• Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals.
• Train site personnel to ensure compliance with study requirements.
• Evaluate study enrollment and work with assigned sites to meet enrollment targets.
• Assess eCRFs for trends in safety, efficiency, and adherence to protocol.
• Perform on-site monitoring activities and ensure all documentation is filed within the Trial Master File.
• accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
• Prepare, submit and file high-quality monitoring visit reports and follow-up letters for assigned sites promptly.
• Lead and attend study team meetings and share pertinent information with study team members.
• Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
• Ensure all equipment/supplies provided to investigative sites are appropriately reported.
• Maintain effective working relationships with affiliate teams and external vendors.

Skills: IRB/EC Coordination, Site Personnel Training, Enrollment Management, eCRF Assessment, On-site Monitoring, Documentation and Reporting, Audit/Inspection Readiness, Vendor and Affiliate Collaboration

• Planning and conducting clinical studies applying diabetes technology
• Be responsible for data analysis and statistics
• Contribution to the development of new control algorithms for automated delivery of insulin and other glucose-regulatory drugs within an interdisciplinary framework (clinicians and engineers).
• Write and submit grants and clinical research papers independently and prepare and give oral/poster presentations at international conferences
• Come up with original ideas and work towards proving them and ultimately getting them funded through the grant submission process
• Identify, select, and monitor the performance of investigational sites for clinical studies.
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
• Write, contribute and review clinical protocols, amendments, informed consent forms, study guides, case report forms, IMP release packages and any other clinical research-related documents.
• Track and report on the progress of the study including site activation, patient enrollment, and monitoring visits.
• Act as Sponsor representative for study sites during study visits
• Oversee proper training of staff members who are working on the study
• Responsible for TMF maintenance and contribution to all other study activities

Skills: Clinical Study Design & Execution, Data Analysis & Statistical Expertise, Development of Control Algorithms, Grant Writing & Scientific Communication, Innovative Research & Funding Acquisition, Site Selection & Performance Monitoring, Protocol & Documentation Management, Training & Compliance Oversight

• Perform all types of site visits (selection, initiation, interim and close-out)
• Work following company SOPs, GCP guidelines and country-specific regulations
• Site management activities to ensure adherence to protocol, SDV and CRF
• Develop, collect, review and edit clinical trial documentation
• Assist in protocol design as and when required
• Ensure adequacy of drug shipment and drug accountability
• Liaise and form positive working relationships with all colleagues, study site staff and sponsor representatives
• Work closely and provide support to the study Project Manager
• Organise and/or attend investigator meetings
• Review all Adverse Events/Serious Adverse Events and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
• Order and coordinate study supplies for clinical studies
• Develop and maintain tracking tools to support the management of clinical studies

Skills: Site Management and Monitoring, Regulatory Compliance, Clinical Documentation, Protocol Design Assistance, Drug Shipment and Accountability, Stakeholder Liaison, Project Support, Safety and Adverse Event Management

• Implement and manage clinical study activities for current and new IVDs and Medical Devices.
• Work with the team on all clinical study aspects including CRO selection, site selection, PI selection, protocol development, support with IRB activities, participate and monitor the studies, support with data analyses, and study close-out activities.
• Guide product development teams on GCP issues for the planning of clinical field investigations to generate the data necessary to support product claims or indications required for regulatory submissions (such as 510k and CLIA Waiver).
• Initiate and maintain contact with principal investigators, study coordinators and study participants.
• Prepare and perform evaluative studies/bench studies of current and new ARKRAY products.
• Travel to field sites to initiate, supervise, monitor and audit clinical studies.
• Provide technical support and lab training to other members of the Science department as well as to other departments, functioning in a team environment.
• Support with troubleshooting existing ARKRAY products, processes, and customer complaints.
• Serve as primary contact for Clinical Research Organizations/ vendors, Investigators and study coordinators for study-related questions.
• Support feasibility and site selection process for clinical studies.
• Manage patient recruitment strategies to increase patient randomization in the trial
• Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites.

Skills: Clinical Study Management, Good Clinical Practice (GCP) Expertise, Data Analysis and Reporting, Stakeholder Engagement, Field Study Supervision, Technical Support and Training, Troubleshooting and Problem-Solving, Patient Recruitment and Site Management

• Works with relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing)
• Aid in the design and preparation of clinical and analytical performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
• Completes all activities related to the set-up, initiation, execution and close-out of device clinical trials including, site selection, collection and timely review and analysis of data generated.
• Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
• Communicates with study investigators via phone, fax, email, onsite and/or letters regarding activities in all phases of the study.
• Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
• Leads the development, organization, implementation and completion of clinical studies according to FDA standards and Good Clinical Practice (GCP).
• Provides technical training, monitoring and coordinates daily activities of trial sites
• Assists sites on planning and implementing subject recruitment activities.
• Educates and assists sites to ensure timely subject screening and enrollment
• Conducts assessments of complications and serious adverse events, including reviewing and reconciling data and documentation related to the event.

Skills: Clinical Trial Management, Study Design and Protocol Development, Regulatory Compliance, Data Collection and Analysis, On-site Monitoring and Training, Investigator and Vendor Relations, Communication and Coordination, Adverse Event Management

• Conducts quality control to ensure compliance with the study protocol, trial material storage and accountability.
• Supports IRB submissions, addendums and renewals.
• Provides technical support and training to clinical investigators and their staff regarding device trial information, the protocol, clinical and regulatory requirements and device implant support.
• Contributes to the submission of clinical data and study reports to support regulatory submissions.
• Assists in the evaluation and analysis of clinical data.
• Remains current with regulatory requirements for in-vitro diagnostic and medical device products.
• Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure the integrity of the database.
• Provides up-to-date clinical study progress reports.
• Negotiates site-specific study budgets, and initiates and oversees contract origination, compliance approval, and execution.
• Completes the tracking of budgets for studies.
• Represents Global Clinical Affairs on multi-functional teams tasked with preparing responses to regulatory agencies.

Skills: Quality Control and Compliance, Regulatory Submissions and Documentation, Technical Support and Training, Clinical Data Analysis, Regulatory Knowledge, Database Management, Budget Coordination and Management, Cross-functional Team Representation

• Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and applicable regulatory requirements in the assigned countries and sites
• Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects
• Verify adequacy, completeness, reliability, and quality of trial data collected at study sites
• Conduct site qualification, site initiation, interim monitoring and close-out visits
• Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently
• Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.
• Prepare study protocols investigator manuals, site-specific instruction manuals and design case report forms for new and modified products.
• Assist with the management of key study parameters (i.e. start-up activities, preparation of precision study specimens, data collection and data analysis, etc.)
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
• Stay up to date on major advances in infectious disease diagnosis, cancer detection and the use of new tests and advances in clinical practice
• Work collaboratively with other team members and clinical colleagues in all recruitment centers.
• Prepare the results of the project for publication

Skills: Clinical Trial Compliance, Subject Safety and Confidentiality, Data Verification and Quality Control, Site Management and Monitoring, Independent Trial Oversight, Protocol and Documentation Preparation, Issue Identification and Problem-Solving, Knowledge of Clinical Advances

• Work on an exciting project funded by a prestigious MRC award.
• Conduct a large prospective three-year longitudinal study of glaucoma patients to dissect the molecular mechanisms leading to glaucoma surgery failure, and to identify key biomarkers for clinical risk stratification and personalized glaucoma care.
• Set up a unique Glaucoma BioResource of RNA, DNA and tissue samples from glaucoma patients, linked to detailed longitudinal phenotyping.
• Have the opportunity to carry out relevant translational laboratory projects in glaucoma, 
• Participate in pre-clinical research projects to develop advanced therapeutics and nanomedicine in glaucoma surgery.
• Undertake detailed phenotyping, including history, examination, visual fields, and OCT.
• Collect tissue samples from surgical theatre lists.
• Obtain blood samples for DNA from glaucoma patients.
• Maintain a database and organize project data of all glaucoma patients.
• Carry out relevant translational laboratory projects in glaucoma.
• Present the results of the project at national and international meetings.
• Provide training and mentoring to other CRAs

Skills: Longitudinal Study Design, Molecular Biomarker Identification, BioResource Management, Translational Research, Clinical Phenotyping, Sample Collection and Management, Presentation and Communication, Training and Mentoring

• Responsible for assigned sites at the time of study start-up activities as to provide support with IRB and/or IBC submissions, preparation and assembly of study documents and study materials.
• Perform all tasks associated with the preparation, conduct (remote and on-site), and follow-up of investigational site monitoring visits (selection, initiation, interim monitoring, and close-out) ensuring regulatory, ICH-GCP and protocol compliance
• Serve as the main point of contact for assigned sites
• Manage and oversee site-level activities, including site performance with enrollment, data entry/cleaning, protocol adherence, regulatory requirements, timely safety reporting
• Ensure action items are addressed promptly as per the Monitoring Plan
• Identify and assist with the review of protocol deviations and data listings to ensure reliable quality data are obtained
• Identify and manage or escalate trial-related issues 
• Provide trial training/re-training (i.e., protocol, system, process, etc.) to site staff
• Maintain investigational site files within the study’s Trial Master File
• Assist with the preparation and conduct of investigator meetings, project team meetings, and other study training
• Actively participate in the applicable trial, department, company and/or vendor meetings
• Review trial documents, forms, and plans

Skills: Site Management and Coordination, Regulatory Compliance, Investigational Site Monitoring, Training and Development, Issue Identification and Resolution, Document Management, Communication and Liaison, Protocol Deviation Management

• Protocol management reviews all active protocols.
• Submits protocols, amendments, notices and terminations to the Institutional Review Board (IRB) for review and approval.
• Revises protocol consent forms to comply with Federal and State and IRB guidelines.
• Responsible for reporting all adverse drug reactions to the Federal Drug Administration (FDA), National Cancer Institute (NCI), Oncology Cooperative Groups, Institutional Review Board (IRB), or sponsoring drug companies.
• Responsible for NCI and drug company audits.
• Demonstrates effective communication skills with clinical staff and patients.
• Demonstrates knowledge of medical and scientific terminology.
• Organize and collect protocol-specific data in an organized and efficient manner.
• Demonstrates careful recordkeeping and documentation of research data with attention to detail and timeliness.
• Coordinates and conducts on-site audits or affiliates.
• Responsible for data collection for study analysis.

Skills: Protocol Management, Regulatory Compliance, Effective Communication, Medical and Scientific Terminology, Data Organization, Recordkeeping and Documentation, Audit Coordination, Data Collection and Analysis

• Current GCP (Good Clinical Practice) Training.
• Clinical Trial Management System (CTMS) experience.
• Study coordinator experience.
• Managed multiple, diversified tasks concurrently and prioritized projects and tasks effectively.
• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS).
• Previous experience in clinical research, preferably on-site monitoring.
• Knowledge of GCP and local laws and regulations for clinical trials.
• Computer literacy (e.g. EDC, IMPACT, MS Office, etc.).
• Good verbal and written communication skills in English.
• Effective communication skills, oral and written.
• Experience with monitoring and site management of complex Early Phase of clinical development

Qualifications: BS in Biology with 3 years of Experience

• Have health or science-related field or equivalent industry experience
• Clinical trial monitoring experience or equivalent industry experience and completion of a monitoring training course
• Specific therapeutic area experience depending on the services need: currently targeting oncology, LD hematology and ED myeloma study experience
• Strong working knowledge of ICH GCP, company standard operating procedures, local laws, and regulations, assigned protocols and associated protocol-specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with overnight stay away from home according to business needs.
• Proficient in speaking and writing in English and the country language where services will be provided. 
• Proficiency with the Electronic Medical Record (EMR) system.
• Excellent computer skills, including proficiency in Microsoft Office Products and other software programs for database management/queries, generating reports and developing graphics.
• Work experience as part of a clinical trial research team, managing protocols, and/or handling data audits and regulator
• Good Clinical Practice (GCP) and Human Subjects Protection (HSP) Certifications.

Qualifications: BS in Clinical Research with 7 years of Experience

• Clinical Monitoring experience
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
• Knowledge of clinical research data collection processes in accordance with GCP.
• Meticulous attention to detail
• Effective organizational and time management skills; ability to manage multiple assignments and changing priorities
• Have administrative, IT skills, documentation and recording skills
• Written and oral communication skills, an excellent eye for detail
• Demonstrated ability to establish and maintain effective working relationships with coworkers, managers, and contractors
• Demonstrate professionalism with internal and external contacts

Qualifications: BS in Biochemistry with 4 years of Experience

• Experience in clinical research including clinical validation studies for medical devices, in vitro diagnostic products 
• Previous experience in creating, managing, and auditing clinical trial master files and investigator site binders
• Previous experience setting up clinical study sites for clinical validation of medical devices, in vitro diagnostic products
• Knowledge of applicable clinical research regulatory requirements (ie, GCP and ICH)
• Strong written and verbal communication skills
• Proficient with Microsoft Office software: Word, Excel, PowerPoint, and Visio
• Experience with electronic document storage systems (ie, Box or Dropbox)
• Ability and willingness to safely handle, receive and ship biological specimens
• Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time
• Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers

Qualifications: BS in Nursing with 6 years of Experience

• Clinical monitoring experience.
• Knowledge of ICH and local regulatory authority regulations
• Experience in monitoring all trial components (PSSV to COV)
• Experience in coaching/mentoring other CRAs
• Strong written and verbal communication skills in English
• Able to work within remote teams
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Health care or other scientific discipline or educational equivalent and successful completion of a CRA Trainee Program
• Have on-site monitoring experience in a CRO or pharmaceutical environment
• Good written and verbal communication skills including good command of English language
• Good organizational and problem-solving skills

Qualifications: BS in Pharmacology with 5 years of Experience

• Basic knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Effective time management skills and fluent in English
• Have previous experience as a Clinical Research Associate.
• Experience and knowledge in late-phase clinical and non-interventional research.
• Strong experience in linking monitoring requirements with an EDC setting and data management activities.
• Broad knowledge of different therapeutic areas.
• MS Office Suite (e.g., Word, Excel, PowerPoint)
• CNS experience and willingness to travel per Region
• Vendor and site management experience 
• Fundamental knowledge and good understanding of GCPs, clinical study development process and logistics

Qualifications: BS in Health Sciences with 7 years of Experience

• Previous experience leading projects and Clinical study deliverables
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements
• Proficiency in Microsoft Office, in EDC systems and eTMF
• Relevant industry experience as a clinical research associate
• Must be registered/eligible for registration with the GMC
• Ability to perform a competent clinical ophthalmological examination, including the use of a slit-lamp and Goldmann applanation tonometry
• Ability to record and interpret standard ophthalmological investigations, such as visual fields and OCT
• Good IT and computer skills and commitment to high-quality research
• Should have relevant practical experience of previous clinical or laboratory research
• Should have good writing and presentation skills in English
• Ability to perform technical and intellectually demanding experiments independently

Qualifications: BS in Biomedical Sciences with 3 years of Experience

• Certification as per DM 15/11/2011
• Proven experience in Oncology, CNS, and Rheumatology therapeutic areas
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Strong communication and leadership skills
• Ability to build both internal and external relationships and cooperate with all professional figures involved in the study
• Ability to work under the supervision, ability to meet deadlines
• Good planning, organizational and problem-solving skills
• Ability to work effectively in a team and to collaborate with other research groups
• Ability to prioritize and time manage work activities and work to deadlines
• Comprehensive knowledge of GCP/ICH guidelines.
• Good documentation skills, good command of English and Chinese.
• Monitoring experiences in several different indications and study types

Qualifications: BS in Public Health with 2 years of Experience

• Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing)
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. 
• Ability to work, understand and follow work processes within the assigned function.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
• Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action
• Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity and experience as a team leader.
• Experience as a CRA or CRA leader in oncology therapeutic area
• Intermediate to business level in English
• Worked as a CRA on-site or remotely
• Ability too travel to Cheshire daily (parking is available on site)

Qualifications: BS in Chemistry with 6 years of Experience

• Previous experience working within an academic institute
• Strong knowledge of clinical documentation
• Understanding of clinical processes and procedures
• Professional experience in clinical trials (phases II and III), preferably at a CRO or pharmaceutical company and across a variety of indications
• Independent study site monitoring experience in Austria as a Clinical Research Associate ( "Klinischer Monitor")
• A solid understanding of applicable Austrian regulatory requirements as well as international standards such as ICH/GCP
• Comfortable using relevant software solutions such as Microsoft Office (Excel, PowerPoint, Word), study databases, eTMF (Veeva Vault), etc.
• Effective time management and organizational skills and a keen attention to detail
• Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
• Business fluency in German, both spoken and written as well as a good command of Englis
• Familiarity with computer systems particularly Microsoft and electronic data capture and Clinical Trial Management systems.
• Focus on detail and quality work.

Qualifications: BS in Psychology with 5 year of Experience