• Manage the file from the initial order to the closing table ensuring the responsibilities of others assigned to the file have been completed in a timely manner.
• Schedule closings and updates utilized SoftPro.
• Produce daily reports for orders, progress tracking, etc.
• Responsible for collecting information and handling communication with listing agents, selling agents, lenders, buyers and sellers.
• Coordinate meetings, information and timelines to contribute to the monitoring of the deadlines
• Support the maintenance of clinical trial registrations on databases such as clinicaltrials.gov
• Provide general administrative support to the clinical team
• Work closely with the internal and contract research organization teams to ensure completion of the allocated tasks
• Represent the company with a high level of integrity and professionalism
• Adhere to company’s policies and support team decisions and goals in a positive, professional manner 

Skills: File Management, Scheduling & Updates, Report Production, Communication Coordination, Meeting Coordination, Clinical Trial Support, Administrative Support, Team Collaboration

• Recruit trial participants from EMRs, partner databases, social media, and other avenues
• Lead the clinical research coordinator team and train the team members
• Lead multiple clinical studies and trials, with several hundred participants in each
• Work with Viome scientific, product assembly, lab operations, bioinformatics, and machine-learning groups
• Work with many external collaborators
• Maintain accurate tracking and reporting of study data
• Coordination in all areas of clinical research
• Coordinating the initiation and implementation of clinical trials, including patient recruitment, assessments, follow ups, dispensing study medications, and taking body measurements
• Collect and monitor clinical trial data to ensure quality control and fulfillment of good clinical practice criteria.

Skills: Participant Recruitment, Team Leadership, Clinical Study Management, Cross-Functional Collaboration, External Partnerships, Data Tracking & Reporting, Clinical Coordination, Quality Control

• Support clinical study team(s) as an expert in document management
• Collect, review and file essential clinical trial documents, identify and track issues to resolution
• Prepare, manage and archive clinical study documentation in accordance with applicable regulations
• Conduct quality checks of clinical study documentation/files
• Prepare investigational device shipments, maintain stock levels and manage tracking and reconciliation of study devices
• Assist with financial accruals, site and vendor payments, and maintenance of associated payment systems
• Create and maintain internal study-specific tools (e.g., site lists, contact information)
• Manage the generation, translation, assembly and distribution of study materials
• Serve as primary liaison with document translation vendor(s)
• Assist with the planning, management and execution of clinical meetings (including internal meetings, investigator meetings and other trial-related meetings)

Skills: Document Management, Document Review, Archiving Compliance, Quality Checks, Device Management, Financial Support, Tool Creation, Meeting Coordination

• Support clinical trial sites directly/indirectly through assigned study managers
• Generate and disseminate clinical trial correspondence including newsletters, global correspondence, etc.
• Handle confidential and proprietary information in accordance with applicable laws and regulations
• Ensure optimal communication with internal and external partners specific to administrative tasks of the team
• Proactively identify and resolve operational project issues and participate in process improvement initiatives 
• Provide general logistical support for clinical trials, such as creating agendas and taking minutes at meetings, and assisting with purchasing and/or budget activities
• Plan, coordinate, and arfrange study communications and critical meetings on and off-site with both internal and external attendees, as well as drafting meeting agendas and detailed meeting minutes
• Assures currency and accuracy of required clinical trials documents (i.e. CVs Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements, etc.)

Skills: Site Support, Correspondence Management, Confidentiality Handling, Communication Optimization, Issue Resolution, Logistical Support, Meeting Coordination, Trial Master File Management

• Undertake the day-to-day management of an assigned clinical trial currently active in the imaging portfolio.
• Responsible for all aspects of trial coordination, together with data management and monitoring
• Ensure that the allocated trial is conducted to the highest scientific and regulatory standards, on time and within budget.
• Responsible for patient recruitment, coordination of imaging scans and adherence to study protocols. 
• Write, submit, and revise IRB applications
• Support the development and implementation of study protocol(s) and other study documents (Investigator’s Brochures, Informed consent Documents, Safety and Monitoring Plans, Study Training Materials etc.) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures.
• Create and maintain entries in clinicaltrials.gov
• Regularly interact with high-level internal and external stakeholders to coordinate the accomplishment of business needs

Skills: Trial Management, Trial Coordination, Data Management, Patient Recruitment, IRB Applications, Protocol Development, Clinicaltrials.gov Entries, Stakeholder Interaction

• Support Clinical Trail Leader and Clinical Trial Manager in all trial related activities during preparation, conduct and report phase of trial, including but not limited to trial team correspondence, clinical trial documents, vendor contracting, drug supplies, logistics, budget planning
• Supervision of smooth trial conduct via oversight systems (e.g. BI's Cornerstone)
• Collaboration and interaction with involved trial level functions (e.g. Trial Statistician (STAT), Trial Data Manager (TDM)) and interface functions (e.g. global ClinOps, Clinical Trial Supplies Unit, Purchasing, Legal)
• Smooth cooperation with external functions (e.g. Clinical Research Organizations, advisors, investigators) to conduct clinical trials
• Support development of approriate trial related training modules for trial team and investigators
• Maintain flow of information and organization of training sessions
• Organization and supervision of all trial related wrap-up activities (e.g. compliation of clinical trial report)
• Preparation, finalization and archiving of documents/records related to clinical trials, in accordance with internal and external regulations and guidances, and in adherence to the clinical trial document management process
• Compilation of international documents on trial level, needed to conduct a clinical trial (e.g. investigator site file (ISF) documents, vendor documents) in close collaboration with CT Leader, Site Monitoring Lead (SML) and other involved functions
• Compilation of national documents on local level, needed to conduct a clinical trial (e.g. investigator site file (ISF) documents, vendor documents) in close collaboration with CT Manager, Clinical Research Associate (CRA) and other involved functions

Skills: Trial Support, Oversight Systems, Collaboration, External Cooperation, Training Development, Information Flow, Wrap-Up Supervision, Document Management

• Support the study and/or program team(s) in the successful execution of assigned clinical trials and programs, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs).
• Partner with the Clinical Operations Lead (COL) and Study Management Team (SMT) members and/or the Director, Clinical Operations Science (DCOS) and Clinical Development Team (CDT)
• Own the development and ongoing maintenance of key operational plans and tools to ensure that on-time completion, accuracy, and quality standards are maintained through the course of the program and/or study.
• Ensure the initial population and maintenance of internal systems and tools is accurate, complete and provides a clear understanding of why any changes occur.
• Assumes relevant tasks, based on experience and training, in support of program and/or study delivery
• Follows established procedures and SOPs, seeks ways to improve and streamline.
• Submission to Ethics Committee and maintenance of ethics Documentation
• Liaise with physicians, study team, scientists and patients to coordinate research visits and study procedures.
• Observing and reporting any incidence of side effects associated with clinical trials

Skills: Clinical Trial Management, Operational Planning, Regulatory Compliance, Stakeholder Coordination, Data Integrity, Process Optimization, Patient Interaction, Adverse Event Monitoring

• Tertiary education in medical/biological/ science/ nursing or equivalent field.
• Cert III in Pathology collection or proven experience in performing phlebotomy
• Experience in the independent coordination of clinical trials and knowledge of ICH/GCP
• Demonstrated organisational and planning skills.
• Ability to work independently and part of a multidisciplinary team.
• Excellent problem-solving skills and attention to detail.
• Experience leading clinical studies and/or trials
• Must have exceptional work ethic, organizational, and communication skills
• Extensive biological knowledge, preferably in omics technologies and microbiome
• Prior interactions with FDA on trial design and data submission
• Experience leading FDA clinical trials (including IND filing)

Qualifications: BS in Biology with 4 years of Experience

• Demonstrated clinical research experience, with in-depth knowledge of human subjects research study management, including working knowledge of good clinical practices for clinical research.
• Clinical trials coordinator experience
• Experience working with CRA's and other company members.
• Experience with Medical Device and Pharma 
• Strong knowledge of ICH/GCP guidelines or other relevant guidelines
• Good understanding of Clinical trial regulation and the Clinical trial information system
• Proficiency with computer systems
• Strong verbal and written communication skills
• Strong organizational, time management, interpersonal skills
• Ability to work both independently and in a team environment

Qualifications: BS in Clinical Research with 3 years of Experience

• Relevant clinical research experience working at an Investigator Site, Sponsor or Clinical Research Organization.
• Familiarity with clinical trial operations, ICH, GCP Guidelines and other applicable Regulatory requirements.
• Good working experience in a team environment across multi-functional areas.
• Highly organized, self-motivated, detail-oriented, proactive and accurate.
• Ability to work with urgency and thrive in a high-energy, fast-paced environment.
• Demonstrate excellent communication, verbal and written, and interpersonal skills.
• Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel, Project and Publisher.
• Experience creating Clinical Trial Communications (newsletters, etc.), detailed PowerPoint presentations.
• Experience working with eTMFs and CTMS systems.

Qualifications: BS in Biomedical Sciences with 5 years of Experience

• Experience in the coordination of studies and site responsibilities around recruitment, data collection, and protocol adherence.
• Evidence of working in the field of cancer is desirable.
• Must be motivated and well organized with the ability to work effectively to deadlines both independently and as part of a team.
• Have discipline and regard for confidentiality, safety, and security at all times.
• Proven clinical trial/project management experience gained in multi-centre, phase II and/or phase III, randomised trials including CTIMPs
• Proven experience in clinical trial monitoring including source data verification
• Working knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act and Research Governance Framework legislation and proven ability to apply these to the coordination of clinical trials
• Evidence of preparing regulatory and ethics submissions, writing/amending protocols, patient information sheets, case report forms (CRF) /electronic CRF, and other relevant trial management documentation
• Evidence of strong IT literacy (MS Office and Redcap)
• Experience of data management processes using electronic CRF

Qualifications: BS in Nursing with 7 years of Experience

• Clinical Research or relevant healthcare experience
• Good communication and organizational skills
• fluent English, both spoken and written
• Good computer skills with good working knowledge of a range of computer programs.
• Experience documenting or recording Information in a clinical research, laboratory or quality assurance environment OR providing direct patient care in a healthcare environment.
• Ability to work in a matrix organization
• High sense of accountability and urgency
• Manage multiple tasks simultaneously in a fast paced and changing environment
• Able to work with a proactive, positive attitude to solving problems / proposing solutions
• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
• Advanced level skill in Microsoft Word (for example: adding developer tab, creating a macro, formatting table style, inserting comments and/or creating a mail merge).
• End-user experience with SharePoint.

Qualifications: BS in Public Health with 6 years of Experience

• Registered Nurse AHPRA approved
• Hematology or extensive general cancer ward/treatment experience
• Ability to work proficiently in periods of high demand with minimal supervision
• Effective communication skills with cancer patients, their carer's and all stakeholders involved in research projects
• Knowledge of drug development, clinical trial management and operational procedures, including GCP guidelines
• Knowledge of medical terminology and clinical patient management
• Fluency in both Dutch and English
• Demonstrated organizational and prioritization skills
• Excellent oral and written communication skills
• Proficient knowledge of Microsoft Office applications.

Qualifications: BS in Pharmacology with 3 years of Experience

• Experience working for a medical device/biotech/ pharmaceutical company in a Medical Affairs-related function.
• Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.
• Well organized, detail oriented, and accountable.
• Strong written, oral, and interpersonal communication skills.
• Flexible, self-motivated, and works well under pressure in a dynamic environment.
• Proficiency with Microsoft Office and electronic data capture (EDC) systems.
• Some experience organizing and analyzing data.
• Prior experience supporting a clinical trial as a clinical trial coordinator or equivalent at a Sponsor company 
• Familiarity with eTMF, CTMS, and EDC systems
• Strong computer skills, attention to detail, organizational skills
• Ability to communicate effectively in a fast-paced environment

Qualifications: BS in Health Science with 4 years of Experience