Clinical research coordinator jobs in Columbus, OH

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details This role is in support of Cencora's wholesale distribution services in Europe operating through our Alliance Healthcare business. The mission of a Project Manager is to ensure the correct execution of the different tasks of the study in terms of quality and timelines. To achieve the project's goals, the Project Manager should organize teams and assign responsibilities to ensure effective collaboration, develop and oversee the execution of the project plan, and maintain open lines of communication with stakeholders, team members, and clients. Role Responsibilities: Develop project plans that align project objectives with the organization's overall strategy. This includes defining the project's roadmap, objectives, scope, deliverables, and necessary resources. Identify, evaluate, and mitigate risks associated with the project. Establish contingency plans to address potential issues that may arise during the project's lifecycle. Act as the main point of contact between internal and external stakeholders, ensuring clear and effective communication. This includes reporting project progress, resolving conflicts, and managing expectations. Ensure that the project complies with all applicable regulations and standards, including the company's internal policies and external laws affecting the project. Be the main actor and leader while setting up a project. Develop and maintain detailed project schedules, ensuring that all necessary activities are planned, and deadlines are met. Track project progress, identifying and resolving any issues or deviations from the original plan. Ensure smooth invoicing and forecasting. Ensure that the project remains within the defined scope and manage any change requests that may arise. Oversee the implementation of quality standards throughout the project lifecycle to ensure deliverables meet specified requirements. Maintain accurate records of project progress and prepare periodic reports for senior management and other stakeholders. Collaborate closely with cross-functional teams including all the Internal stakeholders to ensure seamless integration of clinical trial supplies/services into ongoing operations. Perform other duties as assigned. Experience and Education: Bachelors degree in Engineering, Health Sciences, or related fields. Minimum of three (3) to five (5) years of experience as a Project Manager, preferably in projects involving external client contact. Previous experience in logistics preferred. Previous experience in clinical trials preferred. Skills and Abilities: Ability to communicate effectively both orally and in writing. Strong organizational skills; attention to detail. Ability to meet deadlines and consistently deliver solid results. Excellent problem-solving skills; ability to manage and resolve issues effectively and efficiently. Demonstrated critical thinking and aptitude for synthesizing broad and complex sets of information into actionable recommendations. Ability to build relationships and work collaboratively with all levels of individuals across the organization and externally Strong negotiating skills. Result-driven with ideas to drive continuous improvement process. Ability to function in a high pace environment, multi-task, manage and prioritize various and differing projects, as well as work effectively toward numerous deadlines. Advanced skills in Microsoft Office Suite. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Amerisource Health Services, LLC

The Center for Clinical and Translational Research in the Abigail Wexner Research Institute at Nationwide Children's Hospital is expanding its faculty. The primary mission of this Center is to answer questions that will improve the early diagnosis, treatment, and outcomes of society's most important pediatric diseases by combining high-quality, fact-based lab discoveries and innovative patient-based research. More information is available at: Center for Clinical and Translational Research (nationwidechildrens.org) About the Faculty Position: Seeking Assistant, Associate, or Full Professor ( Tenure Track at The Ohio State University College of Medicine ) Candidates should have a research laboratory focused on thrombosis, hemostasis, and/or vascular biology Will establish an independent research program Will help revolutionize the prevention and treatment of thromboembolic disease in children Qualifications Required: MD, MD/PhD, or PhD Strong track record of publishing in high quality journals Current K-award, R01 or equivalent federal grant funding is required About the Center for Clinical and Translational Research: The Center for Clinical and Translational Research integrates basic, translational, and clinical research programs to advance discovery of innovative diagnostic and treatment tools that will address major challenges in the field of pediatrics Currently expanding to establish a pediatric thrombosis and vascular biology research emphasis group that will complement 17 Principal Investigators presently in the Center New faculty members will have strong ties to the Division of Hematology/Oncology/Blood and Marrow Transplantation and will be active members of the newly established Blood Disease Research Affinity Group Principal Investigators are also Faculty members at The Ohio State University College of Medicine Send correspondence, including curriculum vitae, a brief statement of research interests, and contact information for three references to *************************************** in Faculty Recruitment. Summary: Designs experiment and develop protocols required to conduct meaningful research in a specific area of scientific research. Trains and guides technical staff involved in specific projects and performing techniques. Plans future directions and seeks sources of funding for a research group. Records, collects, and analyzes data from research studies, and publishes results in appropriate refereed scientific journals. Presents study results to Research Institute (RI) staff as well as at national scientific conferences. Collaborates with other RI investigators in a manner that will enrich the overall institutional research effort. Prepares for seeking and obtaining external research funding. Serves as a mentor to RI post-doctoral research fellows (Research Scientists). Job Description: Essential Functions: Designs experiments and develops protocols necessary to conduct meaningful research in a specific scientific area. Does “hands-on” performance of techniques as needed to complete projects. Ensures that research projects are conducted efficiently, correctly, and in a timely manner. Trains subordinate research staff such as technicians, graduate students, post-doctoral fellows, etc. so that they can perform techniques required for conducting the studies. Records, collects, and analyzes study data to be able to reach valid conclusions. With the results in mind, plans for future research directions and studies. When study data has been analyzed statistically, prepares papers and publishes results in appropriate scientific journals. Presents results and conclusions to scientists at the weekly CRI research meetings and at national conferences. Collaborates with other RI and OSU investigators to mutually benefit research efforts. Serves as a resource in a particular area of scientific expertise. Provides mentorship to graduate students and post-doctoral fellows (Research Scientists) in preparing them to be independent researchers. Performs appropriate duties as a member of the faculty of the Ohio State University College of Medicine. Prepares scientific proposals to seek external research funding whenever possible. Prepares and monitors capital budget for the area of responsibility. Responsible for authorizing expenditures from approved grant funds. Recruits, hires, terminates and trains assigned staff. Trains staff for compliance to hospital policies, RI, NIH, NRC, AALAC requirements and OSHA standards and regulations. Also conducts training on animal care and use as appropriate. Education Requirement: Ph.D. or MD/Ph.D. or equivalent degree and having completed a post-doctoral fellowship in a pertinent area of scientific expertise. Licensure Requirement: (not specified) Certifications: (not specified) Skills: Good communication skills, and ability to prepare scientific publications, presentations and proposals. Technical skills in an appropriate area of research. Ability to teach and train junior scientists. Desire to pursue a career in biomedical research, and knowledge of the research process. Experience: (not specified) Physical Requirements: OCCASIONALLY: (none specified) FREQUENTLY: (none specified) CONTINUOUSLY: (none specified) Additional Physical Requirements performed but not listed above: Pressure in this position will vary depending on the workload. The workload will be heavy but manageable most of the time. Pressure may arise in the face of deadlines associated with grants, required documentation related to the physician's OSU faculty appointment, etc. "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. Summary: The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. Responsibilities And Duties: Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. Minimum Qualifications: Bachelor's Degree (Required) Additional Job Description: required from a four year college or university SPECIALIZED KNOWLEDGE Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) DESIRED ATTRIBUTES One year of relevant work or academic experience preferred Prior experience in a medical environment preferred Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification) One or more years of direct human subjects research Clinical knowledge in assigned therapeutic area or program MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carryout the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations. Assist with recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participate in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. After closeout visits have been conducted, prepares study documents for archiving according to timelines. Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe and report adverse events and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Work with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. Work Shift: Day Scheduled Weekly Hours : 40 Department Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

Lead Clinical Robot Associate - Columbus, OH (on-site) We envision a future powered by robots that work seamlessly with human teams. We build the artificial intelligence that enables service robots to collaborate with people and adapt to dynamic human environments. Join our mission-driven, venture-backed team as we build out our customer-facing operations arm. As part of Diligent Robotics' founding operations team, you will uphold the highest standards for safe clinical use of robots in real-world hospital environments. Through excellent communication and documentation, you will work alongside the hospital staff and our engineering team while assisting a cutting-edge fleet of robots. As part of the founding team, you will help design and implement processes as the organization scales. Clinical Robot Associates will solve unexpected situations that might arise during a shift, and work effectively as a team to ensure exceptional results to our hospital partners. This is a full-time, Supervisor role at Diligent Robotics and working 9am - 5pm, Monday-Friday. This position is located in Columbus, OH and you must be local and willing to work on site to be considered. This is not an engineering position and a background in robotics or engineering is not required. If you have ever been an outstanding customer service representative helping busy customers with their needs, you may be a great fit for the role. Your day-to-day responsibilities will include: Monitoring and safely assisting mobile service robots in a hospital environment Collecting data and troubleshooting in a variety of real-world situations, while simultaneously providing detailed and accurate feedback to our engineers Prioritizing the customer experience, ensuring their expectations are always met or exceeded Communicating with hospital staff and, occasionally, the public regarding robot operation Your supervisory responsibilities will include: Prepare and publish monthly schedules Onboarding and training new Clinical Robot Associates Approve time cards Escalating corrective action issues Find coverage with callouts A good candidate would be, at minimum: A high school graduate or possess a GED Supervisory experience: Experience leading a small team including scheduling, training, and support. Customer-service oriented: you are friendly, skilled in the art of de-escalation, and an able juggler of customer demands and company needs An excellent written and verbal communicator: you convey information to internal stakeholders in phone calls and direct messenger Organized: you can juggle and make progress on multiple tasks simultaneously Self-sufficient: you get things done, learn what you don't know, and can make quick decisions independently, as circumstances require Able to lift up to 40 pounds Able to work varying shift times including nights and weekends and understanding that your schedule may shift as customer needs change over time Willing to work during significant holidays: you understand that our customers (i.e. hospitals) don't shut down during the holidays and neither can our robots Willing to be vendor credentialed: our customers have strict standards and employment will be dependent on obtaining vendor credentials, the process of which will include various immunizations, a background check, a drug screen, among other steps The ideal candidate would be: Extraverted: you can strike up a conversation with anyone and everyone loves your presence Responsive and responsible: you commit to deadlines, err on the side of over-communication, and understand the challenges of working with some co-workers that may be remote. Results-oriented: you're happy to observe and take notes on end users interacting with the robot all day if that's what it takes Passionate about healthcare and technology coming together to help people Formerly employed in the healthcare space: you have an insider understanding of the vernacular, organizational structure, and operational processes of hospitals Passionate and clear-eyed when it comes to robots: you understand that there's a gap between technological reality and media-driven expectations and are excited about the opportunity to move the industry forward by whatever means necessary, even if it isn't glamorous We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job DescriptionCompany Overview : Dozee Health AI is the pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India's no. 1 RPM Company. We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you'll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models Role Overview: The Field Clinical Coordinator plays a key role in supporting healthcare professionals,primarily nurses, to ensure the effective utilization of clinical systems and devices. This position involves facilitating seamless device installations, guiding staff on proper usage and best practices, and providing on-site support for technical troubleshooting and operational issues Responsibilities Training & Assistance for Nurses & Care Teams Deliver hands-on training to nurses and caregivers on device operation, maintenance, and interpretation of readings Provide on-site and remote support to address common device and system issues Ensure compliance with facility protocols and company guidelines during device use Coordinate and facilitate telehealth assessments in collaboration with Nurse Practitioners (NPs) Support nursing teams in performing basic patient reviews for stable patients Maintain strong clinical understanding, communication, and bedside interaction skills On-Site Troubleshooting & Technical Support Respond promptly to service requests to resolve device malfunctions or connectivity issues Diagnose and address minor hardware or software problems, escalating complex cases to the technical support team Replace or maintain faulty devices to ensure uninterrupted clinical operations Ensure all necessary firmware updates are applied to keep devices performing optimally Device Installation & Setup Coordination with the Installation Team to deploy RPM devices (e.g., sensors, monitors, software systems, etc) at healthcare facilities Ensuring proper device calibration, pairing, and network connectivity Performing initial setup tests to verify full functionality before leaving the site Compliance & Safety Adherence Compliance with HIPAA regulations and company policies to ensure patient dataprivacy. Adherence to safety protocols when handling medical-grade electronic devices. Verification that devices meet hospital infection control standards before and after installation. Maintenance of relevant certifications (e.g., CNA, Paramedic, MA) as required for compliance and safety. Documentation & Reporting Log all installation, troubleshooting, and repair activities in the system. Timely reporting of recurring issues to engineering or product teams for improvement. Maintenance of detailed service logs, customer interaction records, and resolution statuses. Inventory & Maintenance Management Maintain an inventory of devices, replacement devices, and peripherals. Track device deployment, retrievals, and replacements in the system. Ensure proper storage and transportation of devices to prevent damage. Communication Coordination Coordination with clinical, install and technical support, engineering, product and logistics teams to ensure seamless service execution. Providing actionable feedback to product development teams based on field observations. Relaying customer complaints and suggestions to higher management for resolution and process improvement. Certifications & Skills: Certifications such as CNA, Paramedic, or Medical Assistant (MA) - At least 1 is required. Valid driver's license and willingness to travel frequently. Experience: Minimum 2-3 years' experience in clinical coordination, medical device installation, or healthcare technology support. Experience working in healthcare environments, preferably skilled nursing facilities. Skills & Competencies: This role requires frequent travel within assigned regions. Strong clinical knowledge and familiarity with healthcare workflows and medical devices. Excellent communication and interpersonal skills. Ability to train and guide clinical staff effectively. Strong troubleshooting and technical problem-solving skills. Attention to detail and ability to maintain accurate records. Ability to work independently in the field while managing multiple priorities. About Dozee (******************* Vision & MissionSave Million lives with Health AI Dozee is India's leading AI-Powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS). A solution that continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. A "Made in India for the World" solution, Dozee has pioneered the world's first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient safety and care by enhancing outcomes and reducing costs. Dozee is adopted by 300+ hospitals and monitors 16000+ beds across 4 countries. Dozee has monitored over 1 Mn Patients, Delivered 35000+ Life Saving Alerts and Saved 10 Mn+ Nursing Hours. VideosScience Behind Dozee : Ballistocardiography & Artificial Intelligence100 Dozee deliver 144 life saving alerts and INR 2.7 Cr of saving - Sattva StudyDozee saves life of a mother at home Leading Healthcare Game changers work with DozeeIntroducing Dozee VSDozee Shravan - A clinical grade RPM service Dozee in News: Bloomberg - Oct 21, 2024From AI Beds to Remote ICUs, Startups are plugging India's health GapsNews18 - Oct 26, 2024Now, You Can Remotely Monitor Your Loved Ones in Hospital With Bengaluru Start-Up's 'Shravan'Analytics India Magazine - Oct 29, 2024Dozee Harness AI for Personalised Patient CareET HealthWorld - Sep 16, 2024We trust AI everyday - From Google Maps to Smartphones, So why not use it to enhance patient safety in healthcare?BW healthcareworld - Oct 29, 2024Dozee's AI-Powered System Predicts Patient Deterioration 16 Hours in Advance - A tertiary care hospital study published in JMIR, validated Dozee's Early Warning System (EWS), showing it identified 97% of deteriorating patients, provided alerts ~19 hours in advance, and generated 5x fewer alerts, reducing alarm fatigue and improving patient outcomes.- A study at King George Medical University, Lucknow, and published in Frontiers in Medical Technology demonstrated that Dozee's automation can potentially save 2.5 hours of nursing time per shift, improving workflow efficiency and allowing more focus on patient care.- A study on remote patient monitoring in general wards published in Cureus found that 90%+ of healthcare providers reported improved care and patient safety, 74% of patients felt safer, and there was a 43% increase in time for direct patient care.- Research by Sattva, an independent consulting firm, demonstrates Dozee's substantial impact: for every 100 Dozee-connected beds, it can save approximately 144 lives, reduce nurses' time for vital checks by 80%, and decrease ICU average length of stay by 1.3 days. Key HighlightsFounded : October, 2015Founders : Mudit Dandwate, Gaurav ParchaniHeadquarters : Bangalore, India \u007C Houston, USA \u007C Dubai, UAEKey Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures, Temasek Foundation, Horizons VenturesStage : Series A+Team Strength : 280+Business : Providing Continuum of care with AI-powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and HomeCertifications & Accreditations : ISO13485:2016 Certified, ISO27001:2022 Certified, CDSCO Registered, FDA510K Cleared for the flagship product Dozee Vitals Signs (VS) measurement system and SOC2 Type II CertifiedAchievements- Forbes India 30 under 30- Forbes Asia 100 to Watch- Times Network - India Health Awards 2024 for AI innovation in Bharat Healthcare tech- BML Munjal Award for Business Excellence using Learning and Development- FICCI Digital Innovation in Healthcare Award- Anjani Mashelkar Inclusive Innovation Award Marico Innovation For India Award To know more about life@dozee, click here. Disclaimer: Dozee is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.” Dozee does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Dozee will not tolerate discrimination or harassment based on any of these characteristics We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Posting Date 12/09/2025 6770 Perimeter Dr, Dublin, Ohio, 43016, United States of America DaVita is hiring a Dialysis Clinical Coordinator (Experienced Dialysis RN) to lead outpatient dialysis care for patients with end-stage renal disease. In this role, you'll oversee treatment, guide clinical staff, and ensure the highest standards of care and safety. Key Responsibilities: * Operational Hours: MWF 4:00am - 4:00pm, TTHS 5:00am - 3:00pm * Typical week 3 - 4 days, 10-12 hour shifts * Clinic has 12 chairs with 1 RN and 2 techs per shift (2 shifts per day) * Coordinate patient care plans and monitor outcomes * Supervise clinical staff, including PCTs * Ensure safe, compassionate dialysis delivery * Build long-term relationships with patients and families * Work in a fast-paced, team-oriented environment Requirements: * Active Ohio RN license and CPR certification * 18+ months RN experience, including 6+ months dialysis * Charge RN readiness approval required * ADN required; BSN preferred * ICU, ER, or Med/Surg experience preferred * CNN/CDN certification a plus * Basic computer skills (MS Word, Outlook) * Flexible schedule, including weekends and holidays What We Offer: * Medical, dental, vision, 401(k) match * PTO and PTO cash-out * Paid training and development * Family and mental health support (Headspace, EAP, child/elder care) Ready to lead and make a difference? Apply now. #LI-FV1 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

Temporary Description The Clinic Coordinator ensures the medical team is prepared to deliver safe, high-quality care, while supporting staff and volunteers so campers can have a fun, empowering, and medically safe experience. The Medical Team ensures a physically, mentally, and emotionally safe environment by delivering quality medical care and psychosocial support. This team caters to the specific diagnoses we serve by welcoming talented volunteer doctors, nurses, and specialists to support our campers each session. Prioritizing safety for all, we follow established policies and procedures, safety protocols, and emergency preparedness guidelines. Responsibilities: Attend Seasonal Staff Training (May 18-29, 2026) Manage reception duties in the WellNest, including camper intake/greeting, phone coverage, visitor arrival/departure, and housekeeping tasks Perform administrative duties including office supply inventory, camp preparation, file organization, and data entry Serve as communication hub with the Big Red Barn and all other camp teams Coordinate in-camp transportation needs Fill role on the emergency staffing table as needed Requirements Required Skills, Qualifications & Experience Ability to quickly and effectively prioritize tasks and clinical space needs in a fast paced environment Demonstrate flexibility, creative problem-solving skills, and ability to work collaboratively with others Understand the importance of professionalism and confidentiality Demonstrated systems-based organizational skills and attention to detail Ability to live on site (housing and meals provided during sessions) Preferred Skills, Qualifications & Experience Administrative Experience Medical Field Experience (Nursing student, etc.) preferred Valid Driver's License Expectations & Requirements for all Flying Horse Farms Staff We live our Values. We are each responsible for knowing our values and nurturing our culture: We are All In. We demonstrate a willingness to do what it takes to get the job done, we are supportive and loyal, show up present and ready and we are passionate about "Campers First." We have an Attitude of Optimism. We find what is working and make more of that happen, demonstrate adaptability within ambiguity, spread joy and hope and ensure everyone we interact with feels "Welcomed Home." We are Trustworthy. We are consistent, dependable, steady, truthful and operate with transparency, take ownership for our work and "See the Best" in others. We Take Initiative. We are driven, work towards goals with fortitude, pay attention to details and find innovative solutions with "Fearless is Free" attitudes. Salary Description $3,500 for the summer

Job DescriptionDescription: The Clinic Coordinator ensures the medical team is prepared to deliver safe, high-quality care, while supporting staff and volunteers so campers can have a fun, empowering, and medically safe experience. Team Overview: The Medical Team ensures a physically, mentally, and emotionally safe environment by delivering quality medical care and psychosocial support. This team caters to the specific diagnoses we serve by welcoming talented volunteer doctors, nurses, and specialists to support our campers each session. Prioritizing safety for all, we follow established policies and procedures, safety protocols, and emergency preparedness guidelines. Responsibilities: Attend Seasonal Staff Training (May 18-29, 2026) Manage reception duties in the WellNest, including camper intake/greeting, phone coverage, visitor arrival/departure, and housekeeping tasks Perform administrative duties including office supply inventory, camp preparation, file organization, and data entry Serve as communication hub with the Big Red Barn and all other camp teams Coordinate in-camp transportation needs Fill role on the emergency staffing table as needed Requirements: Required Skills, Qualifications & Experience Ability to quickly and effectively prioritize tasks and clinical space needs in a fast paced environment Demonstrate flexibility, creative problem-solving skills, and ability to work collaboratively with others Understand the importance of professionalism and confidentiality Demonstrated systems-based organizational skills and attention to detail Ability to live on site (housing and meals provided during sessions) Preferred Skills, Qualifications & Experience Administrative Experience Medical Field Experience (Nursing student, etc.) preferred Valid Driver's License Expectations & Requirements for all Flying Horse Farms Staff We live our Values. We are each responsible for knowing our values and nurturing our culture: We are All In. We demonstrate a willingness to do what it takes to get the job done, we are supportive and loyal, show up present and ready and we are passionate about "Campers First." We have an Attitude of Optimism. We find what is working and make more of that happen, demonstrate adaptability within ambiguity, spread joy and hope and ensure everyone we interact with feels "Welcomed Home." We are Trustworthy. We are consistent, dependable, steady, truthful and operate with transparency, take ownership for our work and "See the Best" in others. We Take Initiative. We are driven, work towards goals with fortitude, pay attention to details and find innovative solutions with "Fearless is Free" attitudes.

**Job Purpose:** The Senior Clinical Research Associate I (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Plans, coordinates, and implements newborn hemoglobin screening and testing follow-up and hemoglobinopathy counseling services in a multi-county service region defined by the Ohio Department of Health (ODH), Bureau for Children with Medical Handicaps (CMH), Sickle Cell Services Program. Job Description: Essential Functions: Tracks and conducts follow-up on all newborns identified with a positive or potentially positive hemoglobin trait or disease result via the ODH Newborn Screening (NBS) Program and other referral sources to assure confirmation of results and hemoglobinopathy counseling services disease education and/ or referral to specialized medical teams and resources for diagnostic, preventive and evaluative management of sickling hemoglobinopathies. Coordinates and facilitates education sessions and reciprocal referrals for hemoglobinopathy counseling services in conjunction with primary care providers, Regional Hematology-Oncology Centers and Regional Comprehensive Genetic Centers. Serves as a liaison and resource consultant regarding hemoglobinopathies, newborn screening and hemoglobinopathy counseling services to regional agencies and organizations, health and allied health professionals and providers, patients or consumers, and the public. Participates in outreach strategies to increase patient referrals, compliance and access to comprehensive sickle cell services in conjunction with Regional Hematology-Oncology Centers. Assists with the preparative writing and submission of Regional Sickle Cell Progam (RSCP) reports and grant proposals. Maintains records system and data/statistics on RSCP newborn screening and hemoglobinopathy counseling services for ODH data collection, program evaluation and other reporting requirements. Education Requirement: Bachelor's Degree in relevant field, required. Licensure Requirement: Valid Ohio driver's license and proof of auto insurance as required by hospital policy and position-specific requirements. Must pass motor vehicle background inspection, insurance eligibility, driving qualifications, and training set forth by Nationwide Children's Hospital and maintain qualification of insurance guidelines. Skills: Working knowledge of hemoglobinopathies and/or chronic disease. Must continuously advance knowledge in the area of hemoglobinopathies, newborn screening, hemoglobinopathy counseling and culturally and linguistically appropriate service delivery. Demonstrated oral and written communication skills. Self-motivated with the ability to function independently. Must be able to work closely with diverse populations and professionals from other disciplines. Must be able to develop and maintain collaborative relationships with pediatric and adult hematology and primary care service providers in the region and work as part of an integrated team. Experience: Two years of college intern or professional experience with social service agency, community-based program or health related institution, required. Training or experience in counseling techniques, required. Physical Requirements: OCCASIONALLY: Decision Making, Driving motor vehicles (work required) *additional testing may be required, Flexing/extending of neck, Lifting / Carrying: 0-10 lbs, Walking FREQUENTLY: Problem solving CONTINUOUSLY: Audible speech, Computer skills, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Repetitive hand/arm use, Seeing - Far/near, Sitting "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. Summary: The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. Responsibilities And Duties: Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. Minimum Qualifications: Associate's Degree Additional Job Description: Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) Work Shift: Day Scheduled Weekly Hours : 40 Department Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

Company Overview : Dozee Health AI is the pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India's no. 1 RPM Company. We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you'll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models Role Overview: The Field Clinical Coordinator plays a key role in supporting healthcare professionals,primarily nurses, to ensure the effective utilization of clinical systems and devices. This position involves facilitating seamless device installations, guiding staff on proper usage and best practices, and providing on-site support for technical troubleshooting and operational issues Responsibilities Training & Assistance for Nurses & Care Teams Deliver hands-on training to nurses and caregivers on device operation, maintenance, and interpretation of readings Provide on-site and remote support to address common device and system issues Ensure compliance with facility protocols and company guidelines during device use Coordinate and facilitate telehealth assessments in collaboration with Nurse Practitioners (NPs) Support nursing teams in performing basic patient reviews for stable patients Maintain strong clinical understanding, communication, and bedside interaction skills On-Site Troubleshooting & Technical Support Respond promptly to service requests to resolve device malfunctions or connectivity issues Diagnose and address minor hardware or software problems, escalating complex cases to the technical support team Replace or maintain faulty devices to ensure uninterrupted clinical operations Ensure all necessary firmware updates are applied to keep devices performing optimally Device Installation & Setup Coordination with the Installation Team to deploy RPM devices (e.g., sensors, monitors, software systems, etc) at healthcare facilities Ensuring proper device calibration, pairing, and network connectivity Performing initial setup tests to verify full functionality before leaving the site Compliance & Safety Adherence Compliance with HIPAA regulations and company policies to ensure patient dataprivacy. Adherence to safety protocols when handling medical-grade electronic devices. Verification that devices meet hospital infection control standards before and after installation. Maintenance of relevant certifications (e.g., CNA, Paramedic, MA) as required for compliance and safety. Documentation & Reporting Log all installation, troubleshooting, and repair activities in the system. Timely reporting of recurring issues to engineering or product teams for improvement. Maintenance of detailed service logs, customer interaction records, and resolution statuses. Inventory & Maintenance Management Maintain an inventory of devices, replacement devices, and peripherals. Track device deployment, retrievals, and replacements in the system. Ensure proper storage and transportation of devices to prevent damage. Communication Coordination Coordination with clinical, install and technical support, engineering, product and logistics teams to ensure seamless service execution. Providing actionable feedback to product development teams based on field observations. Relaying customer complaints and suggestions to higher management for resolution and process improvement. Certifications & Skills: Certifications such as CNA, Paramedic, or Medical Assistant (MA) - At least 1 is required. Valid driver's license and willingness to travel frequently. Experience: Minimum 2-3 years' experience in clinical coordination, medical device installation, or healthcare technology support. Experience working in healthcare environments, preferably skilled nursing facilities. Skills & Competencies: This role requires frequent travel within assigned regions. Strong clinical knowledge and familiarity with healthcare workflows and medical devices. Excellent communication and interpersonal skills. Ability to train and guide clinical staff effectively. Strong troubleshooting and technical problem-solving skills. Attention to detail and ability to maintain accurate records. Ability to work independently in the field while managing multiple priorities. About Dozee (******************* Vision & MissionSave Million lives with Health AI Dozee is India's leading AI-Powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS). A solution that continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. A "Made in India for the World" solution, Dozee has pioneered the world's first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient safety and care by enhancing outcomes and reducing costs. Dozee is adopted by 300+ hospitals and monitors 16000+ beds across 4 countries. Dozee has monitored over 1 Mn Patients, Delivered 35000+ Life Saving Alerts and Saved 10 Mn+ Nursing Hours. VideosScience Behind Dozee : Ballistocardiography & Artificial Intelligence100 Dozee deliver 144 life saving alerts and INR 2.7 Cr of saving - Sattva StudyDozee saves life of a mother at home Leading Healthcare Game changers work with DozeeIntroducing Dozee VSDozee Shravan - A clinical grade RPM service Dozee in News: Bloomberg - Oct 21, 2024From AI Beds to Remote ICUs, Startups are plugging India's health GapsNews18 - Oct 26, 2024Now, You Can Remotely Monitor Your Loved Ones in Hospital With Bengaluru Start-Up's 'Shravan'Analytics India Magazine - Oct 29, 2024Dozee Harness AI for Personalised Patient CareET HealthWorld - Sep 16, 2024We trust AI everyday - From Google Maps to Smartphones, So why not use it to enhance patient safety in healthcare?BW healthcareworld - Oct 29, 2024Dozee's AI-Powered System Predicts Patient Deterioration 16 Hours in Advance - A tertiary care hospital study published in JMIR, validated Dozee's Early Warning System (EWS), showing it identified 97% of deteriorating patients, provided alerts ~19 hours in advance, and generated 5x fewer alerts, reducing alarm fatigue and improving patient outcomes.- A study at King George Medical University, Lucknow, and published in Frontiers in Medical Technology demonstrated that Dozee's automation can potentially save 2.5 hours of nursing time per shift, improving workflow efficiency and allowing more focus on patient care.- A study on remote patient monitoring in general wards published in Cureus found that 90%+ of healthcare providers reported improved care and patient safety, 74% of patients felt safer, and there was a 43% increase in time for direct patient care.- Research by Sattva, an independent consulting firm, demonstrates Dozee's substantial impact: for every 100 Dozee-connected beds, it can save approximately 144 lives, reduce nurses' time for vital checks by 80%, and decrease ICU average length of stay by 1.3 days. Key HighlightsFounded : October, 2015Founders : Mudit Dandwate, Gaurav ParchaniHeadquarters : Bangalore, India | Houston, USA | Dubai, UAEKey Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures, Temasek Foundation, Horizons VenturesStage : Series A+Team Strength : 280+Business : Providing Continuum of care with AI-powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and HomeCertifications & Accreditations : ISO13485:2016 Certified, ISO27001:2022 Certified, CDSCO Registered, FDA510K Cleared for the flagship product Dozee Vitals Signs (VS) measurement system and SOC2 Type II CertifiedAchievements- Forbes India 30 under 30- Forbes Asia 100 to Watch- Times Network - India Health Awards 2024 for AI innovation in Bharat Healthcare tech- BML Munjal Award for Business Excellence using Learning and Development- FICCI Digital Innovation in Healthcare Award- Anjani Mashelkar Inclusive Innovation Award Marico Innovation For India Award To know more about life@dozee, click here. Disclaimer: Dozee is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.” Dozee does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Dozee will not tolerate discrimination or harassment based on any of these characteristics

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Dr. Kristen Fox seeks a full-time Clinical Research Coordinator II (CRC II) to join her research program focused on preventing risky health behaviors (e.g., e-cigarette use) among adolescents with congenital heart disease. The CRC II will support an NIH-funded randomized clinical trial evaluating a mobile health intervention, and contribute to studies examining health behaviors, psychosocial functioning, and healthcare experiences in adolescents and young adults with congenital heart disease. Research methods include clinical trials, surveys, medical record reviews, and qualitative interviews. This position is grant-funded and is fully in-person. Flexibility to work some evenings/weekends for participant recruitment and data collection is required. The position is available immediately. Summary: Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC's to ensure consistency in study management activities. Job Description: Essential Functions: Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices. Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate; Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination. Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection, Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF's) and ensures CRF's are completed prior to monitor visits. Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training. Alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder. Assists the principal investigator in the preparation of scientific publications and grant proposals. Education Requirement: Associate's degree or equivalent work-related experience, required. BA/BS, preferred. Licensure Requirement: (not specified) Certifications: CRA/CRC certification, preferred. Skills: Understanding of medical terminology and clinical trials preferred. Working knowledge of PCs and word processing and data management software. Demonstrated analytical skills with accuracy and attention to detail. Excellent verbal and written communication skills. Goal-oriented and self-directive, ability to manage complex projects independently. Strong organizational and interpersonal skills. Ability to actively participate as a team player. Experience: Eighteen months experience in clinical research or health care field, required. Physical Requirements: OCCASIONALLY: Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near Additional Physical Requirements performed but not listed above: (not specified) "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. ** Summary:** The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. **Responsibilities And Duties:** Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Minimum Qualifications:** Associate's Degree **Additional Job Description:** Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) **Work Shift:** Day **Scheduled Weekly Hours :** 40 **Department** Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

Dr. Kristen Fox seeks a Clinical Research Program Coordinator to join her research program on health behaviors, psychosocial functioning, and healthcare experiences of adolescents and young adults with congenital heart disease. The candidate will play an integral role in supporting Dr. Fox's program of research, including implementing a NIH-funded randomized clinical trial evaluating a mobile health intervention. Key duties include coordinating trial start-up activities, overseeing day-to-day operations of the trial, and supervising research coordinators. Opportunities exist to contribute to research products. This position requires in-person work. Flexibility to work some evenings/weekends for recruitment and data collection as needed is required. The position is available immediately. Summary: Coordinates and manages the department/center's research portfolio. Maintains working knowledge of projects in process as well as funded projects including grant budgets and IRB protocols. Coordinates subcontracts with other sites and the Sponsored Projects Office, develops and implements processes across multiple study sites, and maintains documents to ensure effective, efficient and compliant project progress. Job Description: Essential Functions: Responsible for administrative management, organization of, and participation in program meetings and teleconferences, including scientific meetings with corporate and non-profit partners, teaching conferences, grand rounds, journal club, research seminars, and CME programs. Works with Sponsored Projects Officer to manage program and project funds and dissemination of funding to collaborations sites in addition to the subcontracts with other sites. Provides funding opportunity notifications to PI's. Collaborates with department/center investigators in the development of IRB protocols, grant submissions and scientific publications. Coordinates personnel needs for the program and projects; oversees and organizes training. Track projects and initiatives to ensure they move forward based on both timelines and budget; report to PI when progress is lacking and identifies needed action. May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.). Manages and oversees IRB process for program projects and associated sites, ensuring sites are submitting accurate and timely IRB submissions, and maintain associated regulatory documents. Helps facilitate creation of source documents that ensure systematic data collection and/or aid in protocol execution and management and record keeping. Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects. Provides monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations QA process implementation, maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols. Work with principal investigators at each site to establish multi-site monitoring plans for investigator-initiated projects. Education Requirement: Bachelor's degree preferred or Associate degree with two years clinical research experience or project management experience. Certifications: ACRP or SOCRA certification, preferred. Skills: Demonstrated leadership skills Strong organizational skills Exceptional interpersonal, written and verbal communication Ability to filter information, discern importance and initiate plan for project completion Self-directed, results driven with the ability to manage workload. Ability to work independently and as part of a team. Working knowledge of data management software. Experience: Two years clinical research experience or project management experience. Physical Requirements: OCCASIONALLY: Bend/twist, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Reaching above shoulder, Squat/kneel FREQUENTLY: Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near Additional Physical Requirements performed but not listed above: (not specified) "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. ** Summary:** The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. **Responsibilities And Duties:** Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Minimum Qualifications:** Bachelor's Degree (Required) **Additional Job Description:** required from a four year college or university **SPECIALIZED KNOWLEDGE** Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) **DESIRED ATTRIBUTES** One year of relevant work or academic experience preferred Prior experience in a medical environment preferred Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification) One or more years of direct human subjects research Clinical knowledge in assigned therapeutic area or program **MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS** **Study Planning and Coordination** Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carryout the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations. Assist with recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participate in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. After closeout visits have been conducted, prepares study documents for archiving according to timelines. Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. **Patient Care** Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe and report adverse events and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. **Quality and Compliance** Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. **Reporting** Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. **Communication** Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Work with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. **Other** Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Work Shift:** Day **Scheduled Weekly Hours :** 40 **Department** Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment