ClinChoice
biotech
SeniorClinicalResearchAssociate
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Clinical Research Associate at ClinChoice. Skills: Clinical trial monitoring, Data management, Regulatory compliance. Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned. Conduct site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites”
What You'll Achieve.
Ensure good start-up of the investigation sites; Guarantee reliable clinical data; Guarantee timely and appropriate handling of safety issues; Guarantee smooth completion of the project
Industry & Context.
Resolution of data queries; Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned
Willingness to travel
What They're Looking For.
Must Have
Proven experience as a CRA, performing on-site monitoring activities, Knowledge of clinical trial operations, Knowledge of GCP/ICH Guidelines, Knowledge of other applicable regulatory requirements, Fluent in English, Fluent in local language(s), Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)
Nice to Have
Previous experience in Dermatology studies
What You'll Do.
Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned, Conduct site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites, Train site staff in all study procedures, Conduct periodic monitoring visits, including completion of monitoring visit report, Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF), Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data, Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.
) and their follow-up, guaranteeing timely and appropriate handling of safety issues, Conduct and report study termination and related activities (e.
archiving) guaranteeing smooth completion of the project, Act as the main contact person for the site in order to ensure close follow up, Provide general support to the Clinical Research Division on quality control of clinical data, Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner, Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial, May assist with contract negotiation with sites on study budget after appropriate training, Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites, May support the submission process in the project including submission requirements, timelines, informed consent development, etc.
How You'll Work.
Team & Collaboration
Establish a high-trust environment with the client counter-parts; Cooperate with the site staff; Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned
Communication Scope
Fluent in English; Fluent in local language(s)
Process & Methodology
Ensure good start-up of the investigation sites, Ensure timely resolution of data queries, Guarantee timely and appropriate handling of safety issues, Guarantee smooth completion of the project, Ensure close follow up, Manage internal and client processes with the same methodology
Full Job Description
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice, is searching for a dynamic Senior Clinical Research Associate to strengthen the team of one of our clients, a dynamic and innovative biotech company that offers new perspectives in dermatology. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. Main Job Tasks and Responsibilities: Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned. Site evaluation visits, initiation visits and ensure follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites. Train site staff in all study procedures. Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF). Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data. Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues. Conduct and report study termination and related activities (e. g. archiving) guaranteeing smooth completion of the project. Act as the main contact person for the site in order to ensure close follow up. Provide general support to the Clinical Research Division on quality control of clinical data. Address appropriate team members about any issues that can jeopardise the conduct of
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