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In-house CRA I

Employer
Labcorp
Location
Maidenhead, United Kingdom
Salary
Competitive
Start date
3 Oct 2019
Closing date
2 Nov 2019

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Job Details

The In House CRA 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 In House CRA shall reflect their experience, and level of contribution which they can make to the project. The work will involve Operations activities which will be conducted for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. The In House CRA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOP's and regulatory standards and guidelines applicable.

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) 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) Assist with the coordination of study visits and shipment of drug and laboratory 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 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.
9) To liaise with the CTA to assist the Project Team in the production of Status Reports.
10) 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.
11) Assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region
12) 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).
13) 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.
14) 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. 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.

15) To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements. As needed regionally.
16) 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
17) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
18) Perform other duties as assigned by management.
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, \u00B7candidates with 2-3 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
Experience:
Required:
Basic 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
At least one year of experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data
Locations:
Maidenhead, United Kingdom

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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