LEAD LOGISTICS ADMINISTRATOR

Position Summary:

The Lead Logistics Administrator in collaboration with Clinical team leaders is responsible for training, mentoring and supervising Logistics Administrators (LAs). The Lead LA serves as the primary point of contact for administrative support to the site and clinical trial team. The Lead LA is also responsible for coordinating the day to day clinical study activities and maintaining the logistical aspects of clinical trials in compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements.

Responsibilities:

· Interview, on board, and train new LAs and other clinical personnel, as necessary

· Coordinate LA team meetings, workload, and assignments, as necessary

· Identify any issues within the team and provide continuous support to all members according to standards

· Provide training and mentoring for LAs with regard to processes for clinical trial management, SOPs, GCP guidelines, and daily activities

· Ensure compliance to all SOPs to achieve overall quality and objectives and provide appropriate feedback to employees

· Develop and maintain effective relationships with all company employees at various levels of the organization

· Participate in the conduct of annual performance evaluation for LAs. Supervise, train and mentor clinical interns, as necessary

· Oversee LA activities in preparation for setting up, conducting, and completing a Clinical Trial. This includes, but is not limited to:
Primary Trial Master File Duties

· Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned

· Set up and maintenance of electronic filing systems/setup of the Investigator Site File (ISF)

· Track Ethics/Regulatory submissions and approvals for studies

· Prepare, distribute, track, and file essential clinical trial documentation

· Coordinate archiving of study documentation

· CRA and Study Team Support

· Assist Clinical Team Leads and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timeline

· Point of Contact for CRA assistance with TMF or study-related material support

· Arrange and participate in the organization of Investigator Meetings and Study Team Meetings including taking and distributing minutes and tracking of the final document
Study Management Support

· Assist the Clinical Project Manager and Clinical Team Leads in site selection process

· Assist in initial composition of Operations Manual, Pharmacy Binder, and Investigator Site File (ISF) Binder, etc.

· Manage and maintain study documents and trial supplies, e.g. Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites

· Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial

· Create and maintain study contact lists for team/sites/3rd parties

· Review study mailbox and file emails in appropriate mailbox folders

· Assist in preparation and distribution of Study Newsletters/Study Correspondence to all participating sites on an ongoing basis

· Set up finance systems accurately, process invoices and track payments for the trial for investigator and vendor payments

· Assist with collating, tracking and shipping Case report Forms (CRFs) and data queries to Data Management

· General study filing
Other possible tasks may include:

· Assist with designing of study logs, source document template, etc.

· Arrange translation of advertisement material and patient documents

· Assist CRAs on monitoring visits

· Reorder clinical drug supplies for sites

· Other duties as assigned

Required Education and Experience:

· Bachelor’s degree (or equivalent) in scientific discipline

· 2 years of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience). Prior experience in clinical research is preferred.

· Working knowledge of ICH-GCP guidelines and FDA regulations

· Strong verbal and written communication skills

· Ability to work effectively both independently and in a team environment

· Strong organizational and planning skills

· Excellent interpersonal, professional and leadership skills

· Dynamic individual with ability to lead and motivate team members

· Excellent time management skills with the ability to prioritize responsibilities and multitask

· Strong administrative skills

· Excellent documentation and file management skills

· Self-motivated and detail oriented

Contact Kelliann Quinn kelliannq@amarexcro.com