Laboratory Coordinator - Research Specialist II, Cardiology/Neuroscience
Posted 28 Feb 2019
Medical University of South Carolina
Charleston, South Carolina
Federica del Monte
Thirty-five percent: Responsible for reporting and communications with the IRB and study sponsors regarding adverse events, protocol deviations, study renewal, study termination, study amendments, and other activities necessary for regulatory compliance. Maintains regulatory documents as required by protocol regulations and policies; prepares and submits to sponsor requested regulatory documents, training documents and other required documentation; develops recruitment strategies and tools and identifies barriers to recruitment; develops recruitment plan in compliance with GCP guidelines, federal regulations and institutional policies.
Twenty percent: Perform complex molecular biology techniques under BSL1 and 2 safety guidelines.
Fifteen percent: Manages site-readiness activities; coordinates site-monitoring visits; conducts site-initiation, interim and close-out monitoring visits and writes reports and develops corrective action plans related to visit findings; identifies data discrepancies and protocol non-adherence issues, generates and reconciles queries; performs more complex assessments requiring training or certification, collects complex data from medical records.
Ten percent: Performs statistical analysis, and data preparation. Performs image analysis and professional-grade presentations for utilization in published work.
Ten percent: Performs routine maintenance on equipment, orders and maintain stocks of laboratory supplies and equipment.
Ten percent: Participates in and cooperates with external and internal audits; responsible for resolving issues; helps train staff on job related tasks; acts as liaison between sponsor and PI.
Applicant must effectively implement OSHA/IBC/IACUC/IRB regulations within the laboratory setting. Must be able to perform advanced immunological assays, tissue culture, molecular biology techniques. Must be comfortable training, supervising and directing students, graduate students and other employees. Individual must also be able to develop new research protocols and procedures while maintaining quality control of laboratory work.
MINIMUM REQUIREMENTS OF THE POSITION (Must at least meet the MUSC minimum requirements, but may include departmental preferences relevant to the position):
A master’s degree in biological or/and clinical science research or pharmacology.
Required certifications include CITI certifications in BioMedical Research and Good Clinical Practice (GCP), CCRP certification, and shipping hazardous materials.
Demonstrated advance level knowledge of research best practices.
Trains and acts as a resource on job-related tasks and research best practices.
Individual should be self-directed, self-motivated and able to work with minimal supervision. Excellent communication and research skills are necessary for this position.
Must have strong computer skills (EPIC, Word, Excel, database software, web-based activities, email). Knowledge of MUSC IRB, ORSP, and OCR policies/procedures is necessary.