DIRECTOR OF CLINICAL RESEARCH - ADMINISTRATION
EAMC MISSIONAt East Alabama Medical Center, our mission is high quality, compassionate health care, and that statement guides everything we do.
We set high standards for customer service, quality, and keeping costs under control.
Essential Job Functions:
Adheres to GCP, FDA , and Organization guidelines when implementing research trials to ensure highest quality research within Organization.
Ensures patient eligibility in research study, all protocol procedures and data collected are completed per protocol.
Ensures all documentation is completed to ensure high quality of research and sponsor satisfaction.
Coordinates and prioritize multiple clinical trials to ensure production in the Institute of Research and Education.
Works in a collaborative manner with research staff in order to meet research objectives of the team.
Has detailed knowledge of all components of the research study protocol by creation of study packets, in servicing hospital staff and departments, and completion of all regulatory documents complete.
Ensures all regulatory documents are complete and submitted to Institutional Review Board and study sponsor prior to any research activities being initiated.
Identifies prospective research patients by rounding and screening appropriate areas demonstrated by screening logs and enrollment handed in weekly to sponsor and management coordinator.
Recognizes and interprets diagnostic, physical and psychological findings and incorporates these findings to determine patient eligibility in study as demonstrated by appropriate patients enrolled in studies and no protocol deviations identified by sponsors.
Completes all procedures identified by protocol demonstrated by no protocol violations from the sponsor and quality review tool by Institute of Research and Education staff.
All data points and case reports forms are completed with in 4 weeks of patient enrollment or study visit.
All Institutional Review Board documentation and notifications of AE, SAE amendments and continual reviews are reported to Institutional Review Board per Institute of Research and Education/Institutional Review Board SOP's.
Manage multiple clinical trials.
Maintains study enrollment as measured by 75% enrollment rate.
Assist, volunteers and communicates with peers for 24 hour coverage of all research protocols.
Serves on one unit or hospital committee as requested.
Attends 90% of weekly team meetings and 90% of all staff meetings.
Completes weekly tracking sheets.
Role Requirements:
Minimum Education Bachelor's Degree.
Minimum Experience Minimum 5 years clinical research experience Required Registration/License/Certification Obtain and pass CRC req's after 2 years (and with required number of hours worked in the research field) of Organization's Research experience.
Registered Nursing License; ACRP Recommended Skills Clinical Research Clinical Trials Nursing Psychology Research Experiences Research Estimated Salary: $20 to $28 per hour based on qualifications.
We set high standards for customer service, quality, and keeping costs under control.
Essential Job Functions:
Adheres to GCP, FDA , and Organization guidelines when implementing research trials to ensure highest quality research within Organization.
Ensures patient eligibility in research study, all protocol procedures and data collected are completed per protocol.
Ensures all documentation is completed to ensure high quality of research and sponsor satisfaction.
Coordinates and prioritize multiple clinical trials to ensure production in the Institute of Research and Education.
Works in a collaborative manner with research staff in order to meet research objectives of the team.
Has detailed knowledge of all components of the research study protocol by creation of study packets, in servicing hospital staff and departments, and completion of all regulatory documents complete.
Ensures all regulatory documents are complete and submitted to Institutional Review Board and study sponsor prior to any research activities being initiated.
Identifies prospective research patients by rounding and screening appropriate areas demonstrated by screening logs and enrollment handed in weekly to sponsor and management coordinator.
Recognizes and interprets diagnostic, physical and psychological findings and incorporates these findings to determine patient eligibility in study as demonstrated by appropriate patients enrolled in studies and no protocol deviations identified by sponsors.
Completes all procedures identified by protocol demonstrated by no protocol violations from the sponsor and quality review tool by Institute of Research and Education staff.
All data points and case reports forms are completed with in 4 weeks of patient enrollment or study visit.
All Institutional Review Board documentation and notifications of AE, SAE amendments and continual reviews are reported to Institutional Review Board per Institute of Research and Education/Institutional Review Board SOP's.
Manage multiple clinical trials.
Maintains study enrollment as measured by 75% enrollment rate.
Assist, volunteers and communicates with peers for 24 hour coverage of all research protocols.
Serves on one unit or hospital committee as requested.
Attends 90% of weekly team meetings and 90% of all staff meetings.
Completes weekly tracking sheets.
Role Requirements:
Minimum Education Bachelor's Degree.
Minimum Experience Minimum 5 years clinical research experience Required Registration/License/Certification Obtain and pass CRC req's after 2 years (and with required number of hours worked in the research field) of Organization's Research experience.
Registered Nursing License; ACRP Recommended Skills Clinical Research Clinical Trials Nursing Psychology Research Experiences Research Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
