Clinical Trial Associate (USA) at Allucent in Cary, North Carolina

Job Description:

Description

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 the 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 /CTLs 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.

• 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
• Local to the Cary, NC, USA area and able to come into the office 2-3 times per week.
• Good Documentation Practices Knowledge
• Good Clinical Practices Knowledge
• Strong command in English language, both written and verbal.
• At least 1 year of experience in clinical research on CRO side is preferred
• Experience using eTMF, ISF/ISP is preferred.
• Excellent communication, organizational and listening skills
• Ability to confront constructively
• Fosters learning and the advancement and development of others
• Representative, outgoing and client focused
• Effective organizational, managerial, and time management skills
• Strong analytical and problem resolution skills
• Demonstrated ability to lead by example
• Demonstrated personal integrity and ethical values
• Demonstrated ability to see the bigger context and act appropriately
• Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external stakeholders
• Ability to work in a fast-paced challenging environment of a growing company
• Proficiency with various computer applications such as Word, Excel, and PowerPoint

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.”

Equal Employment Opportunity and Affirmative Action. Allucent (US) LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Allucent (US) LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.

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