Clinical Trial Associate
Summary of Job Responsibilities:
The Clinical Trial Associate (CTA) will provide administrative and technical support to the Director of Clinical Monitoring, Lead CRA, Regional CRAs and Investigator Sites. The CTA administers, maintains and coordinates the logistical aspects of clinical trials according to Good Clinical Practice and relevant SOP's and acts as a pivotal point of contact for the clinical monitoring department.
Responsibilities to include:
- The Clinical Trial Associate will provide clinical administrative support and Trial Master File maintenance for clinical development functions.
- Assist with preparing and editing, tracking, and routing clinical development documents if requested, for example clinical protocols, informed consents, trial related materials.
- Assist with production of regulatory submissions and tracking of the regulatory documents to confirm sites have received full approval prior to scheduling the Site Initiation Visit.
- Assists with development and production of study materials, essential documents, presentations, reports, submissions, articles, and other materials.
- Prepare clinical study binders, track and file routine clinical study documents, either generated internally by Veristat or received from clients and or investigator sites, including meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate.
- Prepare and track courier packages.
- Assist Lead Clinical Research Associate (LCRA) in review of vendor and investigator site invoices for accuracy against budget.
- Liaise with LCRA and/or Dir. of Clinical Monitoring to ensure payments are made on time and tracked.
- Assists with travel when necessary.
- Assists in preparation for sponsor and / or regulatory audits.
- Performs other duties as required to interface with clients, study vendors and investigative sites to ensure successful trial conduct.
- Provide appropriate administrative support, version control, and document tracking for SOPs, other documents maintained under Clinical Monitoring Department.
- Maintain study specific training documentation for internal staff, regional CRAs and Investigator Site staff.
- Provide agenda, minutes and action points for meetings.
- Work with the LCRA and Regional CRAs to update the Patient Tracking Database – which includes details of patient recruitment into clinical trials, each individual’s progress through the trial, payments due to investigators, total paid to site, adverse events and other relevant patient related information.
- Maintain a database that records details of clinical trial shipments, and in collaboration with the assigned Regional CRA ensure that there are adequate supplies of clinical trial material to meet project needs.
- Plan, order and distribute non-drug clinical trial supplies e.g. clinical report forms, diary cards, trial manuals, lab supplies.
- Assist the LCRA and Regional CRAs during the preparation for the Investigator Meeting and/or Site Initiation Visit.
- Provide administrative support using Microsoft Word, Excel, Project, PowerPoint, Adobe Acrobat, and other software and systems.
- Obtain and disseminate schedules and calendars; prepare and distribute agenda for project team meetings and client meetings; prepare and distribute minutes of project team meetings and client meetings.
- Provide Dir. of Clinical Monitoring, LCRA/Regional CRAs project status updates; maintain project tracking tools; compile data for project status reports, compile study-related materials.
- Prioritize and resolve time management obstacles.
- Propose new processes to enhance the Clinical Trial Associate’s role.
Trial Master File Maintenance and Clinical Document Control:
- Archive and organize clinical trial master file documents, including clinical study site documents, email correspondence, training materials, and other study documents.
- Generate filing indexes and maintains current lists of correspondence.
- Print, prepare, file, archive, and track paper and electronic documents according to the master file structure. Increasing familiarity with documents is expected with increasing ability to take on more independent identification and appropriate handing of master file documents.
- Clinical development documents include study conduct documents (e.g. protocols, patient consents, CRFs, site qualification and IP (study drug) release documents, conduct plans, study status documents, regulatory and ethics submissions, etc.), financial information, clinical copies of clinical site and vendor contracts, correspondence, study status documents, and other study related documents.
Education, Training, Experience:
- Minimum of 2 years experience in Clinical Operations or similar department.
- Bachelor’s degree in a relevant field is preferred but not required.
- Must be a self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced office environment.
- Must be expert at using Microsoft Word, Excel, Project and Power Point. Ability to multi-task, excellent communication skills and attention to detail are all key requirements for this role.