clinical research coordinator benefits

• Clinical Research Coordinator Roles and Responsibilities

Position Role Sponsored Program Administration Financial Management Effort Reporting Conflicts of Interest Human Research Participant Protection Environmental Health and Safety Human Gene Transfer Export Controls

Position Role

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.

Sponsored Program Administration

General administrative.

• Coordinates with Principal Investigator 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 (but not limited 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.
• 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.
• 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.

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 & Review

• 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. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.

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. Documents date of training and signatures of study personnel trained on study specific training log.
• 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 HRPO (IRB) requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the HRPO (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).
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
• 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. If handling investigational drugs/devices, follows the sponsor protocol and/or Washington University Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, 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.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.

Project Closeout

• Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, university entities, 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.

Financial Management

• 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 (if applicable) 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.

Conflicts of Interest

• Takes appropriate steps to avoid conflicts of interest, or the appearance of conflicts of interest, between financial or other personal interests and the goals and policies of the university.
• Complies with applicable school, university, and sponsoring agency conflict of interest policies and procedures. Discloses all financial conflicts of interest to the appropriate supervisor.
• Cooperates with university compliance and monitoring efforts related to conflicts of interest and reports instances of noncompliance to the appropriate compliance office.

Human Research Participant Protection

• 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 in accordance with federal regulations and university and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator 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 (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• 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.
• 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. These study materials include but are not limited to the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

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.
• Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Conducts or participates in the informed consent process including interactions with the HRPO (IRB), discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• Retains all study records in accordance with sponsor requirements and University policies and procedures.
• Assists PI in preparation and submission of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.

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.

Unanticipated Problems

• Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the HRPO (Washington University’s IRB).
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
• Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.

Environmental Health and Safety

• Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety training in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Works with Environmental Health and Safety to ensure that all facilities used are in compliance with all applicable regulations. Maintains copies of any applicable facility audits and equipment inspection/service reports.

Human Gene Transfer

• 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 in accordance with Federal regulations and University and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator 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 (but not limited to)  protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• 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.
• 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.
• 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. These study materials include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Engages participants in the informed consent process according to the HRPO approved process.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions.  Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor and/or Washington University Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and university policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• 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.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Export Controls

• Develops awareness of export control regulations and complies as appropriate.

Revised January 2009 | Created 2007

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