About the role

Essential Function: The responsibility of a Clinical Research Assistant (CRA I) is to support the project team by documenting information concerning the progress of clinical trials such that it is always complete, up-to-date and available to team members and sponsors To help communicate actions between Sponsor, project team members and to be viewed by the CRAs as an important source of project information and assistance While assisting project team for assigned projects, Clinical Research Assistant (CRA I) learns how to monitor and develop an understanding of the drug development process, relevant regulations and AXIS SOPs Relationships: Reports to: Clinical Lead (CL) or Project Manager (PM) Directly supervises: None Provides work direction to: None Works closely with: CRAs, Project Managers, Regulatory Affairs, Clinical Logistics, Finance External relationships: Third party vendors Responsibilities:

Assists CRAs, CL, and PM with updation and maintainenance of multiple types of clinical tracking systems related to study team, site compliance, performance and study milestone achievement Assists the clinical team in the preparation, handling, distribution, filing, archiving of clinical documentation and reports according to the scope of work. Obtain any missing/incomplete data from investigators in conjunction with CRAs
Prepares the correspondence to the site to send the study details, questionnaire and related matter to obtain the feedback as required
Updates the Investigator’s database on the regular basis
Assists CRAs with preparation, handling, distribution of Clinical Trial Supplies and maintenance of tracking information
Ensure CRF pages are being processed, tracked and forwarded to Data Management on time
Performs assigned duties with direction from Project Manager, to assist team members with designated administrative tasks in support of clinical trial execution and management
Prepare and submit or support those involved in regulatory and ethics committee submissions. Ensure that documents are collected in a timely manner in order to meet regulatory and ethics committee/IRB submission dates
Assist with the preparation of presentations at investigator meetings
Assist CRAs in their routine administrative tasks (e.g. metrics, arranging meetings and travel)
Attend staff meetings and training sessions as required
Completes appropriate protocol and fundamental clinical research training including the requirements of guidelines and applicable local regulations
Performs administrative duties as directed
Attend Observational Site Visits, determined by Project Manager
Participate in project meetings (taking minutes if appropriate), replace CRAs on project team calls when necessary
Have up to date knowledge on study procedures and study related materials, Responsible for completeness, quality, and accessibility of Central Files.
Supervise receipt, tracking, and archiving of documents for Central Files
Provide Clinical Lead and the team with detailed information on study procedures and study related materials
Responsible for up to date reports of study status in CTMS or client equivalent tracking systems. Organise project meetings and take minutes
Proactively flag any project related issues

Skills  Competent in written and oral English  Team player with outstanding negotiation and organizational skills  A flexible attitude with respect to work assignments, and new learning  Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail  Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of team work  IT literate (experience with Microsoft based applications and general knowledge of PC functions) Education:  Educated to Bachelor’s or Master’s degree level (biological/ life science, pharmacy or other health related discipline preferred) Language Skills:  Competent in written and oral English Physical Requirements:  Ability to travel whenever required

Clinical Research Associate - I

About the role

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