We have a CTA career opportunity to work at a top 20 pharma.
Clinical Trial Assistance services provides support for the Local Trial Manager (LTM)/Trial Manager (TM)
and/or Site Manager (SM). Services/deliverables include the management of all documents and logistical and administrative tasks related to trial feasibility, start‐up, execution and close out of clinical trials.
Ensures trial related activities are compliant with GCO SOPs, policies, code of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC) and local regulatory requirements. Further services/deliverables will include technical regulatory document review, including Informed Consent Forms. Partners with the Local Trial Manager (LTM) and Site Manager (SM) to ensure overall site management while performing trial related activities for assigned protocols.
Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
Complies with relevant training requirements.
Provides the following deliverables: tracks progress of the clinical trial, manages study data, budget, investigational products, mailings, correspondence, and other relevant tasks in support of the LTM/TM and SM.
Negotiates site requested changes to the confidential disclosure agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts as applicable; and other relevant tasks in support of study feasibility and site assessments.
Maintains trial, country and site level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution.
Ensures current versions of the required trial documents, trial‐related materials and supplies
are provided to the investigational site(s) within required timeframes.
Collects/prepares documents required for study, such as start‐up/submission to the IEC/IRB and
HA, in support of the LTM/TM/SM where applicable.
Collects and tracks financial disclosure information at appropriate timepoints in accordance with procedural documents.
Prepares study files for investigational sites and co‐ordinates the development of associated documents and review them for completeness and accuracy.
Collects and files all documents throughout the trial and post‐trial. Uses appropriate systems to ensure file completeness at designated study milestones. Coordinates archiving of paper study relevant documents/files.
Provides updates to study specific internal data repositories to ensure availability of trial documents to the study team.
If requested, manage study budget including Affiliate spend, vendor management (including reconciliation of invoices and final budget), liaising with Accounts Payable as necessary.
If requested, organizes training for SM(s) and/or SIV/small investigator meetings.
Provide process improvement suggestions if applicable.
Ensures audit and inspection readiness, in support of LTM/TM/SM.
If applicable, region specific deliverables will be specified.
o Autonomy in execution of clinical trial assistance services.
o Depth of knowledge with clinical trial assistance services.
o Provide coaching/mentoring to less experienced CTAs, if applicable.
Metrics/KPIs governing these services are outlined in the QOP document.
Interfaces – Primary/Other:
Primary interfaces: Provider Functional Manager, company Point of Contact, Site Manager, Local Trial Manager, Clinical Trial Assistants and Central Study Team for assigned clinical trials.
Other Interfaces: Quality & Compliance Manager/Specialist, Contracts & Grants, CTAs, TA representatives, Finance, US Head, Business Operations & Quality Leader and external interfaces with Investigational site staff, vendors, Health Authority, Ethics Committee and others as required.
Education and Experience Guidelines:
BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).
Ideally 1-2 years of relevant clinical trial experience with associated skill sets.
o For Advanced services: 2+ years of experience
Proficient in English language.
Strong knowledge of MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
Strong interpersonal and negotiating skills.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
Perform activities in a timely and accurate manner
What is offered
Permanent contract of employment with DOCS seconded to the client;
Office-based in the Bucks area with the possibility of 1 day from home working flexibility
Competitive salary depending on level of skills and experience;
Company benefits: 23 days annual leave, pension, health care, etc.