Job-Openings

CRA-II

Clinical Research
Full Time - 30
2 - 5 Years

Essential Function:

 

  • The responsibility of a CRA II is to perform all clinical monitoring/ site management activities for assigned projects in accordance with AXIS SOPs
  • A CRA is responsible for achieving and maintaining high site performance, managing clinical monitoring activities which include the ownership of investigator sites, the selection of investigator/sites, collating regulatory documentation, initiating and monitoring of sites, performing site documentation verification, data collection and drug accountability in accordance with applicable guidelines and regulations.

 

Relationships:

Reports to:                                          Clinical Lead (CL), Project Manager (PM)

Directly supervises:                              None

Provides work direction to:                   None

Works closely with:                              Project Managers, Clinical Logistics, Data Manager, Quality Assurance, Business Operations, Finance

External relationships:                         Subcontractors

Responsibilities:

 

  • Site Feasibility: Contacts potential investigators to discusses the study details providing critical information needed to obtain the desired feedback to the assess the feasibility of the proposed study
  • Site Management Activities: 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
  • Initiate, monitor and close out investigational sites
  • Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner
  • Assist with the audit of a site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines.
  • Ensure the timely and accurate investigator payments
  • Build and maintain good and effective relationships with sites
  • Clinical Monitoring Activities:
    • Assist with the preparation and of presentation materials at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related proceduresEnsure that the site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines
    • Ensure that the site personnel are adhering to the protocol and address any issues concerning protocol non-compliance with the principal investigator
    • Provide ongoing training to the site personnel with regards to applicable guidelines and AXIS SOPs to ensure the quality and integrity of the data
    • Ensure the effective and timely co-ordination of the supply (and subsequent disposal) of clinical materials to the site to ensure that the site can start to actively recruit patients as soon as ethical approval at the site has been granted
    • Collaborate with other departments (e.g. Medical/ Pharmacovigilance, Regulatory) to ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods
    • Perform site visits to ensure that the site personnel conduct the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues should be escalated to the CL, Team Leader, Project Manager as appropriate
    • Prepare and submit visit reports in a timely manner (Per AXIS SOPs or contract as appropriate)
    • Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete, meet quality requirements and can be used as a source of reference
    • Perform ongoing on site data management/collection to ensure that issues relating to the quality of the data are communicated to the site personnel early and maintain close contact with Data Management.
    • Maintain project tracking system (CTMS or client equivalent, Patient Recruitment Plan, etc.) on an ongoing basis to ensure that progress regarding the sites can be tracked. Provide status updates to the Project Manager, CL and client as required
    • Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

 Skills

  • Excellent interpersonal, site management and relationship building, verbal and written communication skills including presentation skills
  • Team player with outstanding negotiation and organizational skills
  • Client focused approach to work
  • A flexible attitude with respect to work assignments, new learning and travel (overnight, weekend and occasional international travel may be required)
  • 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)
  • Able to take initiative and work independently (with little help)
  • Sense of urgency in completing assigned tasks

 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

 Minimum Relevant Work Experience:

  •  1+ year of on-site clinical trial monitoring experience with a pharmaceutical, CRO, or device company or similar experience or career progression from Clinical Research Assistant position

 Physical Requirements:

  • Ability to travel an average of 50%