Clinical coordinator jobs in Greenburgh, NY - 332 jobs

Regional Cancer Care Associates (RCCA) is looking for an exceptional Clinical Research Manager to join the team. This position manages clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures(SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include Code of Ethics and Business Standards. This individual must also possess strong multi-tasking abilities and bring positivity and passion to their work. If you want to join a team that is on the cutting edge of cancer care, while always putting the patient first, we want to hear from you! Employment Type: Full Time Location: Belleville, NJ As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. Key Responsibilities: Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice. Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, and progressive discipline. Enforces adherence to company policies. Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Develops accountability standard to ensure that targets and budgets are achieved. Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program. Responsible to promote or market research program to the practice, community and referring physicians. Responsible for coordinating research activities with other (non-USOR) bases or sponsors. Requirements Minimum Job Qualifications (Knowledge, Skills, & Abilities): Education/Training: Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred. Business Experience: Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred If required for state of practice, current licensure as a registered nurse (RN) SoCRA or ARCP certification preferred Specialized Knowledge/Skills: Excellent communication skills, strong ability to multitask Strong interpersonal skills Must be able to work in a fast paced constantly changing environment Knowledge and proficiency in all basic computer programs, windows, excel etc. Special knowledge of GCP and ICH guidelines Specific knowledge of all aspects of clinical research - ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle Working Conditions: Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)

Responsible for the coordination and intake process for all incoming clients at Article 29i and Article 31(MHOTRS) Clinic. Must have exceptional customer service, ensuring that clients receive a positive intake experience. Will also coordinate, participate, and provide expert/professional clinical guidance in treatment team meetings concerning mental health issues and behavior management. GENERAL RESPONSIBILITIES Conduct Intake Evaluations, including initial psychosocial assessments and related documentation, for adults and/or children. Initiate contact with patients and relevant external sources to gather necessary clinical and demographic information. Provide ongoing support and guidance to clients throughout the intake process, ensuring a smooth transition into services. Schedule, track, and participate in family and interdisciplinary team meetings to provide mental health and educational updates. Coordinate with case planners, caregivers, and service providers, actively participating in Quarterly Treatment Plan Reviews and completing related documentation. Maintain accurate and up-to-date clinical records and progress notes in compliance with program, ACS, OCFS and OMH mandates. Complete referral packets and collaborate with the Assistant Director (AD) to determine case assignments. Assist with administrative tasks, including verifying and processing co-pays (if applicable), scheduling and following up with clients, and providing front desk coverage as needed. Perform other duties as assigned. PHYSICAL REQUIREMENTS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. An employee in this position is regularly required to stand; walk, use hands and fingers, handle, or feel objects; reach with hands and arms; talk and listen, and taste or smell. The employee frequently is required to walk. The employee is occasionally required to keep balance and stoop, kneel, crouch, or crawl. Computer - The Clinical Intake Coordinator must be able to use a computer and able to learn software programs Office Equipment- The Clinical Intake Coordinator is required to operate a fax, copier, scan, and other office equipment. Communication - The Clinical Intake Coordinator needs to be able to speak, read and write fluently in the English language Writing - The Clinical Intake Coordinator must be able to write in the English language using correct spelling, grammar, punctuation, etc. Lifting - The Clinical Intake Coordinator may frequently lift 0-25 lbs., occasionally lift 25-50 lbs., and rarely lift over 50 lbs. Push/Pull - The Clinical Intake Coordinator may frequently push/pull 0-25 lbs. of force, occasionally push/pull 26-45 lbs. force, and rarely push/pull over 45 lbs. Sitting, Standing and Walking - The Clinical Intake Coordinator will be required to sit, stand and walk throughout the work day. Stooping -The Clinical Intake Coordinator may occasionally stoop. This is defined as bending body downward by bending spine at the waist. Kneeling -The Clinical Intake Coordinator may occasionally kneel. This is defined as bending legs at knees to come to rest on knee(s). Crouching - The Clinical Intake Coordinator may occasionally crouch. This is defined as bending body downward and forward by bending spine and legs. Work environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee frequently works in an office environment. The noise level in the work environment is usually moderate due to talk and movement of the program participants and other co- workers. The noise level can increase on occasion due to yelling or screaming by the participants of the programs. Qualifications QUALIFICATIONS MSW required, LMSW preferred (LMSW Clinical Hours Offered) Minimum of 5 years of clinical experience in child welfare, with a strong understanding of child welfare and child protective services. Proficiency in diagnosis and familiarity with Evidence-Based Models. Experience working with Electronic Health Records (EHR) and general IT systems. Strong clinical, communication, and presentation skills, with the ability to facilitate meetings. Valid NYS Mental Health Provider License required. Bilingual (Spanish & English)-proficient in both written and oral communication. Passion for working with children and families from diverse cultural backgrounds. Ability to thrive in a fast-paced environment, demonstrating excellent time management and multitasking skills. HOURS AND TIME OF WORK Monday to Friday - 35 Hours

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Clinical Specialist, Cardiothoracic (CT) position provides strategic account management, expertise, and support with respect to Getinge Cardiac Assist products in an identified geographical area. The position provides customer training and education on responsible product portfolio including supporting product evaluations. The position supports and collaborates with the implementation team to ensure successful client outcomes. The position also indirectly sells and promotes Getinge Cardiac Surgery products within the defined geographic territory, by focusing on key accounts and expanding the usage of Cardiac Surgery products through clinical evaluations, presentations, and customer support. This territory will support the Northeast Region. Job Responsibilities and Essential Duties * Serve as a key business partner to clients in the field, by developing and maintaining strong customer relationships. * Develop and understand Business Plans for assigned geographic territory. * Develop relationships with hospital personnel (e.g., through casual conversation, meetings, participation in conferences) to make new contacts in other departments within the hospital. * Proactively understand customer needs and when complaints arise regarding products, develops creative and feasible solutions or working with other related personnel (e.g., clinical research, marketing) to develop optimal solutions. * Support the needs of the client, including but not limited to product demonstrations, in-services, case support, product complaints etc. In addition, identifying types of cases handled by specific customers by meeting with and asking in-depth questions of physicians and other hospital personnel to learn which Getinge products can best address their specific needs. * Observe actual procedures within varying departments of hospital accounts to gain insight into the specific nuances of each physician and each member of the clinical staff. Support in-services and staff training on assigned products. * Ongoing discussion and reviews with local reps to provide input on the needs, issues, and suggestions in the development of their business plans, to help the organization achieve its annual Cardiac Surgery sales goals. * Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals). * Establish and maintain a business climate that fosters positive and cooperative working relationships with customers, and all Getinge personnel, resolve problems that may develop to the mutual benefit of the customer and Getinge. * Comply with all health and safety codes and procedures as mandated by Getinge policies, customer requirements and regulatory agencies. * Support existing products utilized by customers and support new Cardiac Surgery installations as needed during regular visits with current customers and/or potential Cardiac Surgery customers to fulfill revenue and unit growth objectives assigned by company on a monthly/quarterly/annual basis. * Perform other related duties as required or assigned. Minimum Requirements * Bachelor's Degree or an equivalent combination of education and experience. * Minimum combined 5 year's applicable clinical experience in a Hospital environment and/or sales support including product education and training required. * Must have a valid driver's license. #LI-JW1 Required Knowledge, Skills and Abilities * Demonstrated record of success or achievement in clinical positions. * Solid understanding of specified functional area, and application of business concepts, procedures, and practices. * Capable of managing time and resources within the assigned territory in conjunction with near-term plans to ensure the territory's objectives are achieved. * Must perform this job in a quality system environment, ensuring compliance with governmental regulations and maintaining honesty, integrity, and excellent work ethics. * Be able to enhance teamwork within the region and maintain a collaborative relationship with all levels of the organization. * Good communication skills, organization and computer skills required. * Carry out operations within an established budget. * Must have sound knowledge of a variety of alternatives and their impact on the business and be able to exercise judgment in selecting innovative and practical methods to achieve problem resolution in the assigned territory. * Establish and cultivate an extensive network of support to facilitate completion of assignments. * Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel. * Basic to intermediate skills in Microsoft Excel, Word and Outlook and familiarity with CRM tools. * Use of computer and telephone equipment and other related office accessories/devices to complete assignments. * May work extended hours during peak business cycles. * The position requires travel of approximately 50% or more. * Must be able to lift up to 50 lbs. Sales salary range: Total Compensation= $160,000 - $165,200 (base + at plan target incentive) depending on experience and location About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: * Health, Dental, and Vision insurance benefits * 401k plan with company match * Paid Time Off * Wellness initiative & Health Assistance Resources * Life Insurance * Short and Long Term Disability Benefits * Health and Dependent Care Flexible Spending Accounts * Commuter Benefits * Parental and Caregiver Leave * Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

The Long Island University College of Veterinary Medicine (LIU-CVM) invites applications for the position of Clinical Affairs Coordinator (CAC). The CAC will report to Director of Clinical Programs. The CAC will work with the Vice Dean of Clinical Programs, Assistant Dean of Clinical Programs, Director of Clinical Programs, administrative assistant(s), Clinical Year Lead Veterinarian's, and Clinical Faculty in facilitating the oversight, planning, and scheduling of all off-campus workplace-based educational experiences experiential learning experiences and other duties as assigned. The CAC will review and enforce the veterinary practice policies and protocols as they apply to students visiting and rotating through those off-campus facilities. Collaborating with off-campus sites the CAC will ensure that all off-campus facilities provide a safe learning environment and adhere to safety and biosecurity policies and procedures as described in the College's Standard Operating Procedure (SOP). Job Responsibilities * Ensure the policies and procedures established by LIU-CVM are fully implemented in the off-campus sites through collaboration with Clinical liaisons and the Clinical Programs team * Works collaboratively with the Clinical Programs team and clinical sites to implement safety and biosecurity measures required by the Clinical Programs team and the Clinical Affairs Committee. * Monitor, organize, and maintain necessary information/documents for sites to maintain affiliate status as well as various student and faculty files/documents * Assist with communication of relevant information to clinical year students and off campus sites * Assist with the management of the department budget and payment of off-campus affiliate sites * Assist with student registration * Monitor, organize, and maintain student and faculty files/documents * Assist in Scheduling student learning experiences of clinical clerkships in year 4 * Interact effectively with a diverse student, faculty, staff, clinical affiliate population and resolve problems * Communicate policies, procedures and practices to faculty, students, university personnel and clinical affiliates * Maintain databases to gather data, compile statistics and generate reports * Oversee and manage additional support staff * Serves as ex-officio member in the LIU-CVM Clinical Affairs Committee * Other duties as assigned Job Skills & Qualifications * Work experience and familiarity with the veterinary medical profession * Strong people skills including communication and emotional intelligence * Solutions-oriented and problem solving * Discretion and professionalism in management of sensitive personal and college materials * CVT/LVT/RVT or MSc credentials will strengthen the position application, but are not essential * Proficiency in the use of excel, word, OneDrive, and various software programs (i.e. Evalue) Knowledgeable of: * AAHA Standards * Occupational Safety and Health Administration (OSHA) Regulations * NY Veterinary Medical Board, Veterinary Medicine, Veterinary Technology * Practice Guidelines from the Office of the Professions, New York State Education Department About The College of Veterinary Medicine at Long Island University: LIU-CVM received a Letter of Reasonable Assurance from the AVMA- Council on Education on October 16, 2019 and graduated its inaugural class in May 2024. Currently, with over fifty off-campus affiliate sites, LIU Lewyt College of Veterinary Medicine utilizes a distributed model of clinical education. The Lewyt College of Veterinary Medicine has modern physical facilities designed to support its instructional needs and research activities. ****************** LIU is an equal opportunity employer. LIU is committed to extending equal opportunity in employment to all qualified candidates who can contribute to the diversity and excellence of our academic community. LIU encourages applications from all qualified individuals without regard to race, color, religion, genetic information, sexual orientation, gender and/or gender identity or expression, marital or parental status, national origin, ethnicity, citizenship status, veteran or military status, age, disability or any other basis protected by applicable local, state or federal laws. Hiring is contingent on eligibility to work in the United States.

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include- applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in. Job Title: Clinical Trials Disclosure Associate Duration: 1 year+ Location : Woodcliff Lake, NJ JOB DESCRIPTION: The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives. Person will be responsible for coordinating the posting of registration and disclosures on clinicaltrials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinicaltrials.gov and EudraCT disclosure). Must be database proficient with registrations and disclosures. Has the ability to work cross-functionally and meet required deadlines. Ensures trial disclosure is in compliance with applicable regulations globally. Develops and maintains strong internal relationships across all levels of the clinical organization. Escalates issues to management in an expedient manner. Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures. On occasion, responsibilities may be extended to:- reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion Coordinates all Client clinical disclosure activities, acting as primary intermediary between the disclosure vendor and Client contacts 30Works with Client contacts to identify and resolve compliance gaps 30 Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel 20 Maintains Client disclosure trackers and produces metrics reports for management 10Maintains Client product information for use in disclosure activities 10. REQUIREMENTS: Bachelor's degree required. Atleast 3 years working in the pharmaceutical industry in an R&D environment. Solid knowledge of clinical trial transparency principles, preferably on an international level Strong attention to detail and the ability to work as a part of a team across multiple departments Strong communication and influencing skills. Additional Information Regards, Pooja Mishra, 732-243-0715

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions - and a better life for those living with diabetes - with the world's first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user's weight - the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management. *User must be carb aware. Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact. Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team! Beta Bionics is seeking a passionate and driven Clinical Diabetes Specialist to join our fast-growing startup. We're revolutionizing diabetes care with the iLet, the world's first closed-loop insulin delivery system with fully autonomous insulin dosing and no requirement to count carbs. In just our first 18 months on the market, we've experienced unprecedented growth-outpacing any other diabetes product launch! Our future looks even more exciting with the development of a patch pump and a bi-hormonal system utilizing insulin and glucagon. This is your chance to get in on the ground floor of an exciting, mission-driven start-up company. If you're a CDCES, interested in working in the industry or have already made a career in the industry, and passionate about healthcare innovation, we'd love to have you on our team. Join us and help shape the future of diabetes care! Summary/Objective: As the Clinical Diabetes Specialist, you are responsible for the promotion and clinical support of Beta Bionics products and services within your assigned geography. You are responsible for managing the training journey for people with diabetes. You will be the main point of contact for the educational needs of the iLet user, healthcare professionals and staff. In partnership with the Territory Business Manager and Inside Sales Specialists, you will develop a targeting and business strategy and develop and maintain strong relationships with our customers. This role requires that you work well in a collaborative environment with the ability to influence cross-functional team success. You must have strong planning and organizational skills with the ability to handle multiple priorities. You will operate with a passion to serve people living with diabetes and our communities. Essential Duties and Responsibilities [Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact] Responsible for driving territory goals through strong clinical experience in diabetes Manages, conducts, and supports the training journey for people with diabetes Demonstrates strong teaching and training ability for providers and people with diabetes Will use strong selling skills through a clinical medium Works in conjunction with Territory Business Manager and Inside Sales Specialist to achieve territory goals Maintains compliant communication/documentation with team through Salesforce.com Assists with providing product demos to providers, people with diabetes and families Demonstrates excellent communication and presentation skills Responsible for training the trainer in provider offices Demonstrates empathy with a passion to serve people with diabetes Stands out as a Health Coach - sees the person with diabetes holistically Demonstrates effective planning and organization skills with ability to handle multiple priorities Ability to navigate and influence at all levels within an HCP and IDN environment Required Education and Experience RN or RD CDCES required Acceptable licenses: APRN, NP, PA Minimum requirement of 3 years diabetes experience Preferred Experience and Qualifications 5+ years diabetes experience Preferred industry experience Work Environment and Personal Protective Equipment This is a field-based position. Candidate must reside in the geography specified in the job title Physical Demands While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers This position requires travel depending upon business needs Compensation and Benefits The annual base salary for this position is $90,000 - $100,000, plus an annual commission target, resulting in an annual earnings target of $128,000 - $138,000. Beta Bionics offers a competitive compensation package that includes equity and comprehensive benefit offerings. Beta Bionics offers healthcare benefits for employees and their families including medical, dental, and vision coverage, as well as flexible spending accounts (FSA) and a health savings account (HSA) that includes an annual company contribution. Our comprehensive benefits package also includes a 401k with a generous company match and no waiting period plus immediate vesting, an open PTO policy, and 10 paid holidays per year. Annual base salary will vary based on skills and experience, and may vary depending upon a candidate's location and relevant market data. Equal Employment Opportunity Statement It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Provide operational leadership for assigned trials executing them on time and within budget • Overall coordination and management of clinical trials from startup to closeout • Liaise with other functional areas to identify issues, evaluate and make sound business decisions and ensure implementation of timely solutions. • Identify and select high-quality clinical vendors in conjunction with the appropriate team members • Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined. • Manage and effectively provide oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements. • Assure that team is receiving high quality, on time deliverables from internal and external vendors. • Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports. • Work with finance manager on financial aspects of the project(s), including milestone payments, and monthly pass through invoices • Lead or facilitate teleconferences with internal or external group. • Oversee Clinical Trial Coordinator for assigned project to ensure successful management of project(s), including development of the project plan, maintenance of trackers, and generation of metrics reports • Assume co-monitoring responsibilities as needed. • Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues • Manage the publication process in conjunction with the publications team to assure that submission timelines are met. • Monitor and report clinical trial status using standard and adhoc review & reporting procedures and identify issues that affect functions. • Ensure that each function is accountable for their deliverables. • In collaboration with Project Management and utilizing various tracking mechanisms, manage clinical trial project milestones and budget. • Proactively identify issues and escalate to appropriate managers. Qualifications • At least 10 years of experience in the management of clinical trials, significant knowledge of overall clinical drug development and general clinical research operations in Big Pharma. • Ability to manage multiple projects simultaneously with strong organizational and planning skills. • Well-developed analytical and problem solving skills. Communicates issues to Director with action plans for resolution. • Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP. • Ability to effectively work with teams and promote collaborations. Exceptional interpersonal skills including the ability to influence negotiate and resolve conflicts. • Excellent verbal and written communication skills and the ability to interact with all levels of management within the organization and to external business contacts. Experience using the Inform database, PowerPoint and Excel software. • Independent judgment and decision making skills with respect to functional responsibilities. Innovative and motivated in optimizing clinical operations processes to meet deliverables. • Minimum BS or BA in related field; focusing on biological science or nursing preferred or equivalent. Advanced Degree preferred Additional Information For more information, Please contact: Sneha Shrivastava ************

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Job Description .S. degree. • Minimum of 3 to 5 years of pharmaceuticals/biotech experience. • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. • Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model, ideally in pharmaceuticals/biotech. • Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections. • Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics. • Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. • Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial. • Demonstrated experience in change management initiatives preferred. • Program and project management experience preferred. • International experience a plus. Qualifications Responsible for supporting the Senior Clinical Trial Manager/operational study lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget). Additional Information All your information will be kept confidential according to EEO guidelines.

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality, operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions. This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience. What You'll Do Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals. Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies. Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle. Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution. Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions. Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost. Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research). Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner. Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel. Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics. Qualifications Bachelor's degree with 8 years, a Master's degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required. In-depth knowledge of ICH-GCP, regulations, directives, and guidelines. Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems. Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety. Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams. Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery. High sense of accountability and urgency to prioritize deliverables effectively. Growth mindset and ability to independently. PMP certification preferred. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. Essential Duties and Responsibilities: Assist to plan, implement, manage and report for regional or global clinical studies. Manage selection process of CROs for regional or global clinical studies. Manage the performance of study vendors (e.g. CROs and central labs) Manage activities for clinical site selection, investigator meetings and study initiation. Oversight of patient recruitment and development of recruitment strategies and plans Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.) Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans. Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols. Coordinate negotiation of clinical trial contracts between investigational sites and CROs. Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan. Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites. Implement project specific training program and training materials Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes. Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.). As needed and required perform other tasks and functions. Qualifications: Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise. Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors. Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies. Ability to handle multiple tasks and prioritize. Strong organizational, communication and presentation skills. Team player, flexible, ability to adapt to change. Must be able to travel within the US and outside of US 15-25% monthly and interact with Investigators in-person regarding the protocol and study drug. Education and Experience: Bachelor's Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience. Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. Program and project management experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs Discretionary Bonus Programs and Long-term Incentive Plan Retirement Savings 401k with company match Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown. Career Development, Progression and Training Flexible Work Arrangement Programs Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Clinical Trial Manager needs Bachelor's degree and minimum 3 years experience in the healthcare or clinical trial industry, or the equivalent combination of education and experience. Clinical Trial Manager requires: Extensive knowledge of clinical development principles, theories and concepts and high degree of comprehension of pharmaceutical industry practices, standards and GCP's. Thorough working knowledge of the clinical trial lifecycle from protocol development and feasibility through study closeout and reporting. Ability to manage complex, multiple studies simultaneously. Some may be of a global nature Clinical Trial Manager duties: Manages/oversees the conduct and execution of assigned clinical trails and associated activities in accordance with Good Clinical Practices (GCP) and relevant standards. Assists with the review and determination of appropriate site and vendor selection and ensures all vendors meet predetermined program milestones. Additional Information $54/hr 12 months

About Sequel Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel's approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel's flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management. Job Overview As a Clinical Diabetes Specialist (CDS) you will partner with a Territory Business Leader (TBL) to successfully launch a new innovative insulin pump and future Sequel products. Your primary responsibility is to deliver unparalleled clinical education and product training for people with diabetes and healthcare providers to drive product adoption and support persistent use. In partnership with the TBL, you will formulate territory strategies and initiatives to meet/exceed territory goals. As a Senior Clinical Diabetes Specialist, you will additionally take on a leadership role within the team by mentoring junior staff, assisting with field sales training, and participating on internal advisory boards. Territory includes Northern New Jersey (Paramus, Hackensack, Newark, Patterson), Rockland County, NY and Lower Westchester (Yonkers, New Rochelle).Job Responsibilities and Essential Duties Develop effective territory planning and strategies with TBL to meet/exceed territory goals. Execute clinical selling strategies within assigned accounts. Assess referrals for product use in people with diabetes to confirm criteria are met for product utilization. Facilitate product education and training for users of Sequel products. Drive healthcare provider adoption and confidence in Sequel products by promoting the clinical benefits of automated insulin delivery with Sequel products and conducting impactful product demonstrations. Certify healthcare providers to conduct product training for people with diabetes. Facilitate virtual product training and other educational webinars. Communicate user feedback cross-functionally to solve problems and improve product development. Collaborate with customer care and sales support to optimize the user experience. Consistently exhibit a high level of proficiency and expertise in discussing and demonstrating Sequel products, as well as expertise in diabetes and therapeutic options for diabetes care. Participate in conventions, educational forums, and meetings to increase product awareness. Manage all leads and opportunities in customer relations database daily and submit product training documentation as required. Maintain a high profile with state and local patient advocacy groups and professional diabetes organizations, such as local chapters of ADA (American Diabetes Association), ADCES (Association of Diabetes Care and Education Specialists), and Breakthrough T1D (formerly known as Juvenile Diabetes Research Foundation). The Senior Clinical Diabetes Specialist will have the following additional responsibilities: Assist with field sales and clinical training. Participate in advisory boards with cross-functional departments. Mentor junior staff. As needed, lead weekly team calls, regional and/or area calls and/or meetings. Minimum Requirements A valid professional license in one or more of the following fields: RN, RD, PA, NP, Pharmacist. Certified Diabetes Care and Education Specialist (CDCES) is preferred. 2+ years of experience coordinating and conducting diabetes education with strong experience in the technical use of diabetes technology preferred. For the Senior CDS role: Certified Diabetes Care and Education Specialist (CDCES) certification required. 4+ years of clinical diabetes education experience. Experience coordinating and conducting diabetes device education in the medical device industry preferred. Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. At Sequel, we believe that when you thrive, we thrive. That's why our benefits package is designed to support you from day one. You'll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting. We're committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans. You'll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA). Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care. In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind. We know the importance of taking time to rest and recharge. That's why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most. Our team enjoys a culture built on hard work, fun, and genuine support. At Sequel, you're not just starting a job, you're building a rewarding career and a brighter future. Join us, and let's thrive together! Environmental/Safety/Physical Work Conditions Ensures environmental consciousness and safe practices are exhibited in decisions Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles Physical requirements such as lifting specific weights Some travelling is expected

Sr. Clinical Research Associate NY/NJ ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. **What You Will Be Doing:** + Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. + Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. + Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. + Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. + Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations. **Your Profile:** + Advanced degree in a relevant field such as life sciences, nursing, or medicine. + Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. + Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. + Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. + Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. + Must be located in the Midwest (areas like Chicago or Detroit/Ann Arbor, MI are ideal) + Oncology monitoring experience required + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols. Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team. Ensure compliance with the Good Clinical Practice guidelines in clinical research. Monitor study patients for adverse events in collaboration with clinical team and report as required. Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements. Qualifications Education requirement: BS Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments. Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This field-based position is based in either New York or New Jersey. Purpose and Scope: A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Responsibilities & Accountabilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

Clinical Research Site Manager The Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. Also To ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites. Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s). Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents. Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations Coaching, counseling, and disciplining the employees as applicable. To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards. Communicating and effective implementation of strategic goals from senior management to the site team. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: Bachelor's degree preferred Advanced degree preferred Experience: At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization. Credentials: Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred. Knowledge and Skills: Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail. Critical Thinking Active Listening Reading Comprehension - Understanding written sentences and paragraphs in work-related documents. Speaking and Writing to communicate effectively as appropriate for the needs of the audience. Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams. Strong computer skills in relevant software and related clinical systems are required. Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.

Clinical Research Associate Duration : 12 +months contract Start Time : 08:00 AM End Time : 05.00 PM Total Hours/week : 40.00 Qualifications: The Clinical Research Associate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials. The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management. The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data. The CRA is responsible for preparing reports of study results for investigators and internal development teams, assisting in preparation of regulatory submissions, and supporting publication activities. The CRA will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities. Responsibilities: Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products. Provide product development teams and other functions with technical and clinical expertise and support. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures. Specific Responsibilities: Develop the study design and protocol(s) Screen, select, and qualify principal investigators and investigational sites Conduct negotiations of clinical site agreements and contracts Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials Develop time schedules and budgets necessary to manage the clinical evaluations Coordinate and plan availability of supplies and shipment of materials Train clinical evaluation participants in study products and procedures. Monitor sites to assure that the Protocol is understood and followed Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators Support the reporting of performance data to regulatory authorities Assumes responsibility for occasional special departmental projects Anticipate 10% to 25% travel (primarily domestic; international travel a possibility

The Communication Sciences & Disorders Department at Iona University welcomes applicants for a Clinic Coordinator. The Clinic Coordinator will report to the Speech, Language and Hearing Clinic Director to support and supervise daily office operations for the Iona University Speech, Language and Hearing Clinic. The successful candidate will have strong operational and organizational skills, be detail-oriented, and be able to manage multiple responsibilities in a fast-paced clinical and academic setting. This role requires advanced customer service, data management, problem-solving, and interpersonal and communication skills to enhance our student and client experiences. The successful candidate should have the ability to balance clinic operations with general Clinic department support, shifting between tasks and priorities while maintaining a high level of professionalism and accuracy. This position will also provide general administrative support to the Department of Communication Sciences and Disorders and report to the Department Chair for those responsibilities. Bilingual candidates are preferred. Key Responsibilities * Oversees the administrative operations of the Speech, Language, and Hearing Clinic, including scheduling, communications, documentation management, and coordination of clinic activities to ensure efficient daily operations. * Manages, processes, and tracks billing and payments, ensuring accuracy in invoicing and reconciliation of payments * Supports and manages student and staff portfolios, including maintaining accurate and up-to-date records of clinical assignments, supervision schedules, certifications, compliance documents, and professional development tracking. * Serves as the primary point of contact for clients, students, and clinical staff, providing high-quality customer service and ensuring clear, professional communication across all stakeholders. * Coordinates and maintains clinic schedules for student clinicians and supervisors; assists with posting and communicating updates, changes, and coverage needs. * Responds promptly and professionally to phone calls and emails, routing inquiries appropriately and maintaining confidentiality in compliance with HIPAA and FERPA standards. * Supports onboarding, training, and troubleshooting for the Clinic's Electronic Medical Record (EMR) system; assists users and generates reports as needed. * Oversees and supervises student workers assigned to the clinic, including scheduling, task assignment, and training to ensure adherence to clinic policies and procedures. * Coordinates communication and collaboration with other university departments (e.g., Registrar, Finance, Facilities, IT, and HR) to support clinic operations and problem resolution. * Supports departmental needs including but not limited to: * Manage and facilitate communications between department, students, and alumni * Assist with graduate student recruitment and follow-up * Assist with certification paperwork for graduate students * Maintain paperwork and provide support for graduate program accreditation, departmental grants, faculty developmental paperwork, and grant budgets * Assists with routine financial and administrative operations, including purchasing, expense tracking, and basic budget management for the clinic and department. * Assist with planning and supporting department-wide events Professional Attributes * Professionalism and discretion in all communications and interactions. * Ability to work collaboratively within a multidisciplinary team. * Initiative in identifying and implementing process improvements. * Commitment to supporting the mission and values of Iona University and the Department of Communication Sciences and Disorders.

A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Adherence and compliance to the assigned protocols at their respective site(s). Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s). Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner. Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial. Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred