Clinical Trial Assistant/Senior (Contract)

Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

Note to Recruiters and Agencies

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team.  Unsolicited resumes sent to Adverum will be considered Adverum's property.   Adverum’s Talent Acquisition team must expressly engage agencies for any requisition.  Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

The Clinical Trial Assistant/Senior will be responsible for supporting the conduct of clinical trials, handling administrative aspects of clinical trial execution, and tracking the progress of clinical trials. The position coordinates and tracks all study documentation, including regulatory documents, study drug documents, and clinical trial payments.

• Provide support in project-specific tasks and the overall management of clinical trials to the Clinical Operations Department.
• Assist in the coordination, organization of study management team meetings, sponsor and site, vendor teleconferences, including writing and distributing meeting minutes and agendas.
• Assist with the planning and logistics of formal meetings, including investigator meetings.
• Help to develop and write SOPs for the Clinical Operations Department
• Assist in the maintenance of central files including maintaining version and quality control of study documents submitted, assist in the file review of site clinical regulatory documentation to confirm completeness/track dates and reconciliation for audits, and preparing study files for archival.
• Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management.
• Order and maintain ancillary clinical study supplies required for conduct of clinical trials, including copying, printing study documents, reference binders, and arrange shipping, tracking, accordingly.
• Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality Agreements.
• Assist with processing invoices from vendors. Initiate requests for investigator, site, and vendor payments.
• Enters and maintains study information in Clinical Trial Management System.
• May be assigned co-monitoring responsibilities; primarily local and occasional travel may be required.
• Coordinates the review and setup of legal contracts, leases, purchase orders and other agreements for company communicating attorney feedback to internal stakeholders, as needed.
• Maintains Contracts database along with physical customer contract files and subcontractor agreements.
• Monitors contract status and communicates to internal stakeholders about contract renewals, execution of rate increases, discounts related to revenue milestones and other contractual obligations.
• Coordinates the review of RFP/Bid contract documents by company attorney and internal stakeholders to identify possible issues related to language and/or commercial terms.
• Manages approval, execution and distribution of contracts, amendments and/or extensions of contracts.
• Acts as liaison between the company, subcontractors and any/all interested parties to contractual agreements with Adverum
• Contract Management. Assistance the contracts manager as follows:
• Assistance with the processing of contracts and other documents for timely approval and signature in accordance with company policies and procedures, including proactively collaborating with stakeholders across the Company, tracking the progress of approvals and signatures, and following up where appropriate. Assist in site payment reconciliation activities ( pass through) , as needed.
• Additional Responsibilities for a Sr CTA
• The Sr CTA may assist with vendor oversight and management, help identify issues in a timely manner and escalate to management as appropriate.
• Conducts critical review and reconciliation of essential documents in TMF and independently manages TMF filing and management tasks.
• Ensure timely completion of study tasks and update trial trackers on an on-going basis.
• Audit of TMF
• Other duties as assigned.

• Bachelor’s degree (preferably in a health care or scientific discipline).
• Experience within clinical research or related experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.
• Strong attention to detail and excellent organization skills.
• Strong interpersonal skills and communication skills (both written and oral) able to work effectively in a team/matrix environment.
• Excellent verbal, written communication, and presentation skills are required.
• Experience using Office 365 (Word, Excel, Power Point) applications and SharePoint
• Experience with IXRS and EDC systems a plus.
• Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Experience in gene therapy and/or rare disease indications preferred.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.