• Liaises with project team members regarding study site issues
• Follows up with sites for trial invoices and ensures Clinical Trial Management System (CTMS) is accurately updated to allow the timely processing of Investigator Payments
• Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives
• Solves routine problems of limited scope and complexity following established policies and procedures
• Seeks assistance for more complex issues
• Keeping CTA onboarding and training manual updated. 
• Act like a buddy for the first 90 days of a new employee to help support the overall research team. 
• Take on important USO initiatives to support the growth of the clinical trial associate team.
• Acts as backup to clinical trial associate II with site selection surveys 
• Continuing education on the process so they step in and support.

Skills: Project Liaison, Invoice Management, Mentoring & Coaching, Problem Solving, Training & Onboarding, Initiative Leadership, Site Selection Support, Continuous Learning

• Organize and participate in project/study team and functional group meetings
• Set-up of Trial Master Files, Investigator Trial Files and Pharmacy Files
• Ensure the latest version of laboratory documentation are distributed and completed by the investigational sites
• Prepare and collect study documentation
• Preparation of study related controlled forms
• Order and distribute essential documents such as protocols, amendments, etc
• Maintain study documents
• Maintain TMF’s and highlight any missing and out of date documentation and assist in their acquisition as required
• Accompany and assist CRA on-site visits
• Compile, review and distribute completed Research Ethics Committee submissions
• Support induction of new team members
• Report to the Senior Project Manager

Skills: Meeting Organization, File Setup, Document Distribution, Study Documentation, Form Preparation, Document Ordering, On-site Assistance, Team Support

• Assesses operational feasibility and recommends study execution plans
• Manages study timelines and metrics
• Participates in selection and management/oversight of external vendors and develops vendor specifications
• Reviews vendor deliverables, budgets, and metrics
• Provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
• Prepares and presents project debriefings
• Plans, executes, and attends/manages study-specific meetings (e.g., Study Team Meetings, internal project team meetings, etc.)
• Participates in site monitoring visits as appropriate.
• Uses operational and therapeutic expertise to optimize trial design and execution
• Works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met

Skills: Feasibility Assessment, Timeline Management, Vendor Oversight, Budget Review, Staff Training, Project Debriefing, Meeting Management, Trial Design

• Prepares study-related documentation, supports the creation of the ICF template, CRFs, etc.
• Interface with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).
• Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
• Assists in development and management of study budget and maintains it within financial goals, reviews and approves clinical invoices.
• Reviews the electronic trial master file (eTMF) and works with CRO and functional area representatives to ensure an inspection ready eTMF.
• Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs
• Participates in the planning of quality assurance activities and coordinates resolution of audit findings
• Ensures audit-ready condition of clinical trial documentation including central clinical files
• Reviews monitoring reports to ensure quality and resolution of site-related issues
• Coordinates and assists in the planning of regulatory or ethics committee activities

Skills: Documentation Preparation, Cross-functional Interface, Document Review, Budget Management, eTMF Review, Compliance Assurance, Quality Assurance, Regulatory Coordination

• Support Clinical Affairs Management and CRAs in all activities during pre-study start-up, site initiation, site management, and study close-out
• Works closely with the clinical team and approved vendors in compliance with company internal procedures
• Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
• Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated in the study
• Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements
• Assist in the development, review, and formatting of study-specific documents, including plans, CRFs, patient documents, reference documents, and study tools
• Ensure timely completion of study tasks, update trial trackers and study metrics on an ongoing basis
• Acts as Functional TMF Document Specialist for Clinical Affairs, to include submission of documents to and maintenance of the TMF
• Reviews TMF documents as part of the Quality Review Process
• Co-monitoring as needed to assist in review the investigative site file (ISF), perform device accountability and other tasks as deemed necessary

Skills: Clinical Support, Team Coordination, Supply Tracking, Protocol Adherence, Regulatory Support, Document Development, Task Management, TMF Maintenance

• Experience in the pharmaceutical/clinical research environment 
• Able to prioritize and handle multiple tasks simultaneously
• Exceptional written and verbal communication skills
• Ability to work well under pressure and drive projects that affect critical timelines
• Knowledge of GCP, ICH and FDA regulatory requirements is required
• Able to work to high standards in a matrix environment and interact well with all level of the company
• Able to handle multiple complex priority tasks while maintaining quality and flexibility to meet deadlines.
• Work experience in life sciences or medically related field
• Biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Clinical trial process experience
• Work involving data entry into systems/databases and/or business support role

Qualifications: BA in Psychology with 2 years of Experience

• Industry experience supporting clinical studies at a CRO or pharmaceutical company
• Experience working directly for a sponsor
• Proficient in Microsoft Office.
• Professional, proactive demeanor.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Proven ability to work with a high level of integrity and raise issues when important or potential safety issues pose a risk
• Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to effectively manage clinical operational functions
• Enjoys working in a fast-paced, small-company environment
• Relevant experience with a strong background in clinical operations, program/study management, and/or clinical monitoring.
• Experience working on all Phases of studies and global/international studies

Qualifications: BA in Public Health with 3 years of Experience

• Working in data handling at a CRO, biopharma, or large medical practice/hospital
• Working in medical information processing roles
• General knowledge of GCP principles
• Experience working on cross-functional IT teams responsible for clinical information systems implementation 
• Previous experience as a CTA at a pharma company or CRO
• Good knowledge of country regulations, ICH GCP-guideline.
• Strong administrative skills
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
• Proactive, and precise in delivery of quality work even when under time pressure.
• Ability to manage the multiple priorities simultaneously
• Excellent interpersonal, oral, written communication skills
• Good level of English (written &verbal communication skills)
• Advanced level of Microsoft Office (PowerPoint, Excel, Word & Outlook)

Qualifications: BA in Health Sciences with 2 years of Experience

• Administrative experience in a corporate environment or preferably, Clinical Project Administrator experience.
• Basic knowledge of ICH-GCP and relevant regulations.
• Excellent oral and written communication skills.
• Highly methodical and organized, including time-management skills and changing priorities
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Ability to set priorities and handle multiple tasks simultaneously.
• Able to take initiative and work independently, sense of urgency in completing assigned tasks
• Accurate with a strong focus on attention to detail.

Qualifications: BS in Biology with 4 years of Experience

• Clinical research experience required, including working knowledge of ICH GCP guidelines.
• Understanding of the drug development process, and specifically, each step within the clinical trial process.
• Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
• Effective delivery of objectives in a complex matrix environment
• Ability to deal with rapid change
• Effective verbal & written communication skills in a cross functional environment
• Attention to detail
• Strong project management skills
• Proactively owns and drives assigned tasks to completion

Qualifications: BS in Biochemistry with 5 years of Experience