• Manages Site Essential Documents review during study start-up, maintenance and close-out period
• Prepares study documents and manuals (i.e. consent forms, site instructions, study-specific material such as the Manual of Operations, Pharmacy binder, etc.)
• 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
• Ensures tracking of patient status throughout the study at investigative sites
• Review and approve trip reports, track data query reports, site visit metrics, and overall site performance
• Perform site initiation, routine monitoring and close-out visits at a limited of clinical sites, as well as monitoring with local CRAs and CRO personnel.
• Reviews data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
• Assist in the preparation of, and may present at investigator vendor meetings and workshops
• Actively involved in the organization of team and vendor meetings including preparation of agenda/minute taking and updating any risk/issue/decision logs

Skills: Clinical Document Management, TMF Management, Site Performance Monitoring, Site Visit Coordination, Data Review and Issue Resolution, Meeting Preparation and Presentation, Team and Vendor Coordination, Patient Tracking

• Actively involved in the performance of study feasibility assessments
• Adheres to study timelines, quality, and budget for assigned studies
• Provides rapid action to address both internal and site QA findings from audits
• Coordinate the activities of third-party vendors including metrics, accruals, process planning, and implementation
• Tracking and maintaining study status updates internally and externally
• Assist and support the data query process
• Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
• Provides oversite of CRO and vendor activities
• Review and verify contacted vendor activities including vendor invoice review

Skills: Study Feasibility Assessment, Project Management, Quality Assurance Compliance, Vendor Coordination, Study Status Tracking, Data Query Assistance, Collaboration and Team Participation, Vendor Oversight and Invoice Review

• Provide support for Abbott Rapid Diagnostics (ARDx) Toxicology Clinical Affairs investigational studies
• Maintain effective, professional, timely, and consistent communications with clinical sites both in person and via all available correspondence media (telephone, email, web, etc..)
• Support clinical research study start-up activities (Including the creation of study binders, study logs, work instructions, case report forms, and other study-related materials)
• Train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution
• Study monitoring (Includes assessing the familiarity of the site personnel with the protocol, procedures and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation)
• Familiarity with the utilization of paper-based and electronic data capture systems for the collection of study data
• Identify data discrepancies and write queries for clarification of data
• Assist with study problem identification and solving, and ensure timely study progression

Skills: Clinical Research Support, Effective Communication, Training and Education, Study Monitoring, Data Management, Problem Solving, Documentation Skills, Detail-Oriented

• Understand clinical research activities including tasks associated with study start-up, interim monitoring, closeout, data collection and central files
• Maintain ongoing education in the area of clinical trials and research
• Provide support for other department duties, projects, and tasks as assigned in an accurate and timely manner
• Work involving blood or other potentially infectious materials required
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
• Build productive internal/external working relationships
• Carries out duties in compliance with established business policies
• Work with study sites to obtain required regulatory documentation during all phases of the study
• Collaborate on and continuously look for opportunities to streamline and improve processes
• Assist in training or mentoring new employees on the CTS activities or other CTS study-related processes
• Adhere to all required Guardant Health Standard Operating Procedures (SOP’s)

Skills: Clinical Research Knowledge, Ongoing Education, Support and Project Management, Safety and Compliance, Professionalism, Relationship Building, Regulatory Documentation, Process Improvement and Training

• Work with the Clinical Trial Managers, and other study team members, to educate and train study sites, or study teams
• Prepare, manage and track study-specific contracts, budgets, and clinical study payments in applicable systems
• Track and prepare study or department information utilizing databases, spreadsheets, and other tools (I.e.SharePoint, SmartSheet, etc)
• Manage and distribute study-related materials to all study sites
• Enter all new study sites or ongoing information into Guardant Health eTMF, and any other applicable Clinical Trial Operations system as applicable
• Completes new trial setup or ongoing information in the Clinical Trial Management System (CTMS)
• Serves as the department ‘superuser’ of eTMF and provides eTMF training to new users and study team members
• Participates in clinical systems implementations as the document management subject matter expert (SME)
• Provides document management support to clinical teams during study startup and other periods of high-volume document flow as assigned
• Participates in TMF SOP reviews and ensures TMF QC process is managed across all trials
• Completes loading and QC of TMF documents to support the department
• Manage and track clinical and non-clinical supplies, including purchase and shipping

Skills: Clinical Trial Management, Document Management, Training and Education, Database and Spreadsheet Proficiency, eTMF System Expertise, Supply Chain Management, Compliance and Quality Control, Project Coordination

• Combination of education/experience in science or health-related field
• Clinical trial management experience within either the pharmaceutical or biotechnology industry
• Understanding of ICH/GCP, and knowledge of regulatory requirements.
• Experience using computerized information systems and standard software (Windows, Excel, PowerPoint).
• Strong time and project management skills with a focus on executing deliverables.
• Ability to prioritize multiple requests and ongoing tasks effectively.
• Possesses a sense of urgency, proactively identifies potential challenges and takes initiative to identify solutions.
• Strong organizational skills and time management skills.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills and the ability to communicate effectively with all internal and external collaborators.
• Ability to work in teams, with a focus on fostering and nurturing teamwork culture and philosophy.

Qualifications: BS in Clinical Research with 5 years of Experience

• Previous experience in clinical trial coordination and/or site management for CTA. 
• Previous experience in clinical trial coordination, site management, and or vendor management for CTS
• Understanding of study phases and general knowledge of how they apply to clinical development
• Working knowledge of ICH Good Clinical Practice guidelines
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Able to identify issues and take appropriate actions
• Highly effective verbal and written communication skills
• Must have the ability to build and maintain positive relationships with management and peers
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

Qualifications: BS in Public Health with 4 years of Experience

• Experience in the Clinical trial industry preferably in a CRA, data management, or medical writing position
• Working knowledge of ICH/GCP guidelines and FDA regulations
• Knowledge of clinical trial services (eCRFs, IXRS, Central Laboratory, etc.)
• Basic medical terminology or knowledge
• Aware of professional/clinical trial industry standards, in particular, excellent knowledge of ICH GCP
• Excellent communicator and presenter with attention to detail
• Be an analytical thinker
• Proven ability to work well under stress/pressure for delivery
• Strong team player with decision-making ability
• Ability to actively resolve issues that arise during the project

Qualifications: BS in Pharmaceutical Sciences with 3 years of Experience

• Pharmaceutical industry experience in a clinical trial support role
• Knowledge of Clinical Trial Documents and trial conduct
• Knowledge of ICH/GCP
• Excellent verbal and written skills with good attention to detail and quality 
• Strong motivation, decisiveness, flexibility in thought, and creativity to excel in/contribute to a rapidly growing company
• Ability to manage multiple projects and identify/resolve issues
• Experience in an emerging, publicly-traded company environment
• A strong communicator, as well as a Problem-Solvers. 
• An efficient time manager who can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team
• Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

Qualifications: BS in Nursing with 6 years of Experience

• Experience in clinical trials with practice in project planning and structuring
• Exposure to medical terminology and physiology
• Exposure to ICH/GCP, ethical and regulatory requirements
• Working experience in clinical research
• Must have exceptional communication skills in both verbal and written form
• Must be skilled in working independently as well as working as part of a team
• Proficient with the following software including Word, Excel, PowerPoint and Adobe Acrobat
• Must be able to prioritize multiple projects and coordinate these efforts
• Be able to maintain confidentiality of information and procedures developed
• Must be able to promote a positive customer service image and maintain positive working relationships with internal and external customers

Qualifications: BS in Biology with 7 years of Experience