Senior Data Coordinator

CliniLabs Inc. New York, NY

Job Title - Senior Data Coordinator

Job Number - CL-Job-151

Date Prepared – 24 Sep 2014

Department – Data Services

FLSA Status – Non-exempt

JOB SUMMARY

The Senior Data Coordinator manages core lab data (e.g. PSG, ECG, etc.) relating to various studies.

REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES

* The position requires at least 3 years of experience in a Data Coordinator role and/or comparable roles. A bachelor's degree is strongly preferred.

* Strong computer (Microsoft Windows and Office Applications) and communication (oral and written) skills are required.

* Must have detailed documentation and project management skills.

RESPONSIBILITIES

* Serve as the core lab Data Coordinator on studies

* Provide leadership and guidance to Data Coordinators

* Create training & delegation of responsibilities documents for support staff

* Provide support and act as the point person to the Sponsor, CROs, vendors, clinical sites, and scorers for questions regarding core lab data management

* Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members

* Manage and track project timelines and quality issues

* Develop presentations and present at Investigator meetings

* Develop study-specific SOPs

* Assist in with certifying (e.g. PSG certification) study sites

* Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol

* Monitor and update study database to ensure that all data is being processed in a timely manner

* Perform data entry and data QC

* Perform query generation and tracking and oversee query resolution

* Create a study-specific regulatory binder and screening binders, where applicable.

* File and store documents according to protocol

* Track study progress and issue periodic status reports as needed

* Assist in the creation and documentation of new or revised data management, IT and quality assurance procedures

* Communicate with all operational departments regarding project status/issues

* Follow and ensure compliance with current Good Clinical Practices (cGCPs)

* Adhere to corporate policies and procedures

* Other duties as assigned

TRAVELING

Between Corporate New York site and New Jersey sites, as needed.