Research Coordinator jobs at NYU Lutheran Medical Center

Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements. Essential functions of the job include but are not limited to: Primary clinical point of contact with the client Collaborate with PM on monthly invoicing and variance management of clinical budget Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings Generate potential site list from key stakeholders and drive site feasibility process Identify potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment Develop and finalize the country recruitment/retention strategy Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate Support in planning and conducting investigator meetings Review and/or approve of IP release packages Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate Responsible for eTMF implementation and management Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits Work closely with PM for project-specific resourcing issues Escalate pertinent CRA performance and site compliance issues when necessary Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines Manage processes for investigational product (IP) including drug accountability and reconciliation When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed Support business development and marketing activities as appropriate May negotiate site budget and investigator contract with support from the legal department and/or site contracts group May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM May perform clinical data review of patient profiles, data listings and summary tables, including query generation May have line management responsibilities Performs other duties as assigned by management Qualifications: Minimum Required: Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience Preferred: Advanced degree Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Excellent communication and interpersonal skills to effectively interface with others in a team setting Excellent organizational skills, attention to detail, and a customer service demeanor Ability to travel domestically and internationally including overnight stays Competencies: Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement Working knowledge of clinical management techniques and tools Direct work experience in a cross-functional environment Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics Proven experience in planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a team Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Excellent presentation, verbal and written communications skills In depth proven experience in pharmaceutical and/or device research required Demonstrated successful independent negotiation and conflict management strategies Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$113,900-$187,800 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

We are hiring Physical Therapists at Medpace! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a physical therapy/kinesiology background who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! Positions are office based in Cincinnati-OH, Dallas-TX, or Denver-CO. MEDPACE CRA TRAINING PROGRAM (PACE) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: * PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. * PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. * To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to-day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check, * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or science related field; degree in Physical Therapy or Kinesiology preferred; * Ability to travel 60-70% to locations nationwide is required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the Associate Director, Clinical Operations and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Key Clinical Operations role: ensures that delegated components of clinical trials are executed to expected and specified quality standards Expands basic knowledge of clinical trials operations and scientific principles and objectives of EyePoint's clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others Builds best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations Authors/ reviews/ contributes to clinical study documents Reviews and approves study related plans generated by Clinical CROs and vendors Provides input as the subject matter expert for the study during regulatory inspections Executes the clinical study in accordance with the project clinical development strategy and timelines Contributes to the review of international study documents (e.g study protocol, ICF, etc.) and responsible for their local adaptation when necessary. Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines Responsible for oversight of identification and selection of investigator sites Responsible for planning and conducting investigator's meetings in cooperation with the respective departments Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team Collaborates with the cross functional team on selection and management of clinical vendors Manages escalation of study related issues and communicates as appropriate with management and other R&D functions Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight Trains and manages CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements Monitors the status of clinical data collection of assigned clinical studies Ensures preparation for regulatory agency inspections by developing and executing readiness plans, managing documentation, and facilitating cross-functional collaboration to maintain compliance with GMPGDP standards May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact Responsible for the availability and tracking all relevant study information/ study metrics Oversees the resolution of data quality issues Reviews correspondence and monitoring reports relating to the study Evaluates CRO and vendor performance for future work Provides periodic status reports regarding study timelines, accruals, etc. to EyePoint Management as requested Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable Requests and critically evaluates proposals and change orders from CROs and vendors Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities Qualifications Primary skills and knowledge required include, but are not limited to the following: Preferred Qualifications Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred Knowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research. Ophthalmology experience strongly preferred Up to 20% domestic and/or international travel may be required Previous experience directing inspection readiness strongly preferred Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required Global clinical trial experience and the ability to lead/manage more than one clinical trial Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands Ability to work independently and take initiative Ability to work/communicate successfully within a cross-functional team Strong knowledge of applicable computer and project management software packages Familiarity with financial budgeting and forecasting or reporting Respectfully challenges current practices, decisions, or ideas to promote quality and efficiency Excellent written and oral communication skills Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization Level of Education Required: Bachelor's degree at least preferred in Scientific/health care related field. Number of Years of Experience in the Function and in the Industry: 5+ years' experience working in clinical operations within a pharmaceutical company or CRO or similar organization Experience of at least 3 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $146,260.00/Yr. Max USD $184,713.00/Yr.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Clinical Trial Manager is responsible for the execution of phase 3 clinical studies and data collection. The incumbent reviews, monitors, and adheres to protocols, as well as fulfilling activities related to study completion. The Clinical Trial Manager will interact internally and externally, and with members of a cross-functional study team. Essential Job Functions and Responsibilities: These may include but are not limited to: Provide oversight of late-phase clinical research studies across all functional areas of the drug development process. Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc. Develop the subject recruitment/retention strategy and related initiatives. Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents, including review of site regulatory documents/packages and obtaining of appropriate site insurance. Development of training materials for study team, investigational sites, and vendors. Proactive management of information sharing with key stakeholders using standardized reports and other mechanisms. Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate. Oversee preparation of RFPs and prepares bid templates to facilitate selection of the CROs/vendors. Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed. Acts as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed Perform study risk management and implement mitigations. Identify potential study issues and recommend and implement solutions or corrective actions as needed. Create realistic plans that clearly define goals, milestones, responsibilities and results. Maintain focus on strategic objectives while accomplishing operational goals Make timely, data-driven decisions. Education and Experience: Required: Bachelor's degree required with 7 years of experience of prior clinical operations experience preferably with CRO/small biotech experience. 2 years in a supervisory role. Must be able to travel up to 25% of time, may be higher in accordance with project requirements. Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IXRS and EDC systems. Excellent understanding of drug development process. Able to make appropriate decisions to move the project(s) forward. Effective verbal and written communication skills. Data flow from sites to data processing, review, and resolution. Analysis and report generation. FDA regulatory requirements (i.e. GCPs, CFRs, etc.). Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Study initiation procedures. Ability to exercise judgment and determine appropriate action. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws Salary Range The salary range for this position is: $122,000 - $152,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 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.

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What Clinical Operations does at Worldwide At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the lives of patients. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure that your professional development remains a top priority. We offer a clear career path and development that can lead to Clinical Trial Manager roles. We take pride in our accessible Executive Leadership team, who are equally committed to advancing science and surmounting obstacles to make a difference in the lives of patients around the world. We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial. Experience a world of difference with us at Worldwide! What you will do Responsible for managing the research activities at sites participating in Worldwide's clinical research projects, which are predominantly registries and other types of non-interventional / observational studies Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded Conduct study initiation visits (SIVs) While most of the site management efforts will be performed remotely, will be required to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements What you will bring to the role Excellent interpersonal, oral, and written communication skills in English Superior organizational skills with attention to details Ability to work with little or no supervision Proficiency in Microsoft Office, CTMS and EDC Systems Your experience 5+ years of experience as a Clinical Research Associate 4-year university degree or RN/BSN in Nursing Experience in CNS/Neurology is required, Rare Disease expereince a plus Candidates must reside on the East Coast United States in close proximity to an international airport Willingness to travel regionally required We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Clinical Operations Department does at Worldwide Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience - one you can't get anywhere else, with a team unlike anyone else. At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient's life depends on it - because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. What you will do Responsible for managing the research activities at sites participating in Worldwide's clinical research projects, which are predominantly registries and other types of non-interventional / observational studies Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded Conduct study initiation visits (SIVs) While most of the site management efforts will be performed remotely, will be to ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirement What you will bring to the role Excellent interpersonal, oral, and written communication skills in English Superior organizational skills with attention to details Ability to work with little or no supervision Proficiency in Microsoft Office, CTMS and EDC Systems Your experience 5+ years of experience as a Clinical Research Associate 4-year university degree or RN/BSN in Nursing Willingness to travel We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Job Description Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! As an Assistant Research Coordinator, you will assist the research coordinator (CRC/CCRC) in conducting clinical trials. The research associate is responsible for collecting, processing, storing and handling clinical specimens (as needed), scheduling study subjects for study visits, and collecting, recording, and filing clinical research data. QPS' Story: Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of services, including Early Phase Clinical and Phase II - IV Clinical Research services. The QPS location in Miami, Florida is a multi-specialty research center employing clinical research professionals, including board-certified physicians, in a 32,000 square foot space. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life. Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals. If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website (************ for more information and to see all current openings. The Job Establish good rapport with potential study subjects Clinical data collection such as vital signs, ECG recording, subject height and weight, etc. Laboratory specimen collection and processing (as needed) Timely recordkeeping of completed study visits & procedures in organization's Clinical Trial Management System Review and retrieve medical records Requirements High School diploma or equivalent Minimum one (1) year experience as a Medical Assistant OR have background experience of at least one (1) year in an ancillary or allied health specialty Excellent communication skills. Exceptional telephone skills. A bilingual person in English and Spanish is preferred. Must be flexible with schedule (3pm-11pm shift, & some weekends) Why You Should Apply Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals. Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance. Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance QPS is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.

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_

Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a highly motivated and skilled Senior Clinical Project Manager within our Clinical Operations team who will manage the conduct and execution of one or more clinical trials from study start-up to study closure with support or direction from a Director of Clinical Operations. In this role, you will: Lead all aspects of clinical trial execution for one or more programs from IND through proof-of-concept and pivotal studies Plan and oversee implementation, coordination, and execution of global clinical trials including, but not limited to, oversight of study budgets, financial reporting, and forecasting in collaboration with Clinical Outsourcing Develop and maintain strong relationships with cross-functional study teams, CROs, clinical investigators, and clinical trial stakeholders Manage clinical trial operations and lead study teams, including CROs and vendors, and reporting of start-up, conduct, and close-out activities Ensure compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICH and local regulations The Team You'll Join Reporting to a Director of Clinical Operations, you will be an essential member of the Clinical Operations team within Development. This team is dedicated to ensuring operational excellence across our clinical programs.The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities. The Experience You'll Need Bachelor's degree in a scientific or healthcare-related field 7+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 3+ years experience in a clinical project management role within a biotech organization required Early phase (Phase 1, 2) oncology experience at a biotech/Sponsor is required Demonstrated experience organizing and leading clinical study teams Preferred Skills: proficiency managing timelines, tasks, milestones working in SmartSheet or similar project management software Demonstrated track-record of efficient and effective clinical trial planning and execution, including risk management and mitigation strategies Experience in vendor and CRO selection,management, and oversight Experience managing and tracking study budgets and financials with participation and involvement with invoice and contract review and approvals Experience working closely with data management and clinical teams to set up study systems and ensure quality data collection through monitoring, cleaning and analysis Preferred: CRF development and IRT build experience, knowledge of data listings used for monitoring and cleaning, contribution to data management related plans and specifications Excellent working knowledge of FDA, ICH, GCP regulations and guidelines Willingness and ability to travel to sites, conferences and Recursion offices as needed Working Location & Compensation: This position is ideally based at our office located in New York City, but may also be located in our Salt Lake City headquarters. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role. At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $168,000 to $204,800 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. #LI-DB1 The Values We Hope You Share: We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust. We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action. We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection. We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day. We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together. We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities. Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively. More About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine. Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn. Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in all aspects of the selection process. Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

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

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 clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Operations team in Denmark (candidates can be based anywhere in Denmark). This position will work on a Nordic team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. If you are looking for a stable, consistently, rapidly, developing CRO, Medpace is a great place for you! We are currently seeking full-time, home or office-based Clinical Research Associates to join our energetic Clinical Monitoring team in the Denmark. We offer an exciting career where you can grow further, using your current and and previous expertise. Responsibilities * Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas; * Perform source document verification and case report form review; * Perform regulatory document review; * Conduct study drug inventory; * Perform adverse event and serious adverse event reporting and follow-up; and * Assess patient recruitment and retention. Qualifications * Bachelor of Science in health-related field; * Proven CRA experience of at least 1.5 years independent monitoring experience * Broad knowledge of medical terminology and clinical patient management; * Basic knowledge of drug therapy techniques and clinical research methodologies; * Fluency in local language and excellent English are required. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 50+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive compensation and benefits package * Competitive PTO packages * Structured career paths with opportunities for professional growth * Company-sponsored employee appreciation events * Employee health and wellness initiatives Awards * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Clinical Development & Research - Non-MD **Job Category:** Scientific/Technology **All Job Posting Locations:** Jacksonville, Florida, United States of America **Job Description:** We are searching for the best talent to join our Vision team as a **Staff Clinical Trial Specialist** located in **Jacksonville, FL** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **Purpose:** The Staff Clinical Trials Specialist manages study conduct under the guidance of a senior level manager ensuring that operating procedures and company policies are followed. The Staff Clinical Trial Specialist develops and manages timelines, resourcing, and budget for assigned clinical trials. They build cross-functional support for innovative solutions and facilitate successful study team behavior. They partner with Research & Development and Research Scientists/Clinicians to ensure study results and timelines are met. They maintain relationships externally with strategic partners, monitors, Clinical Research Organizations, and study site investigators/personnel. They adhere to environmental policy, procedures, and support department environmental objectives. They engage in Credo-based decision-making where our responsibility is to our patients and doctors. **You will:** + Own processes and information required to complete and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work + Accountable for the preparation and finalization of key clinical documents which include the informed consent, case report forms, and other essential study documents + Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required for testing investigational and/or marketed devices + Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable + Contribute to the improvement of clinical trial processes, including benchmarking and maximizing across other J&J companies + Other related duties as assigned by management **Qualifications:** + Bachelor of Science or equivalent degree + 5+ years' experience in Clinical Research in a medical device or pharmaceutical regulated industry + Must have a minimum of 2 years' experience as a clinical research associate + Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) + Strong communication, organizational and interpersonal skills + Basic understanding of diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.) + Ability to effectively work with a team and influence peers, affiliates and Regulatory agencies (primarily IRBs/Ethics Committees) to ensure that regulatory and business needs are met + Travel: Up to 20% \#LI-AM2 _Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._ _Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource._ **Required Skills:** **Preferred Skills:** Clinical Studies, Clinical Trials, CRA Training

Good Samaritan University Hospital is a 537- bed (including 100 nursing home beds) teaching hospital and a member of Catholic Health. With almost 900 physicians on staff, and a level I Trauma Center, we care for well over 100,000 patients annually across the south shore of Long Island. Our reputation for excellence is built on great choices and empowered leadership, and fosters a team that's focused on evidence based practice, continual learning and exceptional quality of care. Are you exceedingly driven, dedicated, and passionate about caring for your patients? Do you consistently create and nurture meaningful relationships with your team, your patients, and their loved ones. Can you strike the perfect balance of integrity, compassion, accountability, respect, and excellence? Then you have what it takes to be a Good Samaritan Nurse. You are at the heart of health. Job Details Research Nurse Specialist- Cancer Services Job Duties: * Coordinates the day-to-day management of clinical trial, ensuring that the study is conducted in accordance with relevant legislation, research protocols and guidelines * Screens patients to determine if appropriate for enrollment in clinical trial, maintain screening logs, complete inclusion-exclusion eligibility, obtain and document participant consent * Provides education and information to study participants and families about clinical research participation and compliance. Discusses study issues with the study investigators, serving as a liaison/advocate between the participant/family and the physician * Coordinates patient study enrollment, collect source documentation from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Enters data into relevant EDC in a timely manner * Identifies actual or potential patient/family problems and involves all needed disciplines in the planning and implementation of actions to address these concerns * Administers care to patients, as needed, to maintain clinical and research skills, to assess patient care requirements or to provide support to patient care staff * Collects and submits data to sponsors and database as required; ensures that clinical research data is accurate, legible, timely and in compliance with the requirements of the study * Reconciles data queries in a timely manner by communicating with sponsors and submitting the requested information * Communicates the protocol schedule for each patient, including but not limited to the following: tests, procedures, diagnostics, and consultations to both the patient and the relevant clinical team. Adheres to and complies with protocol specific requirements * Assists PI with the identification and reporting of deviations, serious adverse event, or unanticipated problems * Collaborates and identifies Serious Adverse Events (SAE), Adverse Events (AE), and Unanticipated Problems (UP) and facilitates the grading and attribution with the Study Investigator and reports both internally and externally according to study specific guidelines * Identifies potential or actual deviations from study requirements and standards of practice * Attends and participates in protocol site initiation visits and any other applicable sponsor meetings or calls * Meets with medical investigators on a regular basis to review clinic for potential patients, maintain MD screening and new visit logs * Utilizes organization's electronic health record and departmental calendars to screen patients and coordinate necessary assessments. Develop and maintain patient study tracker to ensure patient protocol compliance * Ensures that the required information is complete, accurate, and readily available for clinical research audits or study sponsor monitor visits, i.e.: medical records, case report forms and other source documents. * Must be available during monitor site visits or audits to answer questions and resolve identified issues and concerns * Participates in EPIC beacon build configuration for oncology treatment plans * Provides research study education to ambulatory and inpatient nursing, and others involved in the care of the research patient * Coordinates the collection and handling of specimens required by clinical research studies and collaborates with the Laboratory Team to ensure the specimens are processed in accordance with study requirements * Participates in the orientation of new personnel ensuring an environment which promotes learning and mentoring by experienced staff members * Provides cross coverage to other clinical research nurse and/or coordinators as needed * Develops interdepartmental relationships with internal and external stakeholders including pharmacy, laboratory, pathology, trial sponsor, sponsor medical science liaisons, regulatory agencies, CRO, outside data collection agencies and others * Maintains established departmental policies and procedures, objectives, quality assurance programs, safety and compliance standards * Enhances professional growth and development by participating in educational programs, reading current literature, and participating in in-service meetings and workshops * Participates and pre-screen patients for multi-disciplinary tumor boards. Collect data to present on Cancer Committee Meetings * Communicates on a regular basis with Research Oncology Manager * Practices regular hand hygiene and complies with standard and transmission based precautions as applicable * Responds appropriately to the special needs of each group served specific to age, language, gender, culture, religion/spirituality, economic background, education or literacy, developmental or cognitive disabilities, physical and developmental disabilities NOTE: The duties described in this job classification standard are intended only as illustrations of the various types of work that may be performed by employees in this title. The omission of specific duty descriptions does not exclude them from the job if the work is similar, related or a logical assignment for the title. This job classification standard does not constitute an employment agreement between the individuals employed in this title and Good Samaritan University Hospital and is subject to change by the employer as the needs of the employer and requirements of the job change. Education: * BSN required, Advanced degrees encouraged (MS, MPH, NP, MPA) Licensure/Certification: * Current NYS Registered Nurse License * Clinical Research Accreditation preferred (ACRP, SOCRA, GCP, IATA, NCI) * Basic Life Support (BLS) (AHA) * Current certification as an Oncology Certified Nurse (OCN) or other applicable certification Salary Range USD $54.48 - USD $72.17 /Hr. This range serves as a good faith estimate and actual pay will encompass a number of factors, including a candidate's qualifications, skills, competencies and experience. The salary range or rate listed does not include any bonuses/incentive, differential pay or other forms of compensation that may be applicable to this job and it does not include the value of benefits. At Catholic Health, we believe in a people-first approach. In addition to the estimated base pay provided, Catholic Health offers generous benefits packages, generous tuition assistance, a defined benefit pension plan, and a culture that supports professional and educational growth.

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_

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram. Position Summary: We have an exciting opportunity to join our team as a Research Coordinator - Cardiac Cath Lab. Responsible for providing moderate to advanced range of coordination of Research studies conducted within the Division of Cardiology's Cardiac Cath Lab. Coordinator will assist with the recruitment, enrollment, grant submissions, research data collection and study coordination activities. Performs intra-operative monitoring and serves as liaison with internal and external funding agencies. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and required obligations to patient/subject, Principal Investigator, Research Team and sponsor. Interfaces directly with patients/subjects and Principal Investigator in support of the clinical trials if applicable. Establishes liaisons with relevant parties at the Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems and regulatory Services. Might assist in the initiation and management of research studies. Works under general direction Job Responsibilities: * Grants -Prepares and submit grant applications and other grants related an activity such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if applicable. Follow up and coordinates resolution of all issues progress. Reports to the sponsors to fund medical research in the division. * Human Subjects' Research - As applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research (e.g., ensures the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrollment statistics to the Office of Clinical Trials, and provides other information in timely manner, as necessary. * Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects reminding them of visits and compliance. May monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. * Data Management - Responsible for collecting and auditing patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc); abstraction of data for publications, or data collection from outside physicians offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports. Conducts study visits, obtains and documents information within the time frame specified. * Budget - Develops a preliminary draft budget and submit to the Director/Principal Investigator. Reviews sponsor-proposed budget for adequate coverage and recommend changes as appropriate. Assists in the preparation of funding reports to funding agencies and helps identify new potential sponsors/agents for trials and researches. Monitor budget throughout trial. * Decision Making and Problems Solving Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations and refers non solved issues and questions with recommendation to supervisor. * Participates in special projects and performs other duties as required. * Recruitment - Screens potential patients/subjects for eligibility to the study. This may include gathering information from the medical record, physician referral, advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study. * Clinical Competency - competency in performing EKG, phlebotomy technique, centrifuge, handling, storing and shipping of specimens. Clinical training and didactic competency tests may be required to perform basic procedures as part of position expectations. In house training and certification will be provided. Other trainings and competencies may be included as required. * Continuous Learning - Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in research role and maintains current expertise in area of practice. Maintains annual requirement of 10 CEUs in continuing research education; employee must demonstrate proof of ongoing research education. Serves as a resource to peers and works collaboratively with other disciplines within the area of expertise. * Reporting and Analysis- Researches, compiles and consolidates data and conducts preliminary analyzes to data collected for presentation to sponsoring and regulatory agencies. Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Formulates, prepares database and generates preliminary measurement reports for review by PI. May complete assessments on study subjects/patients following protocol (with proper training); continues to follow-through with items and patients as part of the research study. Minimum Qualifications: To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related field. Minimum of two years of progressively responsible project coordination experience, preferably in a research setting. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Commitment to continuous learning as required by department administration. Ability to operate research related equipment Ability to work and make decisions independently. Time management skills and ability to multitask. Ability to identify, analyze and solve problems: Ability to work well under pressure. Preferred Qualifications: Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical terminology is preferred. Experience working in an Academic Medical Center preferred Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family. NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online. View Know Your Rights: Workplace discrimination is illegal. NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $64,350.00 - $64,350.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. To view the Pay Transparency Notice, please click here

Our Company Amerita The Specialty Clinical Review Coordinator will ensure referrals and new orders meet clinical admission payer criteria. This role ensure that all assigned specialty patients are provided with timely and exceptional clinical service and an exception customer experience. Schedule:Monday - Friday 8:30am - 5:30pm * Competitive Pay * Health, Dental, Vision & Life Insurance * Company-Paid Short & Long-Term Disability • Flexible Schedules & Paid Time Off• Tuition Reimbursement • Employee Discount Program & DailyPay• 401k * Pet Insurance Responsibilities * On-board all new specialty infusion referrals * Manage relationships with internal customers to ensure effective workflow * Reviews referral documents and updates information in the patient's demographics * Reference clinical admission criteria for specialty therapies and navigate patient charts to locate documentation for admission criteria * Works closely with sales partners to ensure completeness of submitted referral information * Participates in the development of best practices for documentation supporting clinical care and reimbursement qualification for Specialty Patients * Support patient retention efforts by ensuring all reasonable interventions are executed to retain a patient on service * Supervisory Responsibility: No Qualifications EDUCATION/EXPERIENCE• Pharmacy Technician background • Recent three to five (3-5) years of experience in specialty pharmacy, home infusion and/or home health• Experience in Microsoft BI. Experience in Outlook, Word, and PowerPoint desired LICENSE/CERTIFICATION/OTHER SPECIAL REQUIREMENTS• State pharmacy technician licensure• PTCB certified technician credentials preferred KNOWLEDGE/SKILLS/ABILITIES• Ability to work effectively within a multidisciplinary team TRAVEL REQUIREMENTSPercentage of Travel: 0-25% To perform this role will require sitting, and typing on a keyboard with fingers for an extensive amount of time, and occasionally standing, walking, bending, and reaching. The physical requirements will be the ability to push/pull and lift/carry 1-10 lbs About our Line of Business Amerita, an affiliate of BrightSpring Health Services, is a specialty infusion company focused on providing complex pharmaceutical products and clinical services to patients outside of the hospital. Committed to excellent service, our vision is to combine the administrative efficiencies of a large organization with the flexibility, responsiveness, and entrepreneurial spirit of a local provider. For more information, please visit ****************** Follow us on Facebook, LinkedIn, and X. Salary Range USD $24.00 - $28.00 / Hour

Job DescriptionSalary: The Experienced Clinical Research Coordinator (CRC) will support the Clinical team in their efforts to achieve daily and overall company goals. Work as an integral member of Hillcrest Medical Research Site staff, maintaining the day-to-day relationship with patients and assisting in developing the HMR network. This includes planning, coordinating, and, as appropriate, the execution of clinical studies according to the protocol, contracted scope of work, sponsor, CRO, and HMR SOPs and any relevant guidelines regulations. Essential Functions & Responsibilities: Duties include but not limited to: Work directly at the patient\subject interface at the research site to deliver high-quality patient data according to local regulations, agreed scope of work, and as required by the protocol. Attend and participate in an investigator meeting, monitoring visits, audits, seminars, and other regions on national meetings. Assist with pre-screening, screening, and enrollment of subjects into assigned studies. Support subjects on trial to ensure a positive patient experience. Assist with the establishment of a recruitment and contingency plan for each study Perform function necessary for successful completion of all protocol required visits\procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of the investigational product, scheduling, drug accountability\reconciliation, and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements. Accurately complete source documents and case report forms in both paper and electronic format. Assist investigators with recording and reporting of adverse events and SAE as per local regulatory authority guidelines. Assist in the clinical, operational efforts of the team between HMR clinical research sites. Perform all training modules required by HMR SOP in a timely and effective matter. Source document completion and Data Entry Study and visit Preparedness & Monitor visit preparation Patient scheduling assistance and recruitment, as needed Accept direction and constructive criticism from supervisors and managers in compliance with Hillcrest Medical Research policies and procedures. Skills & Abilities: Sound knowledge of medical terminology Sound knowledge of IHC\GCP and regulatory requirements Ability to work independently and as part of a team while under pressure without supervision Excellent interpersonal and organizational skills Ability to organize and prioritize work and responsibilities Strong interpersonal skills creating and maintaining a positive dialogue with sponsors/CROs, clients, and colleagues Ability to maintain confidentiality Excellent attention to detail Strong quantitative, research, and data analytic skills Proficiency in Microsoft Office Suite Education & Experience: MA, LPN, RN, CNA, EMT, Paramedic or equivalent or higher preferred. Phlebotomy Certification preferred. At least 2 Years of experience as a Clinical Research Coordinator Hillcrest Medical Research is an equal opportunity employer. Decisions of employment are made based on business needs, job requirements and applicants qualifications without regard to race, color, religion, gender, national origin, disability status, protected veteran status, genetic information and testing, family and medical leave, sexual orientation, gender identity or expression or any other status protected by law. Hillcrest Medical Research is a drug-free work place and all offers of employment are contingent upon passing a pre-employment drug screen.