Senior CTA

• 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 request 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 communicate 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

• 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.

• 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

Your Profile:

• Bachelor’s degree preferred. Preference 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.