RESEARCH COORDINATOR II (IRB)
Location: Maryland
Description: Clinical Trials Center is at present looking to employ RESEARCH COORDINATOR II (IRB) right now, this career will be placed in Maryland. For detail informations about this career opportunity kindly see the descriptions. JOB ID 30104
In accordance with the needs of the ages of the population served by KKI, and as an active member of the Clinical Trials Unit (CTU), the Research Coordinator ! (IRB) is responsible for overall IRB compliance and insuring the timeliness submission, processing and accuracy of new IRBs protocols and any associated addendums as it relates to current, pending and future clinical trials within the Clinical Trials Unit. This position is the primary point of contact for CTU PI’s, team members and collaborators related to IRB compliance.
Responsibilities:
Primary oversight and responsibility for the preparation and submission of all Clinical Trials Unit IRB protocols through the Johns Hopkins IRB system through the portal of the eIRB.
Responsible for gathering and analyzing relevant IRB protocols and related data. Insures compliance standards are met and solves problems by communicating effectively and utilizing resources to submit, resubmit and revised IRB protocols as required.
Establishes strong working relationships with JHU IRB representatives and collaborates with JHU IRB representatives to address conce! rns, questions and issues that arise during the IRB review pro! cess. Seeks out information and obtains input from medical leadership as required.
Responsible for developing efficient standards of communication and IRB business process workflow between the CTU team, the JHU IRB representatives, the IRB review board, and other collaborators as needed. This includes but is not limited to a) completing the informed consent process b) completing and developing the recruitment plans c) protocol development d) protocol deviations and e) all other IRB related matters of significance.
Reviewing and resolving for consistency between what is stated in the Sponsor’s agreement and consent as compared to the JHMIRB approved protocol and consent.
Completing documentation associated with changes in research including changes in study team membership, changes in targeted recruitment, and changes made by the Sponsor.
Managing continuing review process, this includes review of study progress, current enrollment, protocol deviations, pub! lications associated with study, explain withdraw or termination, missed visits, etc.
Assisting medical leadership with the protocol development of Investigator initiated studies.
Coordinating with the Clinical Trials Nurse, report adverse events to the JHU IRB.
Participating in internal IRB audits, which include presenting all related study documentation.
Responsible for staying up to date with current IRB processes, guidelines and standards. Ensures all study team members have current IRB training and keep current certificates on file.
Assisting the Clinical Trial Coordinators to gather necessary documents and signatures during the initial contact and discovery process with the Sponsor(s). This may include but is not limited to CVs, medical licenses, completion of the 1572 form, etc.
Qualifications:
EDUCATION:
BS/BA in related field of science or public health required.
MS preferred.
EXPERIENCE:
At! least 2 years’ experience years of clinical research monitoring expe! rience (including pre-study, initiation, routine monitoring and closeout visits)
One year of monitoring or administering complex clinical trials.
Equivalent combination of education and experience may be considered.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Clinical Trials Center.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Tue, 02 Apr 2013 21:40:28 GMT