• 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 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 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
• 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 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
• 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, as applicable in region
• 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)
• 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
• General Monitoring Responsibilities: perform visits either as the primary monitor or the co-monitor as required by the monitoring plan
• For visits that require direct supervision, the following staff is qualified to supervise the In-House CRA Clinical Research Associates I and 2, Sr. Clinical Research Associates, Clinical Trial Leads, Project Managers or Project Directors
• To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally
• To undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site document preparation) as appropriate, as assigned by the Project Manager and CTL; might be requested to work in a client facing environment
• To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings
• Perform other duties as assigned by management
Experience:
Minimum Required:
- At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing). One year of clinical research is preferred.
Or
- An equivalent combination of education and experience to successfully perform key responsibilities.
- Basic understanding of biology and biological processes
- Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
- Good organizational and time management skills
- Good communication skills, oral and written
- Exhibit general computer literacy
- Works efficiently and effectively in a matrix environment
- Fluent in local official language and in English, both written and verbal.
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)
Or
- 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
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