Clinical Trial Associate/Senior Clinical Trial Associate
2 weeks ago
The Role:
The Clinical Trail Associate/Senior Clinical Trial Associate, has a hands-on responsibility for the day-to-day coordination of activities within the clinical trial team.Supports the trial team with the planning, start up, execution and close out of trial activities and deliverables.
Support and coordinate activities of clinical teams and programs (all phases) in the field of Immuno-oncology and other therapeutic areas as appropriate.Support the trial teams in the management, planning, and execution of clinical trials, including administrative aspects in the execution and management of clinical trials creating and overseeing tools for tracking of trial status, documentation, etc.
This role can sit remote in the US or UK. To allow for the best candidate to be hired in this role, we are offering flexibility in our target level and job title to ensure we can hire the most qualified applicants for our team. We value your expertise and will level your role and title commensurate with your experience.
In the Role you will:
•Conducts all tasks in accordance with applicable Company Policies, Guidelines, Quality Documents, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations
•Participates in study start-up, conduct, and closeout activities.
•Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs).
•Supports trial management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
•Assembles and/or reviews regulatory packages for trial-related submissions to IRB/IECs.
•Liaises with key members of the trial and project team, both internal and external, including study site investigators and coordinators, monitors/clinical research associates and data managers and Clinical Research Organization (CRO) staff.
•Develop and maintain positive relationships both internal and external to project, including site personnel, CROs, vendors, etc
•Participate in clinical study team meetings, and record, issue and file minutes of study-specific meetings.
•Support the CTL/CTM in collection of pertinent Regulatory documents from initial trial start-up through trial close out.
•Ensure central and site file documentation is appropriately tracked and filed, e.g. TMF.Support the CTL/CTM in ensuring that documentation complies with ICH/GCP and project specific requirements.
•Support the CTL/CTM and liaise with Legal and Finance in the development, execution and maintenance of clinical study contracts and budgets. Report relevant status updates/metrics to the study team as per study-specific requirements.
•Support the CTL/CTM in initiating and tracking IRB/EC submissions, approvals and renewals.
•Work with CMC and Logistical Supply Chain to initiate study drug shipments to and returns from approved sites as approved by CTLs.
•Ensure training (including trial specific) is completed per the required timelines and trial needs.
•Proficient in using financial tools and systems and related functions to create accurate financial documents, as well as troubleshooting as required
•Ensure all financial documentation and back-up is audit ready for inspection at all times
•Responsible for calculation, submission and management of accruals each month
Qualifications, About You:
•Bachelor’s degree preferred in a relevant discipline:scientific, healthcare, etc.or equivalent.
•0-6 years pharmaceutical or related industry experience a plus; experience not mandatory
•Strong verbal and written communication skills
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