At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Clinical Trial Associate II (CTA II) to join our A-team (hybrid). As a Clinical Trial Associate II at Allucent, you are responsible for primary administrative support to Allucent clinical study teams at Country/Site level, to support Clinical Trial Operations and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member at Country/Site Level.
In this role your key tasks will include:
- Performs quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing.
- After quality check acts as Document Submitter and submits country and site level documents to eTMF Document Inbox. Resolves rejections.
- Assists with resolution of periodic QC findings for country and site eTMF.
- If applicable, maintains study wet-ink documents temporarily in the local office and prepares shipment to the client at the end of the study.
- Communicates with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status.
- Updates Expected Documents List (EDL) in eTMF for the country and site level.
- Maintains Public Folders in accordance with Study Correspondence Management Plan
- Prepares and distributes Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs).
- Prepares and maintains QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits.
- Assists CRA with reconciliation of ISF/PSF vs. TMF and cooperates with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF.
- Assist CRAs /Clinical Trial Lead with query resolution and aged action item metrics follow up internally.
- Performs translations, back-translations or verification of translations of study documentation when needed.
- Accurately updates and maintains site level CTMS, as needed.
- If needed, assists the project team with CTMS reports at requested intervals to follow-up on pending entries
- Prepares and maintains country and sites related study trackers, as needed.
- In cases when CTA II is demonstrating high level of written and spoken English, he/she may be assigned to attend project specific teleconferences, prepare, and deliver TC minutes as requested.
- If needed, attends non-study related and executive teleconferences and prepares and distributes minutes for meeting attendees within agreed timelines
- Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information
- As needed, communicates with sites regarding trial start-up, conduct, and close-out administrative activities.
- May participate in feasibility and/or site identification activities.
- Provides training and mentoring to new CTAs on Allucent procedures and clinical trial administration, as required.
- Obtains quotes from local vendors (printing companies, translators, couriers) and provides information to the Project Specialist (PS) for obtaining approval from PM/CTL prior to placing orders
- If needed, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located
- Performs any other ad hoc administrative tasks not listed above to support team members with clinical trial execution, as required at Country/Site level.
- Provides administrative tasks to support Office Managers and Country Managers, as required.
- Other responsibilities as needed.
Requirements
To be successful you will possess:
- High School Diploma/Certificate or equivalent combination of education, training and experience; bachelor’s degree or equivalence (BS/BA) preferred.
- Experience of at least 2 years as CTA I or within a similar role or at least 3 years as a clinical research coordinator.
- Good Documentation Practices Knowledge
- Good Clinical Practices Knowledge
- Fluency in English (spoken and written).
- Strong verbal and written communication skills.
- Computer literacy, proficiency in Microsoft Office.
- Excellent interpersonal and organizational skills.
- Ability to work independently and to effectively prioritize tasks with some guidance and oversight.
- Ability to manage several projects.
- Ability to establish and maintain effective working relationships with co-workers and managers.
- Knowledge of medical terminology and clinical monitoring process
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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Last updated on Jul 10, 2024