Clinical Data Coordinator

Purpose: Aerotek Scientific is looking for a Clinical Data Coordinator within the Pharmaceutical/Biotechnology industries.

Our client currently has 5-6 studies and is looking for someone with a lot of energy and interest in learning!

DESCRIPTION:

Position Description-

As a Clinical Data Coordinator, the successful applicant will support the Clinical Solutions Team in comprehensive data management and data quality control activities (including set-up, data validation, and data close-out) integral to the company's clinical development programs.
This position is full-time. (Part-time, contract, and contract-to-permanent candidates will be considered, depending upon experience.)
Position Responsibilities
-Successfully support the Clinical Solutions Practice Leader in the execution of clinical development programs in accordance with operating timelines, GCP-compliant Standard Operating Procedures, and other applicable SOPs and regulations
-Uphold processes that ensure the absolute integrity of clinical study data sets, analysis, and Clinical Study Reports
-Ensure accurate entry of clinical study data to maintain the absolute integrity of clinical study data sets
-Interface with and provide progress reports to clinical monitoring, medical affairs, database development, statistical, and program management staff
-Support the Clinical Solutions Team/Data Manager in the validation of clinical databases, including testing of logic checks
-Support the Clinical Solutions Team/Data Manager in the creation and production of Case Report Forms and data capture guidelines
-Comply with standard data management procedures and departmental operating procedures
-Log-in and track Case Report Forms
-Complete pre-entry review and data entry of clinical study data
-Assist the Clinical Data Manager in providing ongoing review of SAS tables and listings for accuracy and consistency
-Support the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, and other controlled documentation
-Develop and maintain a daily workplan and calendar that tracks activities, milestones, and deadlines
-Develop and maintain the requisite computer skills to effectively utilize state-of-the-art office equipment and systems, including database applications and applications for the development of Case Report Forms (Ongoing testing and certifications may be expected.)
-Maintain documentation, filing, tracking, and information retrieval systems
-Project a mature, professional image and provide responsive, high-quality follow-up to investigator and internal inquiries
-Assist the Clinical Data Manager in providing CDM support for team and clinical sites
-Understand and comply with Standard Operating Procedures and work instructions
-Perform other duties as may be assigned by the Clinical Data Manager, or senior management
-Report to the Clinical Data Manager

Position Qualifications-

-Minimum 6 months successful professional experience with leading biomedical industry firms in the medical device, pharmaceutical, and/or contract research industries biomedical or related industries (Entry level candidates will be considered, depending upon experience.)
-Successful, significant contributions to pharmaceutical and/or Class II and III medical device regulatory submissions and approvals a plus
-Documented proficiencies in harmonized GCP standards, the medical device product development and approval process, HIPAA, 21CFR Part 11, serious adverse event reporting and reconciliation, and related Standard Operating Procedures
-Documented, contemporary training in clinical data management (SCDM/ACRP/OCRA certifications in Clinical Data Management and Clinical Research a plus.)
-Documented proficiencies in the coding of medical terms, adverse events, and medications preferred
-Understanding of the medical product development process, the clinical research development process, the clinical data management process; physiology, pharmacology, clinical study objectives and methodologies; and the definition of SAEs and UADEs and how they apply to the review of clinical data
-Associate or Bachelor's degree or equivalent combination of education and experience, preferably in life sciences, biomedical, or clinical fields. (Candidates with vocational training will be considered, depending upon experience.)
-Strong proficiency in Microsoft Windows and Office applications required
-Must be willing to relocate to the Boston area permanently, for up to 2 years
-Excellent presentation and communication (both oral and written) skills
-Excellent time management, planning, and teamwork skills
-Must be willing to work hours as needed to meet deadlines and needs


If you are interested in applying for this position please contact Andrea Chruney at (781)356-6916 or send your resume and references to