Clinical Trial Associate II

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

Acts as the primary administrative support to local Pharm-Olam clinical study teams, as required by Project Managers 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 local study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member.

Responsibilities:

Trial Master File (TMF):

• 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.
• As needed, 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.

Investigator Site Files (ISF) / Pharmacy Site Files (PSF):

• 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.

Assistance to Local Site Activation Staff:

• If needed, assists CRAs / Site Activation Staff with start-up and routine IRBs/IECs submissions and tracking.
• Provides any other administrative tasks to support CRA / Local Site Activation Staff, as required.

Translations:

• Performs translations, back-translations or verification of translations of study documentation when needed.

CTMS:

• 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.

Tracking:

• Prepares and maintains country and sites related study trackers, as needed.

• Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information.

• 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.

• Other administrative support.
• Performs any other ad hoc administrative tasks not listed above to support team members with clinical trial execution, as required.
• Provides administrative tasks to support Office Managers and Country Managers, as required.

Working Relationship:

• Typically reports to Clinical Trial Associate Manager, Clinical Research Manager, Clinical Operations Manager or designee.
• Collaborates with project teams and all Pharm-Olam staff.

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