Clinical Research Associate

Job Description

• Assist with the management and preparation of tracking documents
• Assist PM with management of study drug/supply/equipment delivery, shipment, inventory, and accountability
• Assist in the preparation of ethics and regulatory applications
• Create documents required by the project team prior to the start of the study (e.g. protocols, questionnaires, feasibility, patient tracking tools, etc.)
• Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to PM to assist in site selection
• Prepare for, plan, organize and conduct site initiation visits
• Collect and review essential documents from study sites

Study conduct:

• Assist PM in developing monitoring plan
• Assist CRA I/II in identifying areas requiring follow-up and improvement at each clinical study site, and help devise a plan for corrective action
• Work with PM and study teams to create a plan to ensure a timely and successful completion of trial
• Assist in development and review of departmental SOPs and working practices
• Prepare and conduct site monitoring visits to ensure adherence with protocol, SOPs, applicable regulations and ICH/GCP
• Perform source data verification and data consistency checks to ensure data is recorded thoroughly, accurately and according to regulatory guidelines
• Ensure appropriate tracking/reporting of Serious Adverse Events (SAEs), protocol deviations and patient status
• Assist with investigator update meetings or distribution of study updates
• Assist PM to ensure payments are made and tracked accurately and on time
• Coordinate distribution, tracking, handling and destruction of study drug and non-study drug supplies per site
• Assist with in-house management of regulatory and study documentation
• Ensure data and study site documentation for the relevant study is accurate and complete according to predetermined timelines
• Ensure electronic Case Report Forms (eCRF) are submitted in a timely manner by sites
• Monitor all safety issues and conduct continuous site evaluation; work with PM/CRAs to resolve any issues

Study completion:

• Review study reports when required
• Prepare and conduct study close-out visits
• Ensure final tracking, documentation and reconciliation of all clinical supplies is complete for the study
• Ensure correct archiving of study related documents
• Ensure final reconciliation of all SAEs

Communication:

• Coach junior clinical research staff when necessary
• Meet regularly with PM to discuss continuous performance and development
• Meet regularly with PM to discuss and resolve study-related issues and to determine and manage workload and priorities
• Participate in regular meetings with the study team
• Establish and maintain a good working relationship with the investigator, site staff and other service providers
• Liaise with investigators and site staff regularly to ensure effective initiation, monitoring and close-out of the study
• Complete monitoring visit reports accurately and within the predetermined timeframe
• Ensure study progress update report is reported to the PM on a weekly basis
• Liaise with other CRAs working on the study to discuss study-related issues and study progress in order to maintain consistency across the study
• Create and update study-related databases and spreadsheets within a pre-specified timeframe
• Liaise with data management as required

Reporting Structure: The Senior CRA reports to the respective Project Manager for the study. In the absence of the PM, the Sr. CRA will report to the Manager, Clinical Operations.Skills and Experience required:

• Extensive experience in clinical studies working at a high level of competency with experience in more than one therapeutic area
• Good working knowledge of ICH/GCP guidelines and other regulatory guidelines relevant to clinical research in India
• Understanding of medical terminology and indication relating to the projects
• Proficiency in basic Microsoft Word, PowerPoint and Excel and familiarity with use of databases in use
• Adaptability and flexibility to handle ambiguous conditions and changing priorities
• Ability to work in a range of settings including autonomously, and in small work groups.

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Keyskills :
documentation site tudyreports sitemonitoring clinicalsupplies clinicalresearch trialmanagement casereportforms datamanagement microsoftword adverseevents clinicaltrials siteinitiation