CLINICAL RESEARCH COORDINATOR Dr D Rispa Assistant Professor

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CLINICAL RESEARCH COORDINATOR Dr. D. Rispa Assistant Professor Pharmacy Practice Department

CLINICAL RESEARCH COORDINATOR Dr. D. Rispa Assistant Professor Pharmacy Practice Department

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). PI design conduct management of clinical trial. CRC supports facilitates coordinates clinical trial activities. CRC + PI + department + sponsors + institution support and provide guidance of compliance, financial, personnel and other aspects.

 • General Administrative • Collaborates with PI and institution to respond to any

• General Administrative • Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. • Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.

 • Coordinates with PI and school, department, and central administration to help ensure

• Coordinates with PI and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to protocol requirements, schedule of visits, execution of research plan. • Maintains documentation of training. • Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

 • conduct clinical trials in the medical world. • responsible for ensuring these

• conduct clinical trials in the medical world. • responsible for ensuring these trials are conducted in an ethical manner, using what is referred to as good clinical practice. • Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. • Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.

Preparation of Scientific Proposal • Assists the PI in study feasibility assessments as requested.

Preparation of Scientific Proposal • Assists the PI in study feasibility assessments as requested. Proposal Budget Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.

Protocol Preparation & Reviews and comprehends the protocol. Attends investigator meetings as required or

Protocol Preparation & Reviews and comprehends the protocol. Attends investigator meetings as required or requested by the PI. Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. materials include, informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Establishes and organizes study files, regulatory binders, study specific source documentation and other materials.

Conduct of Research: • Reviews and develops a familiarity with the protocol, e. g.

Conduct of Research: • Reviews and develops a familiarity with the protocol, e. g. , study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. • Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members • Collects documents needed to initiate the study and submit to the sponsor (e. g. , FDA Forms 1572, CVs, etc. ). • Works with the PI to develop and implement recruitment strategies in accordance with (IRB) requirements and approvals.

 • Conducts or participates in the informed consent process including interactions with the

• Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. • Assures that amended consent forms are appropriately implemented and signed. • Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. • Registers participants to the appropriate coordinating center (if multi-site study). • Coordinates participant tests and procedures. • Collects data as required by the protocol. • Assures timely completion of Case Report Forms. • Maintains study timelines.

 • Maintains adequate inventory of study supplies. • Completes study documentation and maintains

• Maintains adequate inventory of study supplies. • Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. • Retains all study records in accordance with sponsor requirements and University policies and procedures. • Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. • Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.

Financial Management General Administrative Reviews and accepts/corrects the billing matrix as set up by

Financial Management General Administrative Reviews and accepts/corrects the billing matrix as set up by the Center for Applied Research Science (CARS) to facilitate billing of study procedures to the appropriate research fund. Coordinates appropriate and timely payments to participants in accordance with University policies and procedures. Effort Reporting Reviews, adjusts and legally certifies personnel activity reports if applicable. Completes effort reporting certification within the timeframe specified by Sponsored Project Accounting.

Human Research Participant Protection General Administrative • Assists Principal Investigator in protection of the

Human Research Participant Protection General Administrative • Assists Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants. • Maintains proof of all such education for all engaged members of the study team • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.

 • Assists Principal Investigator to assure that all key personnel or persons ‘engaged’

• Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors. • Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.

Informed Consent • Assists in preparation of all documents related to the informed consent

Informed Consent • Assists in preparation of all documents related to the informed consent process. • Assists Principal Investigator in preparation and submission of informed consent documents to HRPO for review and approval.

CONFLICTS OF INTEREST: • Takes appropriate steps to avoid conflicts of interest, or the

CONFLICTS OF INTEREST: • Takes appropriate steps to avoid conflicts of interest, or the appearance , between the financial or other personal interest and the goals and policies of sponsors. • Compliances with applicable school or sponsoring agency conflict of interest policies and procedure. • Cooperates and monitors effects related to conflicts of interest and reports instances of non compliance to appropriate compliance office • Promotes ethical conduct of research by reporting good faith suspicious od misconduct in research as defined within Policy. • Assists PI with scientific and compliance reporting requirements in accordance with federal regulations and agency policies. • Assists in regulation of the study at clinicaltrial. gov and maintains current information on the site.

Protected Health Information • Adheres to and supports all Federal regulations and University policies

Protected Health Information • Adheres to and supports all Federal regulations and University policies and procedures instituted to safeguard protected health information (PHI). • Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Assists PI to assure that all personnel complete appropriate training. • Cooperates with University compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Reporting • Promotes the ethical conduct of research by reporting good faith suspicions of

Reporting • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research. • Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Project Closeout • Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, University, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.