Job Summary:

• Describe issues based on facts and timely escalate identified risks/issues to correct stakeholders for resolution. 
• Be aware of the risks of each phase, timely propose solutions and implement them
• Able to analyze independently, actively solve routine problems, and seek support 
• Conducts reference material testing in-house
• Organizes investigator meetings
• Communicate frankly, clearly and effectively during internal and external collaboration. 
• Actively share the accumulated working experience
• Communicate with external institutions such as site and HGRAC in a appropriate way, get support from parties to complete work
• Conduct Other projects or tasks assigned by line manager
• Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection

Skills on Resume:

• Risk Management (Hard Skills)
• Problem Solving (Hard Skills)
• Compliance Testing (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Event Coordination (Soft Skills)
• Knowledge Sharing (Soft Skills)
• External Negotiation (Soft Skills)
• Project Leadership (Soft Skills)

Job Summary:

• Supports all phases of clinical development and execution
• Conducts site qualification, initiation, interim monitoring, and close out visits
• Train sites on protocol, process, systems, and study management
• Ensures high quality data by being the study protocol expert and key site resource for questions
• Data monitoring both remote and onsite
• Collects and maintains site essential documents
• Maintains and tracks clinical study data and support in investigator qualification selection, analysis of potential patient recruitment, study site support through the life of the study.
• Heavy contribution to the preparation of study related documents including CRFs, ICF, clinical monitoring plan
• Understands therapeutic area for assigned clinical projects
• Other projects may be assigned related to clinical studies
• Support the SI-BONE Quality System

Skills on Resume:

• Clinical Development (Hard Skills)
• Site Monitoring (Hard Skills)
• Protocol Training (Hard Skills)
• Data Quality Assurance (Hard Skills)
• Data Monitoring (Hard Skills)
• Document Management (Hard Skills)
• Study Preparation (Hard Skills)
• Quality System Support (Hard Skills)

Job Summary:

• Perform clinical research and patient-reported outcome activities under supervision per approved protocol including data collection, data entry, data verification, data analysis, and compliance within the Combined Spine Research Program
• Conduct basic library research to assist investigator publication of journal articles and grant proposals
• Demonstrate experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to assist in providing successful presentations to those professionals
• Assists with orientation of new team members
• Anticipates and carries out independent actions necessary to provide competent and professional support to meet the needs of the faculty physicians, patients, administrators, co-workers, and others involved with clinical trials
• Acts as a resource to investigators, faculty physicians, and clinical research coordinators
• Under supervision, maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service, periodically reviews data for compliance
• Assists clinical investigator and study coordinators with study initiation, conduction, and completion

Skills on Resume:

• Clinical Data Management (Hard Skills)
• Library Research (Hard Skills)
• Healthcare Communication (Soft Skills)
• Team Member Orientation (Soft Skills)
• Proactive Support (Soft Skills)
• Clinical Resource (Soft Skills)
• Database Maintenance (Hard Skills)
• Study Coordination (Hard Skills)

Job Summary:

• Participates and/or represents the Combined Spine Research Program at research, protocol, or research meetings as assigned
• Support internal projects and initiatives and perform other duties as assigned
• Assures that data entry remains current for all studies per SOP
• Reviews and utilizes protocols as guides for study activities
• Ability to maintain a positive, cooperative and collaborative attitude with the research team
• Maintain a professional demeanor with sponsors, monitors, and auditors
• Remains current with all required training
• Works independently under limited supervision to determine and develop an approach to solutions
• Interacts professionally with study participants

Skills on Resume:

• Research Representation (Soft Skills)
• Project Support (Soft Skills)
• Data Entry Compliance (Hard Skills)
• Protocol Review (Hard Skills)
• Team Collaboration (Soft Skills)
• Professional Conduct (Soft Skills)
• Training Compliance (Hard Skills)
• Independent Problem-Solving (Hard Skills)

Job Summary:

• Maintain literature libraries for respective scientific areas for new product development.
• Assist in collaboration with a multidisciplinary team in development, creation and execution of study protocols.
• Assist in preparation and review of pre-clinical and clinical study reports.
• Gain and maintain scientific, technical and clinical expertise in molecular diagnostics for infectious diseases and oncology.
• Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US and EU regulation as well as with Cepheid’s policies and procedures.
• Assists Principal Investigators in planning and implementing clinical research studies.
• Independently conducts data collection, organization, and analysis activities
• Critically evaluates analyses and results and provides summaries and interpretations to team.
• Collaborates with other researchers internally and externally to plan studies and interpret findings.
• Supports grant identification and proposal processes and the writing and publication of reports, presentations, abstracts, and posters.
• Contributes to the team within and between departments and projects.
• Offers coaching and support to research interns and co-ops.

Skills on Resume:

• Literature Management (Hard Skills)
• Protocol Development (Hard Skills)
• Report Preparation (Hard Skills)
• Scientific Expertise (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Clinical Study Assistance (Hard Skills)
• Data Analysis (Hard Skills)
• Collaborative Research (Soft Skills)

Job Summary:

• Coordinating the preparation and maintenance of study documents, including: Start-up packets, Regulatory Binders and Site study tools
• Assisting with content creation, formatting, editing reports and other clinical documents
• Coordinating the preparation of study-specific Project, Site, and Subject files
• Interacting with Site staff to send, request, and collect regulatory documents
• Assisting with Quality Control (QC) regulatory document content for compliance and being prepared to speak for record quality and maintenance
• Performing routine and final reconciliation of Project, Site, and Subject files
• Creating, tracking, and maintaining training records for Contract Research Organization(CRO), study teams, and site personnel to maintain study records using electronic filing system (eFile)
• Assisting with Clinical Trial Management System management to create and maintain Protocol and Site records, track documents and activities, maintain study team rosters, identify documents for review / reconciliation by Site monitors, assign Site numbers, and provide support as key system users
• Performing Device Accountability reconciliation (i.e., track shipment, receipt, and return of study devices)

Skills on Resume:

• Document Coordination (Hard Skills)
• Content Editing (Hard Skills)
• File Preparation (Hard Skills)
• Regulatory Interactions (Hard Skills)
• Quality Control (Hard Skills)
• Data Reconciliation (Hard Skills)
• Training Record Management (Hard Skills)
• Device Accountability (Hard Skills)

Job Summary:

• Reviews research protocols to determine availability of resources, subjects and equipment needs.
• Educates patients and families about clinical trials, potential benefits and goals of clinical research. 
• Communicates to physicians and other staff concerning protocols that are open to enrollment
• Obtains written informed consent with appropriate HIPAA authorization from each patient prior to study enrollment.
• Conducts study as outlined by protocol. 
• Follows established guidelines in the collection of data. 
• Ensures regulatory compliance for each study by following IRB policies and procedures, study requirements, federal regulations, etc.
• Participates in sponsor audits and/or regulatory inspections of records and documents.
• Recognizes, supports and utilizes evidence-based clinical practices.

Skills on Resume:

• Protocol Review (Hard Skills)
• Patient Education (Soft Skills)
• Enrollment Communication (Soft Skills)
• Informed Consent (Hard Skills)
• Protocol Adherence (Hard Skills)
• Data Collection (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Audit Participation (Hard Skills)

Job Summary:

• Medical record and other source documentation review for data entry into the electronic database and trial management system.
• Work to resolve data queries in a timely manner.
• Log AEs and obtain PI review and sign-off and report SAEs as directed by PI.
• Contribute with regulatory staff in adverse event reports and protocol deviation reports for submission to IRB.
• Facilitate the consenting process by providing study documents to the investigator, ensuring the subject receives all copies of signed materials, and informing subjects about study requirements.
• Collect study diaries and questionnaires from subjects.
• Promptly document and track protocol deviations and work with regulatory to report any observed protocol/trial issues to the PI, Sponsor, and IRB.
• Assist in preparation of sponsor and regulatory agency audits and inspections.
• Assist in quality assurance/quality control activities to ensure accuracy and completeness of clinical trial data.
• Develop close-working relationship with study monitors to resolve queries and IMV follow-up items.

Skills on Resume:

• Data Review (Hard Skills)
• Query Resolution (Hard Skills)
• Event Logging (Hard Skills)
• Regulatory Reporting (Hard Skills)
• Consent Facilitation (Soft Skills)
• Document Collection (Hard Skills)
• Deviation Tracking (Hard Skills)
• Audit Support (Hard Skills)

Job Summary:

• Communicate with Sponsors on recruitment and other study updates.
• Participate in site initiation visits, attend research and investigator meetings.
• Assist in study specimen procurement, specimen shipping and handling according to regulatory requirements
• Contact external providers and medical facilities for data on patients previously treated at other institutions.
• Perform follow-up for study patient survival by reviewing medical records and/or calling patients.
• Perform tasks in accordance with FDA, HIPAA, ICH GCP, IRB, study protocol, and other applicable regulations.
• Ensure confidentiality, accuracy, security, and appropriate access of all data and records.
• Maintain clear communication with research team members.
• Provide coverage for other team members in their absence.

Skills on Resume:

• Sponsor Communication (Soft Skills)
• Site Visits (Soft Skills)
• Specimen Handling (Hard Skills)
• Data Collection (Hard Skills)
• Patient Follow-Up (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Security (Hard Skills)
• Team Coordination (Soft Skills)

Job Summary:

• Creates research or evaluation data collection tools, information and educational materials which may include trainings, counseling, printed materials, electronic media, reports or presentations.
• Works with clinical or community partners to ensure ease of project start-up and implementation.
• Conducts educational classes and provides counseling or guidance for study patients or community members.
• Communicates directly with internal and external partners including KPCO, industry, funding and/or community partners to exchange information necessary to the research/evaluation team efforts.
• Assists investigators and project partners with collection and analyses of intervention data, which may include applying basic statistics, qualitative analyses, and/or process and outcome evaluation methods. 
• Records research data in case report form
• Responsible for the documentation and reporting of adverse events.
• Conducts focus groups, qualitative interviews or other direct data gathering
• Reviews surveys for accuracy, edits and codes data. 
• Assists project manager in the delivery of the study intervention or evaluation activities that may include obtaining patient informed consent, providing health education or counseling, or advising community partners on evaluation of community-based initiatives. 

Skills on Resume:

• Material Development (Hard Skills)
• Project Implementation (Soft Skills)
• Educational Counseling (Soft Skills)
• Partner Communication (Soft Skills)
• Data Analysis (Hard Skills)
• Data Recording (Hard Skills)
• Adverse Event Reporting (Hard Skills)
• Focus Group Conduct (Soft Skills)

Job Summary:

• Monitors and follows-up on research subjects. 
• Documents all research subject visits, site visits, study meetings.
• Assist in designing data collection or abstraction forms. 
• Assists investigator with abstract and manuscript development. 
• Communicates with project manager or investigator and supervisor regarding study task progress.
• Adhere to federal and local regulations and KPCO Standard Operating Procedures governing research. 
• Maintain compliance when manipulating large volumes of patient data, both internal to KPCO and from external agencies. 
• Follow the IRB approved protocols on federally funded grants as well as on internally funded projects. 
• Adhere to the research protocols for maintaining HIPAA compliance when accessing, manipulating, storing, and transferring data. 
• Partner with Investigators to adhere to the research requirements outlined in the study protocol and data use agreements report all violation/deviations immediately to the Investigator and IRB.

Skills on Resume:

• Regulatory Compliance (Hard Skills)
• Data Management (Hard Skills)
• Accurate Documentation (Hard Skills)
• Protocol Adherence (Hard Skills)
• Effective Communication (Soft Skills)
• Research Design (Hard Skills)
• Manuscript Development (Hard Skills)
• Problem-Solving (Soft Skills)

Job Summary:

• Oversees, designs, plans and develops registered and non-registered clinical research studies in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations. 
• May be involved in early study development including statistical design of the trial.
• Prepares, authors, and oversees protocols, informed consent forms, study plans, timelines, and budgets.
• Assists in overseeing and interpreting results of clinical investigations in preparation for new device or consumer application / device indication.
• Oversees clinical study operations performed by other team members, including safety, monitoring, data management, and site and vendor selection.
• Maintains understanding of regulatory requirements across multiple regions.
• May represent Clinical Affairs team on certain product core teams providing Subject Matter Expert support with clinical requirements in accordance with SOPs and regulations.
• Works alongside the United States (US) clinical research team, reporting into a US manager.
• Provides technical assistance to clinical study sites by serving as the technical resource between engineering and the medical community, potentially present in the operating room during clinical procedures as well as physician office to facilitate patient testing and data collection.
• Typically present during initial implant to determine how the product interacts with a human body.

Skills on Resume:

• Clinical Study Oversight (Hard Skills)
• Statistical Design (Hard Skills)
• Protocol Authoring (Hard Skills)
• Data Interpretation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Team Leadership (Soft Skills)
• Technical Assistance (Hard Skills)
• Subject Matter Expertise (Hard Skills)

Job Summary:

• Accountable for identifying investigators, presenting protocols for a study, assisting investigators in product application, and submitting status reports on all programs.
• Assesses project issues and develops resolutions to meet productivity, quality, and objectives.
• Develops mechanisms for monitoring project progress and for intervention and problem solving
• Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.
• Provides all aspects of assistance for Clinical Research studies by identifying investigators, nominating sites, performing activation duties, providing training, encouraging enrollment, ensuring quality data acquisition and performing study closure activities.
• Accountable for gaining and maintaining knowledge of clinical sites to best understand and assess physicians’ interests and capabilities.
• Plays a critical role in educating customers, sales partners and internal Clinical Research talent on the technology that they assist.
• Develop and support individual research activities in the field by assisting physicians with research interests, drafting protocols for reviews, and supporting preparation of abstracts and/or scientific exhibits, posters and verbal presentations of accepted abstracts at key professional society meetings.

Skills on Resume:

• Investigator Recruitment (Hard Skills)
• Project Management (Hard Skills)
• Problem Resolution (Hard Skills)
• Strategic Presentations (Soft Skills)
• Study Activation (Hard Skills)
• Site Knowledge (Hard Skills)
• Educational Outreach (Soft Skills)
• Research Support (Hard Skills)

Job Summary:

• Conduct primary research and manage clinical studies needed to support product development
• Planning and definition of study protocol to execution by externalclinicians/researchers. 
• Analyze and consolidate supporting evidence for product claims. 
• Establish and manage relationships with outside agencies and organizations (such as OSHA, CDC, ADA, OSAP) to continually update knowledge base of industry trends. 
• Monitor research of other dental companies, to raise awareness and assess potential applicability to company products.  
• Establish strong network of contacts within the dental academic and research communities.  
• Collaborate and support materials for education and training of Zyris team. 
• Conducts preliminary feasibility review of submitted studies.
• Issues approval for protocols that do not require clinical services. 
• Evaluate protocol for required clinical services.
• Coordinates with the required clinicians/clinical departments.
• Creates billing plan, including Medicare Coverage Analysis documentation, and issues approvals for clinical services to be provided. 
• Coordinates revision of approval documents per the clarifications from study team.

Skills on Resume:

• Primary Research (Hard Skills)
• Study Protocol Planning (Hard Skills)
• Evidence Analysis (Hard Skills)
• Relationship Management (Soft Skills)
• Industry Monitoring (Hard Skills)
• Network Development (Soft Skills)
• Educational Support (Soft Skills)
• Protocol Evaluation (Hard Skills)

Job Summary:

• Providing a safe environment for patients.
• Reporting safety concerns, errors and near misses.
• Participating in system improvement initiatives to prevent errors.
• Providing evidence-based care as applicable to the role.
• Prepares Institutional Review Board applications for submission including new, amendments, and continuing reviews.
• Coordinates and may participate in all site visits, which may include pre-study, initiation, monitoring and closeout visits
• Maintains accurate and essential documents per study as required by FDA, IRB, sponsor and other regulatory agencies or funding agency.
• Schedules patient research visits
• Reviews and processes research patient bills using the Epic Research Module billing review system. 
• Acts as liaison between study Research Coordinator/Nurse and RABO to resolve any billing discrepancies.

Skills on Resume:

• Patient Safety (Soft Skills)
• Safety Reporting (Hard Skills)
• System Improvement (Soft Skills)
• Evidence-Based Care (Hard Skills)
• IRB Submissions (Hard Skills)
• Site Visit Coordination (Hard Skills)
• Document Management (Hard Skills)
• Billing Coordination (Hard Skills)

Job Summary:

• Participates in the design, planning, implementation and overall direction of clinical research projects, may contributes technical and clinical operation expertise 
• Be aware of the task of each phase, ensure the task completion of each phase in a planned way
• Plan and prepares studies, under supervision, including but not limited to site qualification, regulatory submission (e.g. HGRAC, EC and/or NMPA), study supply, site initiation, routine monitoring and close-out activities
• Apply reviews study protocols, reports and manuscripts. 
• Contribute technical and clinical operations expertise for these documents
• Works with Data Management and Biostatistics staffs on the design of documents and processes for the collection of study data from participating sites
• Collects and maintains legal and regulatory documentation throughout a study
• Assumes responsibility for training and coordinating certification of study site personnel
• Ensures accurate and complete study management/data collection and transfer to data management
• Ensures study conduct and execution at site compliance with regulations and study protocol.

Skills on Resume:

• Project Design (Hard Skills)
• Phase Management (Hard Skills)
• Regulatory Submission (Hard Skills)
• Protocol Review (Hard Skills)
• Technical Expertise (Hard Skills)
• Data Design Collaboration (Hard Skills)
• Documentation Management (Hard Skills)
• Site Training Coordination (Hard Skills)