a sites EMR. The DC is responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts. Work is performed under the general direction of the Senior Manager, Research Services.
Essential Duties and Responsibilities:
- Responsible for site data management of all West Clinic study subjects
- Completes CRF (both electronic and paper) using source documents scanned or through direct access to the EMR
- Generates site queries for missing information and communicates with site personnel to resolve both internal and external queries; will query the site every 7 days until the queries are resolved
- Schedules and directs sponsor monitoring visits
- Reviews and evaluates the quality of CRF completions prior to monitoring visit to ensure that data is accurate and current
- Communicates with site personnel to resolve any outstanding issues from the previous monitoring visit prior to upcoming monitoring visits
- Meets with monitor during the visit to complete CRF corrections
- Maintains subject screening/enrollment logs as directed by each study team
- Prepares for any study audits that might be conducted
- Acts as a liaison between coordinator, monitor and regulatory affairs
- Attends investigator meetings as needed
- Coordinates and participates in internal and external meetings as needed
- Participates in departmental meetings with project management and regulatory departments.
- Participates in sponsor/CRO visits
- Develops timelines based on project priority list
- Maintains a professional approach respecting the dignity and confidentiality of employees, managers, and vendors
- Interfaces internally with fellow Site Data Services staff, Project Management, Regulatory Affairs and Contracts/Budgeting personnel
- Interfaces externally with participating sites, Sponsors and CROs
- Performs all other duties as assigned
Qualifications/Experience:
Bachelor’s degree from four-year college or university; OR three years related experience and/or training in healthcare and/or clinical research environment; OR equivalent combination of education and experience which enables one to perform the essential job functions. Medical terminology and health information management experience preferred.
Required Knowledge, Skills, and Abilities
- Must have good communication skills in both verbal and written form
- Must have excellent organizational and time management skills
- Must have good computer skills to include Word and Excel
- Must be able to read and understand medical documents such as physician notes, nurse’s notes, treatment records, pathology and radiology reports and protocols
- Must be able to prioritize multiple projects and coordinate these efforts
- Must be able to maintain confidentiality of information and procedures developed
- Must be able to promote a positive customer service attitude with sponsor/CRO and maintain positive working relationships with internal and external staff (team player)
- Must be self-motivated
- Must be detail oriented
- Must maintain overall professionalism
- Must have an understanding of GCP/ICH guidelines and FDA regulatory requirements
- Ability to read, analyze, and interpret source documentation, protocols, and case report forms. Ability to write report and business correspondence. Ability to effectively present information and respond to questions from groups or managers, clients, and customers.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, fractions, and decimals. Ability to compute rate, ration, and percent and to interpret bar graphs.
- Ability to apply common sense understanding to carry out instructions given in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in routine situations.
- Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see, and hear for extended periods of time
- Ability to lift up to 25 lbs.
- Travel may be required
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