In-house CRA II
Clinical Research Associates
In-House CRA – Remote Based, US
- 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.
- To support project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL.
- To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
- 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)
- Perform CRF review, query generation and resolution against established data review guidelines, n Covance or client data management systems, as assigned by management
- Might be requested to work in a client facing environment
- General On-Site Monitoring Responsibilities: PSVs, SIVs, RMVs and COVs, and act as a co-monitor for on-site RMVs as needed.
- Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, including remote monitoring that includes SDV when sites provide remote access to their EMR.
- General Monitoring Responsibilities: perform visits either as the primary monitor or the co-monitor as required by the monitoring plan to include those indicated in the chart below.
- To liaise with local or central laboratories in order to ensure adherence to the protocol, ensuring that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.
- To provide site training as needed via phone or teleconference/web meeting.
- To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date.
- To liaise with sponsor/medical monitor regarding clinical questions and study status.
- To assist with the coordination of study visits and shipment of drug and laboratory samples.
- To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- To liaise with the CTA and CRA to distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
- 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.
- To liaise with the CTA to assist the Project Team in the production of Status Reports.
- To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
- To serve as a mentor to less experienced In-House CRA staff.
- To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
- To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
- Ensure compliance with Covance SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work.
- Perform other duties as assigned by management.
- BSc or BA degree in a biological or related life science or nursing qualification
- Relevant Clinical Research experience in pharmaceutical or CRO industries may be considered
- 1-2 years experience in clinical research
- Thorough 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
- Minimum 2-4+ years of experience as a CRA with on-site monitoring experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the role.
- An equivalent combination of education and experience to successfully perform the key responsibilities of the job