Clinical Data Coordinators

CLINICAL DATA COORDINATOR

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client partners with pharmaceutical, medical device and biotech companies alike to help get new, groundbreaking products approved and to market faster and is seeking to add a Clinical Data Coordinator to their team in Media, Pennsylvania.

 

JOB SUMMARY:

The Clinical Data Coordinator (CDC) works as a member of the Data Management Team to assure the quality of clinical study data.  Works under the direction of a Clinical Data Manager and supervises data entry staff.  The CDC may be responsible for coordinating data processes related to more than one clinical study.

 

RESPONSIBILITIES:

- Assists in preparation of study operations manuals, CRF completion instructions, and study binders as requested

- Assists in study file set-up and maintenance, coordination of CRF printing, and assist Clinical Data Manager as assigned.

- Assists with review and evaluation of protocol against Case Report Forms (CRFs).

- Report findings to senior staff to assure consistency and quality of study data.

- Prepares portions of the Data Management Plan according to agreed upon study processes, under supervision of the Clinical Data Manager.

- Participates in testing and validation of study-specific data entry systems.

- Reviews and prepares CRFs and other study data for data entry.

- Manages accurate data entry.

- Train data entry personnel in study-specific data entry system.

- Review dual key comparison results and resolve discrepancies against CRF source.

- Monitor data entry quality and report status of data entry processes and error rates.

- Performs data validation using an automated query management system.

- Logs and tracks queries in the query management system and oversee query resolution working with Company or Sponsor monitors and study site personnel, as appropriate to study-specific work processes.

- Enters changes and updates to the study database based on query resolution.

- Specifies and reviews data listings to identify data quality issues or to validate table contents

- Participates in the quality control review of data prior to study release.

- Trains, manages and provides feedback on performance and development of data entry staff

- Attends and contributes to company in-service programs related to professional development

- Communicates effectively and objectively

- Provides constructive, collaborative comments and feedback

- Organizes, participates in and facilitates internal meetings

- Maintains electronic files that can be accessed by appropriate personnel

- Uses applicable systems to communicate with personnel.

- Demonstrates vision, passion, and commitment to company goals and objectives

- Demonstrates professionalism and integrity in all work-related interactions

- Participates in staff and departmental meetings

- Supports all company departments as necessary

- Maintains a high level of professionalism, performance, productivity and quality amidst the pressure of project deadlines and priorities

- Initiates conflict resolution with other team members both internally and externally

- Complies with corporate policies and procedures.

 

QUALIFICATIONS:

- Minimum of three years of data management/coordinator experience.

- Two or more years of experience in the clinical research environment preferred (pharmaceutical, biotechnology or academic).

- Must be knowledgeable regarding database audits, discrepancy review, query generation and resolution.

- Must be familiar with medical terminology.

- Must be very flexible and adjust well to changing priorities and new projects.

- Should have a working familiarity with drug and/or medical device industry, US federal regulations, ICH Guidelines, HIPAA and GCP.

- Ability to program in SQL and/or SAS is a major plus.

- Excellent communication and organizational skills.

- Committed to quality and excellence.

- Computer proficiency, including use of standard software (word processing, spreadsheet, graphics, databases and e-mail) and use of the Internet.  Experience with Microsoft Access, MS Project, MS Word, MS Excel and MS PowerPoint preferred.

- Self-starter with good time management and problem-solving skills.

 

EDUCATION:

- Bachelor's degree required. Academic background in a Biological Science, Computer Sciences, Pharmacy, or Allied Health Profession preferred.

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.