Clinical research associate jobs in Columbus, OH - 22 jobs

**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.

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. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. 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_

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"

About the Role The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You'll Be Doing Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract. Acts as a liaison between sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria. Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational Product accountability for accurate compliance. Collects, processes and ships blood/urine specimens at scheduled times. Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study specific procedures, including but not limited to ECG's, vital signs, height, weight, injections etc. within his/her scope of practice. Collect, compile and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol. Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance. Contacts outside health care providers and communicates with subjects to obtain follow up information. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Ensures filing and maintenance of all regulatory documents. Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned. What We Expect from You Associates or Bachelor's Degree from an accredited college or university. Good Clinical Practice (GCP) Certificate International Air Transport Association (IATA) Certificate CCRC certification through an accredited organization (ACRP/SoCRA) is required 2-3 years related Research experience Preferred. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Travel Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected. What We are Offer You At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters” Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more. About US Urology Partners U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy. U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during 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.

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

Lincoln Care and Rehab in Wichita, KS is looking to hire a full-time MDS/Clinical Reimbursement Coordinator to join our team. Are you looking for a career with a health care company that will value you? Do you want to be part of a dynamic and caring clinical team? If so, please read on! This nursing position earns a competitive salary of $80,000 - $84,000 per year. We also provide comprehensive benefits, including medical, dental, vision, short- and long-term disability, a flexible spending account (FSA), a 401(k) plan, paid time off (PTO), life insurance, continuing education unit (CEU) reimbursement, and daily pay options. If this sounds like the right opportunity in health care for you, apply today! As an MDS/Clinical Reimbursement Coordinator, The MDS Coordinator is responsible for the timely and accurate completion of the Federal and State assessment tools but may also be called upon to perform duties of an RN, if needed. This position requires an understanding of the MDS rules and regulations as described in the MDS User's Manual, including item coding, RAPS, CAA's, Care Planning, electronic submission, scheduling, PPS including knowledge of MDS submission process, final validation reports, and an understanding of Medicare rules and regulations including coverage, benefit periods, certification, 30 Day rule. you will intake all processed forms, including but not limited to, order sheets, doctor notes, pharmacy recommendations, order summaries and lab results and scanning them into electronic form to upload each document into the applicable resident's electronic medical record. WORK SCHEDULE This full-time health care position works typically Monday-Friday but is subject to facility needs. QUALIFICATIONS FOR A LICENSED PRACTICAL NURSE (LPN) Current RN licensure with the KS Board of Nursing Current CPR certification 1-2 years of experience as an MDS Coordinator Good organization skills Experience with 3.0, PPS, and Case Mix Ability to pass license check, background check and drug screen Ability to maintain confidentiality and comply with all HIPPA regulations Desire to work with the elderly ARE YOU READY TO JOIN OUR TEAM? If you feel that you would be right for this rehabilitation nursing job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you! ************************************************

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.

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

The Senior Clinical Research Associate (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 the Sponsor's 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. **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 the Sponsor's 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 Site Care Partner 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 Site Care Partner 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 the Sponsor's credibility, scientific leadership and in order to facilitate their 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 **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#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.

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_

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:** 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

**Job Purpose:** The Senior Clinical Research Associate (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.

Emergency Services at Nationwide Children's Hospital includes a Level I Pediatric Trauma Center and a 24/7 Pediatric Emergency Department staffed by pediatric emergency medicine specialists. The department provides advanced life support, resuscitation, and care for acute medical and surgical conditions. As part of the Pediatric Emergency Care Applied Research Network (PECARN), we lead federally funded research in pediatric emergency medicine. Current studies focus on trauma imaging, massive transfusion, asthma-induced critical illness, seizure management, airway techniques, sickle cell crises, and sepsis treatment. Summary: Coordinates project activities, schedules meetings, communicates with stakeholders, tracks progress, and ensures timely completion of tasks. Job Description: Essential Functions: Assists with the development of project plans and timelines to ensure tasks are completed on schedule. Coordinates project meetings and communicates updates to team members. Monitors project progress alongside project manager and identifies any potential risks or issues. Collaborates with internal and external stakeholders to gather requirements and feedback. Prepares and maintains project documentation and reports. Assists in budget tracking and resource allocation for the project. Contributes to projects and serves as a subject matter expert in area of responsibility. Education Requirement: Bachelor's Degree in relevant field, or equivalent experience, required. Licensure Requirement: (not specified) Certifications: (not specified) Skills: Excellent interpersonal, oral, and written skills. Detail-oriented and organized, with the ability to multitask and efficiently provide time management. Collaborative and team-oriented with the ability to work well independently. Experience: One year of program or project support, required. Physical Requirements: OCCASIONALLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Climb stairs/ladder, Cold Temperatures, Communicable Diseases and/or Pathogens, Driving motor vehicles (work required) *additional testing may be required, Electricity, Flexing/extending of neck, Fume /Gases /Vapors, Hand use: grasping, gripping, turning, Hot Temperatures, Lifting / Carrying: 41-60 lbs, Lifting / Carrying: 61-100 lbs, Loud Noises, Machinery, Patient Equipment, Power Tools, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Reaching above shoulder, Repetitive hand/arm use, Squat/kneel, Standing, Walking, Working at Heights, Working Outdoors FREQUENTLY: Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs CONTINUOUSLY: Audible speech, Color vision, Computer skills, Decision Making, Depth perception, Hearing acuity, Interpreting Data, Lifting / Carrying: 0-10 lbs, Peripheral vision, Problem solving, Seeing - Far/near, Sitting 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"

With supervision, CRCs engage in the enrollment, recruitment, retention of research participants, and other tasks as needed. CRCs conduct clinical interviews for children and adults, obtain mental health history, and review reported suicidal ideation/behavior to determine if further intervention is indicated. Studies focus on youth mental health, including school-based programs. Travel to school research sites required. Bachelor's degree in a social science field and previous research experience or work in the mental health field preferred. Effective customer service, communication, organization, and attention to detail required. Bilingual Spanish/English preferred. Typical hours: Mon-Fri 8a-4:30p, one late day/week 12p-8:30p. Hours subject to change dependent on project needs. Summary: The Clinical Research Coordinator I manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities. Job Description: Essential Functions: Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects' rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate. Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures. Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours. Completes screening sheets and recruitment logs. 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. Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I. Adheres to departmental quality control guidelines. Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF's are completed prior to monitoring visits. Maintains regulatory binder and documents. Education Requirement: Associates degree, STNA, PCA, LPN, MA or equivalent work-related experience required. BA/BS preferred. Licensure Requirement: (not specified) Certifications: Ability to obtain CRA/CRC certification in a timely manner. Skills: Understanding of medical terminology and clinical research 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 Strong organizational and interpersonal skills. Ability to actively participate as a team player. Experience: Previous experience in clinical research or health care related field preferred. Physical Requirements: OCCASIONALLY: Cold Temperatures, 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"

Works with the study physician to ensure all patients involved in a clinical research trial are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring patient care is not compromised while participating in the trial. Manages all elements of a clinical research trial in order to meet all protocol obligations while following applicable regulations; Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures. Job Description: Essential Functions: Plans, implements, educates and evaluates care plan using Evidence-Based Practices in accordance with the requirements of the study protocol Provides nursing care using a Family Centered approach throughout their clinical study participation while maintaining quality and safety as a priority. Delegates, directs, oversees and provides developmentally appropriate patient care. Practices professional nursing and promotes patient advocacy in accordance with the ANA Code of Ethics for Nurses and maintains a current Ohio Nursing License Collaborates effectively and communicates patient care needs/expectations/priorities related to clinical trial participation to all involved care providers including unit nursing staff, attending physician, ancillary service providers (radiology, cardiology, physical therapy, pharmacy, etc.) to facilitate positive patient outcomes both in clinical care and in clinical trial participation Completes and manages all procedural, data, regulatory and training elements associated with clinical research project implementation, execution and close out to ensure participant safety, data integrity and compliance with all applicable regulations. Education Requirement: BSN or Associate's Degree with commitment to obtain BSN within 5 years of hire, required. Licensure Requirement: Registered Nurse in the State of Ohio, required. Certifications: CPR, required. Obtain and maintain NRP and PALS certification as determined by management. Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators. Skills: Demonstrated proficiency in clinical nursing skills, (i.e.: venipuncture, IV starts and injections); Understanding of medical terminology, clinical trials preferred Working knowledge of PCs, word processing, and data management software Strong verbal, written, interpersonal communication Goal-oriented; self-directive, initiation, self-motivation, creativity, flexibility Excellent organizational, attention to detail and prioritization skills Ability to actively participate as a team player Experience: Two years in clinical research nursing, required. Physical Requirements: OCCASIONALLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Climb stairs/ladder, Cold Temperatures, Color vision, Communicable Diseases and/or Pathogens, Depth perception, Driving motor vehicles (work required) *additional testing may be required, Electricity, Flexing/extending of neck, Fume /Gases /Vapors, Hand use: grasping, gripping, turning, Hot Temperatures, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Lifting / Carrying: 41-60 lbs, Lifting / Carrying: 61-100 lbs, Loud Noises, Patient Equipment, Peripheral vision, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Reaching above shoulder, Seeing - Far/near, Squat/kneel FREQUENTLY: Decision Making, Interpreting Data, Problem solving, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Hearing acuity, Repetitive hand/arm use, Sitting 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"

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"