Senior In-house CRA
- Experience Level
- Experienced (non-manager)
Covance by labcorp is looking to recruit Senior in house CRA
With all the uncertainty in the world, your job stability should not be a concern.
Covance by labcorp have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. But we are much more than a normal CRO:
- We are also the world´s biggest Central Lab, generating more clinical trial data than all other central laboratories combined
- Our Early Phase Solutions have proved to shave off 30 % time from lead candidate to Proof of Concept
- LabCorp/Covance were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.
Join us and see why Covance by labcorp are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
* 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, 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 including phone/remote or on-site: PSVs, SIVs, RMVs, COVs, others (e.g. motivation visits etc.)
* 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 (investigators, 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.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Thorough knowledge of ICH-GCP guidelines, clinical trial process and understanding of local regulatory requirements
- Thorough knowledge of monitoring procedures process
- Valid Driver's Licens
- Speaking: English and Swedish
- Writing/Reading: English and Swedish
- A minimum of 2+ years of independent Clinical Monitoring experience as a traveling CRA with onsite monitoring experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the role.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Ability to work with minimal supervision
- Good planning, organization and problem solving abilities
- Good communication skills, oral and written
- Good computer skills
- Works efficiently and effectively in a matrix environment