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In-house Cra I

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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) 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.

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.

15) To facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.

16) To undertake other project related administrative tasks (i.e. recruitment tracking, site document preparation) as appropriate, as assigned by the project Manager and CTL.

17) Might be requested to work in a client facing environment as assigned.

18) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.

19) To perform other duties as assigned by management per the monitoring plan to include those indicated in the chart below.

**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/Certifications and Licenses

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

**Labcorp is proud to be an Equal Opportunity Employer**:
As a