Job Overview :
The In House CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.
The degree of responsibility given to the In House CRA shall reflect their experience, and level of contribution which they can make to the project.
The work will involve Clinical Trial Operations activities which will be conducted for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed.
The In House CRA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members.
Activities will be conducted in compliance with Company or Sponsor SOP’s and regulatory standards and guidelines applicable.
Essential Job Duties :
1) To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
2) To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
3) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
4) Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
5) Assist with the coordination of study visits and shipment of drug and laboratory samples.
6) To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
7) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
8) To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections.
To enter weekly details in CTMS or as per study requirement.
9) To liaise with the CTA to assist the Project Team in the production of Status Reports.
10) Assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region
11) General On-Site Monitoring Responsibilities : Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.
g. review of Case Report Forms and Study File Notebook, drug accountability).
12) Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, but does not perform remote monitoring that requires SDV.
Education / Qualifications :
University / college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.
g., nursing certification, medical or laboratory technology)
In lieu of the above requirement, ·candidates with 2-3 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
Experience : Required :
Basic understanding of biology and biological processes
Good organizational and time management skills
Good communication skills, oral and written
Exhibit general computer literacy
Works efficiently and effectively in a matrix environment
At least one year of experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data