CLINICAL TRIAL PROTOCOL COORDINATOR (2 TARGET OPENINGS) / 40 HOURS / DAY / BWH - TIMI 9/15/2016
Brigham & Women's Hospital(BWH)
JOB DESCRIPTIONAPPLY GENERAL SUMMARY/OVERVIEW STATEMENT:
Working independently and under general supervision, the Clinical Trial Protocol Coordinator will support their department/trial(s) in the administrative day to day project activities of TIMI trials (both nationally and internationally) following good clinical practices, regulatory requirements and sponsors/TIMI standards to ensure compliance for the TIMI Study Group.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
* Advise sites on protocol conduct, interpretation of protocols and ensures resolution of issues as applicable per department/trial. Coordinators are expected to manage higher and/or more complex site loads.
* Identify and initiate communications with sites to obtain all relevant documents for department/trial.
* Evaluate the quality of data, issue, track and resolve queries, implement corrective action plans.
* Update and maintain internal databases, tracking systems and project plans with department/trial specific information.
* Prepare presentation materials for meetings (internal/external)
* Facilitate the implementation and ongoing process improvement of established policies and procedures for department trial. Comply with applicable SOPs.
* Work with Project Manager to support trial processes and distribution of information/reports to monitors in both North America and internationally.
* Identify issues/trends that require management escalation and provide input to resolution as appropriate.
* Maintain department service standards, with particular attention to person/behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the BWH Code of Conduct.
* Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trial(s).
* Performs other tasks and responsibilities as directed.
* Bachelors degree and 1 to 2 research related work experience
* Familiarity with EDC and CTMS systems preferred
* Demonstrated high level proficiency in MS Office products (Word and Excel) and familiarity with databases
* Preferred but not required proficiency in Adobe Acrobat applications
* Detail oriented
* Customer service oriented
* Strong organizational skills
* Strong sense of accountability and an ability to work autonomously, as well as act as a strong team player
* Ability to communicate effectively in a matrix environment
* Solid written and verbal communication skills
* Ability to manage multiple tasks concurrently
* Ability to demonstrate professionalism
* Ability to work independently
* Knowledge of clinical research protocols
Busy office environment with frequent deadlines
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.
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