Clinical Trial Associate II (USA)

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 (CTA) to join our A-team (hybrid*/remote). As a Clinical Trial Associate at Allucent, you will be the 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 

• 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 
• 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 

• Contribute to other areas of business as required.

Requirements

• 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.  
• Located near Cary, NC, USA and able to commute to the office at least 2 times per week.

• 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. 

• Attention to detail. 

• 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 enriching 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.”