Lapcorp is actively looking to recruit an In-House CRA to join their Swedish team. This role will sit within the Clinical Operations business unit and so you will experience working on a variety of different sponsor's trials.

In essence, the IH-CRAs at Labcorp are site facing and you will be the main point of contact for the sites on your assigned studies. As such you will need to have the ability to build effective relationships with site staff in order to resolve issues and support the on-site CRAs. Naturally, the progression from these roles will be into travelling CRAs.

Overview

The In-House Clinical Research Associate 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 IHCRA1 shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical Operations activities conducted in both the office and home based setting for designated projects. Some travel may be necessary to assist with onsite monitoring visits, attend client meetings or internal team meetings, as needed. The IHCRA will be responsible for assisting with ensuring the patient safety, quality and integrity of data generated and oversight of additional study related activities. All activities will be conducted in compliance with Company or Sponsor SOP, regulatory standards and applicable guidelines. In this position, candidates will also complete the Monitoring Excellence Academy (MEA) training program which helps to develop understanding of the clinical research industry, IHCRA role and provides a basis for the development into the Clinical Research Associate role.

Key responsibilities:

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) To 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) To assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/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 liaise with Study Start-up and assume maintenance activities after Site Activation. Maintenance responsibilities including but not limited to: revision of FDA form 1572 or equivalent, Medical license expiration, CV (if applicable), Laboratory Certificate expiration, Protocol Signature Page collection, Investigators Brochure acknowledgement of receipt, Institutional Review Board submission/Approval for Annual Renewals and PI Changes.

9) To proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.

10) 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.

11) To liaise with the CTA to assist the Project Team in the production of Status Reports.

12) 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.

13) To assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region

14) General On-Site Monitoring Responsibilities per the monitoring plan to include those indicated in the chart below:

• ON-SITE: Assist Clinical Research Associate MEA I, (CRA MEA I), In-House Clinical Research Associate II (IHCRA II), Sr. In-House Clinical Research Associate (Sr. IHCRA), Clinical Research Associate 1 (CRA1), Clinical Research Associate 2 (CRA 2), Senior Clinical Research Associate 1 (Sr. CRA 1) and Senior Clinical Research Associate 2 (Sr. CRA 2) with on-site tasks as required and according to training goals (e.g. review of Case Report Forms, Site Regulatory File and drug accountability). All activity to be conducted under direct supervision of the primary monitor.
• REMOTE: 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/SDR.

Minimum experience 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.

Plus ideally:

• 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
• 100% Fluent in Swedish & English, both written and verbal

Education

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

Other Information: This role is afull time & permanent position to beemployed directly by Labcorp. You will be 100% home based. For more information please contact Andy Smith at Labcorp on +44 (0)7775 848 250 or mail andy.smith@covance.com

Key words: In-house CRA, CTA, Clinical Trial Administrator, Sweden GCP, CRO, Pharmaceutical, Clinical Administration Senior CTA, Oncology Clinical Project Administrator CPA TMF

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