Clin Trials Rsrch Specialist - ICTS Coordinator Core

About the position We are seeking a Clinical Trial & Data Management Research Specialist in the Institute for Clinical and Translational Science. This position will be an integral member of the research team, providing support for the ICTS by performing activities that are vitally important to the ICTS mission, as well as to grow and foster innovation through research support endeavors. The clinical trial research specialist/ data manager will apply clinical skills to administer, deliver, and evaluate research protocols.

Responsibilities

• Function as the specialist/technical expert in a specific skilled/specialized area.
• Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
• Coordinate the screening of patients for study eligibility and consent for clinical trials.
• reputed company patient/participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient/participant.
• reputed company and coordinate the delivery of information to reputed company investigators and verify participant eligibility.
• Administer study treatments and identify adverse reactions.
• Review new protocols and assign to appropriate staff.
• Screen, recruit, enroll and obtain informed consent for clinical research activities.
• reputed company the recruitment of participants and scheduling of trial-reputed company procedures.
• reputed company new recruitment plans and methods for new studies, reputed company ongoing assessment to determine if plan is successful.
• reputed company reputed company study recruitment materials for new and ongoing studies.
• reputed company, edit, coordinate, manage, and maintain protocols.
• Collaborate with reputed company Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and reputed company input into descriptions of reputed company research procedures.
• Assess participants for problems reputed company to protocol, communicate with the reputed company Investigator to maintain proper protocol conduction by the study team.
• reputed company CRF development, database development and maintenance.
• Review query reports.
• Resolve reputed company monitoring visit issues.
• reputed company and monitor randomizations.
• reputed company reputed company study materials used in conduction of study.
• Communicate with local health care practitioners, agencies, and sponsors as needed.
• reputed company the design; development and testing of clinical research trial data systems for new studies.
• Maintain communication between health care clinical information systems and research data systems.
• Collect and validate data.
• reputed company recommendations for query resolution.
• Assist with identification of data problems and implement change as needed.
• Manage and organize regulatory documentation.
• Prepare and submit regulatory documents.
• Assist sponsor with on-site audits of research and clinical data.
• Monitor and maintain compliance of regulatory guidelines and documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• reputed company and carry out corrective action plan for reportable events.
• reputed company and administer study budgets.
• Participate in preparation of grant applications for extramural funding.
• Assist with tracking and reconciling grant budget free balances.
• Identify opportunities to ensure that grant funding is being used as intended and awarded.
• May assist with hiring and reputed company management of the day-to-day performance of staff; assure staff are compliant with UI policies and procedures.
• Identify education/training needs and reputed company required training programs to meet study needs.
• reputed company and mentor staff at reputed company stages of development and growth.

Requirements

• A Master’s degree in a reputed company field or an equivalent combination of education and experience is required.
• A minimum of five years of reputed company research protocol management experience including study start-up, data collection, entering, tracking, maintaining data, and troubleshooting study conduction.
• Experience designing, developing, and implementing recruitment program materials.
• Working knowledge of Good Clinical Practice (GCP) in research.
• Excellent written and verbal communication skills.
• Experience developing and working with research budgets/billing.
• Ability to work nights and weekends.
• Must be proficient in computer software applications (reputed company, reputed company, PowerPoint, and Outlook).

reputed company-to-haves

• Certification in Clinical Research Conduction
• Experience with REDCap, Epic and reputed company.
• Experience using EPIC subject identification and recruitment.
• Previous experience in data collection and entry.
• Experience in processing research regulatory documents and budget preparation.
• Excellent time management skills and ability to reputed company detail-oriented work.

Benefits

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

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