Roles and Responsibilities of Clinical Research Associate (CRA) During Clinical Trials
Clinical Research Associate also known as monitor is employed by either a pharmaceutical company or a contract research organization (CRO) which works on behalf of pharmaceutical companies. CRAs are responsible for data collection and documentation as well as are often responsible for managing trial-related supplies and other research-related support tasks. The role of CRA is to ensure that clinical research / trials are conducted in accordance with Standard Operating Procedures (SOP) and International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
The CRA has the responsibility to verify that the rights and well being of human subjects are protected and that the reported trial data are accurate, complete and verifiable from the source documents and/ or patient charts. The CRA also has to ensure that the trial is in compliance with the most recently approved protocol.
Clinical trials may be carried out at various phases, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects. The CRA will be involved in all stages of the clinical trial, including identifying an investigation site and setting up, initiating, monitoring and closing the trial upon completion or termination.
✔️Evaluate clinical trial resourcing requirements for qualification, training, monitoring and support of sites during the conduct of the trials. The resourcing plan must balance the cost of travel within geographies with expertise within available resources.
✔️Develop a monitoring plan for each clinical trial.
✔️Administration and full investigator site responsibility for clinical studies according to Standard Operating Procedures (SOPs), ICH-GCP and local regulations
✔️Ensures clinical trials are monitored such that subjects’ rights, safety and well being are protected and that the clinical trial data are reliable.
✔️Train monitors (CRAs) and other clinical trial support staff (CTAs). Ensure the monitors are adequately trained on the therapeutic area and study and are prepared to train the site staff during the Site Initiation Visit (SIV) and at other times to trial-specific industry standards.
✔️Liaise with doctors/consultants or investigators conducting the trial as required to insure that monitors are meeting expectations.
✔️Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study.
✔️Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
✔️Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
✔️Gains an in-depth understanding of the study protocol and related procedures.
✔️Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
✔️Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
✔️Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
✔️Ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability
✔️Develops and maintains strong working relationship with Investigators and study staff
✔️Understands and updates Clinical Trial Management System (CTMS) in a timely manner
✔️Monitors and updates data in an Electronic Data Capture (EDC) system in a timely manner and in accordance with study specific guidelines
✔️Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study.
✔️Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
✔️Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects.
✔️Provide support for the processing of data queries.
✔️Review and approve monitoring visit reports.
✔️Develop and execute a plan to close trial sites on completion of the trial and perform associated close- out activities.
✔️Ensure adherence to GCP, Standard Operating Procedures (SOPs) and study protocols
✔️Ensure monitors are providing for regulatory compliance of investigational sites SOPs, FDA regulations, and ICH guidelines.
✔️Co-monitor as required to provide coaching and manage performance of CRAs.
✔️Generate protocol Informed Consent template.
✔️Review site Informed Consent forms and site related materials as needed.
✔️May prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, Pharmacovigilance Plan, and Informed Consents.
✔️Assist with protocol development and study report completion.
✔️Plan and participate in investigator meetings.
✔️Performs data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion
✔️Identifies and processes Serious Adverse Events (SAEs) according to the procedures defined by the study team
✔️Demonstrates a broad understanding of the SAE reporting process to regulatory authorities
✔️Liaises with data management to resolve data discrepancies and ensure all data management study goals are met
✔️Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP
✔️Prepares accurate and timely visit reports from all types of visits
✔️May be involved in preparation of status reports for clients
✔️Interacts with internal work groups to evaluate needs, resources and timelines
✔️Initiates payment requests for Investigators
✔️Ensures that disposal of the discarded testing product(s) at the trial sites satisfies the relevant regulatory criteria and is compliant with the sponsor.
✔️Verifying that site has taken as written informed consent or not before enrolling any subject.
✔️Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
✔️Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
✔️Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
✔️Hands on knowledge of Good Documentation Practices
✔️Proven Skills in Site Management including management of site performance and patient recruitment
✔️Demonstrated high level of monitoring skill with independent professional judgment.
✔️Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
✔️Ability to understand and analyse data/metrics and act appropriately
✔️Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
✔️Able to work highly independently across multiple protocols, sites and therapy areas.
✔️High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
✔️Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
✔️Works with high quality and compliance mind-set