Clinical Trial Manager remote jobs

A leading organization is currently seeking a skilled Clinical Trial Specialist for a Remote contract opportunity. This role is pivotal in ensuring the successful execution of clinical trials from start-up through closeout. Responsibilities: Actively involved in the performance of study feasibility assessments Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms) Manage the collection, review and approval of regulatory documents from clinical sites Coordinate investigational product release activities across clinical sites Manage and track study specific payments Create study-specific site budgets Initiate, maintain and reconcile the Trial Master File Assist in the preparation of Investigator and Study Coordinator Meetings Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs Coordinate communication of tracking information within the study team and to the clinical sites Develop and review Standard Operating Procedures Perform other duties, as needed Qualifications: Bachelor's Degree Previous experience in Clinical Trial Coordination and/or Site Management Understanding of Study Phases and general knowledge of how they apply to Clinical Development Working knowledge of ICH Good Clinical Practice guidelines Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

TargetCancer Foundation is a patient-founded non-profit organization based in Cambridge, MA that is dedicated to rare cancer research and patient support. TargetCancer Foundation directly supports initiatives at the forefront of rare cancer treatment by funding innovative research, developing patient- centric clinical studies, and by supporting patients and raising awareness for rare cancers publicly. TargetCancer Foundation (TCF) is seeking a Clinical Research Manager to join the study team for TCF- 001 TRACK (Target Rare Cancer Knowledge) and potential future studies. TCF-001 TRACK is an IRB-approved clinical trial (NCT04504604) recruiting 400 patients to study precision medicine in rare cancers. TRACK is a fully remote, decentralized trial which provides enrolled patients with genomic testing of tissue and blood, as well as treatment recommendations from a Virtual Molecular Tumor Board. The TRACK study website can be viewed at targetcancer.org/track. Position Overview: We are seeking an organized and detail-oriented Clinical Research Manager (CRM) to manage and coordinate the TRACK clinical trial, as well as future TargetCancer Foundation decentralized clinical trials. The CRM will work closely with the TargetCancer Foundation study team, the principal investigators (PIs), study participants, and others to ensure the successful execution of trials utilizing innovative, patient-centric approaches such as eConsent, remote monitoring, and digital platforms. This position requires the highest attention to detail, excellent communication and project management skills, technological aptitude, and a willingness to think creatively and innovatively in all elements of study execution and management. The CRM will also have the opportunity to assist in the development and operational design of future TargetCancer Foundation clinical studies. This position requires regular presence at TargetCancer Foundation's Cambridge, MA offices, with options for hybrid work. Key Responsibilities Trial Operations Connect with medical institutions to collect medical records of enrolled patients, and secure continuous updates to records throughout the period of the study. Support coordination of the transfer of enrolled patient tissue from treating institutions to the molecular testing partner. Coordinate mobile phlebotomy visits for enrolled patients, and distribute related blood kits. Support the implementation of decentralized trial protocols, including remote monitoring and data collection into a centralized database. Facilitate weekly Molecular Tumor Board meetings, including distribution of pre-meeting materials, meeting execution, and post meeting follow up and report development. Run weekly study team meeting calls and provide status on enrolled patients. Manage project operations across a multidisciplinary team, including tracking all aspects of the project, identifying needs, and facilitating execution of solutions. Execute on strategic priorities and think innovatively in terms of trial infrastructure, workflow, and design. Data Management Ensure accurate and timely collection of data from PRO. Perform data entry and quality checks in electronic data capture (EDC) systems. Monitor and document protocol deviations. Maintain online study task tracking database through continuous and constant updates. Participant Management Partner with other TRACK team members to coordinate the recruitment, screening, and enrollment of study participants in a decentralized model. Facilitate remote participant engagement through eConsent platforms. Serve as a key point of contact for participants, addressing questions, concerns, and logistical needs. Provide education to participants on study procedures for their ongoing participation in TRACK. Communicate with enrolled patients and provide updates on trial status and movement. Communication and Collaboration Act as a liaison between participants, investigators, and other trial stakeholders. Collaborate with technology vendors and support teams to troubleshoot issues with digital tools and platforms. Provide updates to the study team regarding participant progress, data collection, and trial milestones. Regulatory Compliance Maintain regulatory documents and ensure compliance with Good Clinical Practice (GCP) guidelines and local regulations. Ensure participant privacy and data security, adhering to HIPAA, and other relevant guidelines. Assist with Institutional Review Board (IRB)/Ethics Committee submissions and approvals as needed. Qualifications Education: Bachelor's degree in life sciences, nursing, or a related field, Master's degree preferred. Certification in clinical research (e.g., ACRP or SOCRA) preferred. Experience: 5+ years of experience in clinical research and/or project management in clinical research. Experience with decentralized or hybrid trial models is highly desirable. Experience with unique challenges faced by rare cancer patients preferred. Knowledge: Familiarity with FDA regulations for clinical trials, including decentralized trials. Understanding of decentralized trial components, including eConsent. Skills: Mission-driven attitude and creative perspective on enabling patients to get involved in research Excellent communication and interpersonal skills, particularly in virtual environments. Technological aptitude to manage and troubleshoot devices and platforms. Ability to respond to shifting priorities, navigate ambiguity, and demonstrate a high level of initiative and problem-solving skills. Employment Type: Full-time/Part-time (Flexible or remote work options available) This role is central to the success of TargetCancer Foundation's decentralized clinical trials, enabling patient-centric research while ensuring compliance, data integrity, and participant satisfaction. This is a hybrid position, based at TCF's Cambridge, MA offices, and allowing for remote work. TargetCancer Foundation is a 501c3 non-profit organization located in Cambridge, MA and is governed by a Board of Directors. More information is available at ********************* TargetCancer Foundation is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.

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.

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.

**This position's work location is remote with occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).** The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, clinical trials education, and committee management. The Clinical Trials Education Manager reports to the Director of ODQ. The Clinical Trials Education Manager is responsible for supervising and overseeing the centralized clinical research educational activities and resources for research staff of the Dana-Farber/Harvard Cancer Center (DF/HCC). The cancer center is made up of the Boston-area, Harvard-affiliated institutions including: Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Boston Children's Hospital, and Massachusetts General Hospital. Major responsibilities of the role include managing projects for and ensuring oversight over ODQ staff who coordinate the following activities: identifying educational needs for the consortium, production of educational materials and resources, conduct of live and online educational sessions, development and management of DF/HCC Policies and Operations, ODQ communications and website resources, and customer service for research staff and physician questions regarding DF/HCC policies and education requirements. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. + Chair the DF/HCC Education Subcommittee + Identifying appropriate representatives from DF/HCC member institutions + Managing committee meetings, agendas, and documentation + Working with the committee to identify educational needs and opportunities, and develop education resources in response to those needs + Oversight of education-related projects and delegation/distribution of project work amongst the committee members + Conduct of live educational activities for DF/HCC clinical research staff, including: + Scheduling topics and speakers for DF/HCC live training sessions + Recording and posting the training sessions for future viewing + Overseeing staff who coordinate meeting logistics (location, AV requirements, etc.) + Reporting metrics and statistics to the ODQ Director and senior DF/HCC leadership + Oversee the development, review, and approval process of the DF/HCC Policies and Operations, which includes the following: + Management of the Clinical Research Operations Subcommittee (CLINOPS) operations and documentation, including approval of policy decisions + Presenting feedback and recommendations from the research community and Education Subcommittee; recommending policy changes, and draft policy writing + Distribution of draft policies for comment, collection of feedback, policy document cleanup and finalization and routing policies for approval sign off + Maintaining version history of policies and operations + Announcing policy changes to the DF/HCC community and posting revised policies and operations on the DF/HCC website + Providing background or template training materials to institutional clinical trial offices to support implementation of policy changes + Developing and maintaining e-learning modules for DF/HCC required trainings and additional topics based on need. + Designing, creating, recording, and updating e-learning modules for posting to the DF/HCC website. + Ensuring training resources are updated with regulatory/policy changes. + Identifying where additional modules are needed and promoting existing educational materials + Administration of the DFCI CITI training program account + Management of the institutional CITI account + Tracking completion of required CITI training and notifying research staff whose training has lapsed or is missing + Ensure compliance with investigator annual NCI registration requirements + Oversight of ODQ staff who provide direct support to investigators with submitting registration materials in the NCI RCR system + Responsible for tracking and reporting to leadership on compliance with registration requirements and deadlines; provide proactive notifications and reminders + Escalate non-compliance to institutional clinical trials offices, institutional leaders, and CLINOPS as needed + Act as the face of ODQ for DF/HCC communications + Sending broadcast announcements as needed, including for important updates, changes, and to promote educational resources + Overseeing and curating ODQ's online presence, resources, and educational materials on the DF/HCC website + Ensuring excellence in customer service to investigators and study teams. Oversees staff who are responsible for email communications in the ODQ Education mailbox + Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is preferred. + 5 years of experience in clinical trials; oncology experience preferred + 2 years of experience supervising projects and/or staff. + Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices. **Pay Transparency Statement** The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA) $99,900 - $116,200 At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. **EEOC Poster**

Senior CTM - Boston 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 Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities. **What you will be doing:** + Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation. + Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight. + Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance. + Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines. + Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary.Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. **Your profile:** + A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization. + Bachelor's degree in health, life sciences, or other relevant fields of study. + At least 10+ years of relevant experience in clinical trial management. + Preferred: 2+ years of monitoring experience. + Experience in managing complex or global trials is advantageous. + Preferred: Experience in managing all trial components from start-up to database lock. + Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives. + Fluency in English (reading, writing, speaking). **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

Summarized Purpose: Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. Essential Functions Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities. Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department. Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines. Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities. Job Complexity: Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau. Supervision Received Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Business Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916 Strong planning and organizational skills to enable effective prioritization of workload and workload of team members Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization Solid understanding of change management principles Comprehensive understanding of the practices, processes, and requirements of clinical monitoring Strong judgment, decision making, escalation, and risk management skills Effective oral and written communication skills, including English language proficiency Capable of evaluating own and team members workload against project budget and adjust resources accordingly Strong financial acumen and knowledge of budgeting, forecasting and fiscal management Strong attention to detail In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Capable of independently managing clinical only studies Management Role: No management responsibility Working Conditions and Environment: · Work is performed in an office environment with exposure to electrical office equipment. · Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: · Frequently stationary for 6-8 hours per day. · Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. · Frequent mobility required. · Occasional crouching, stooping, bending and twisting of upper body and neck. · Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. · Ability to access and use a variety of computer software developed both in-house and off-the-shelf. · Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. · Frequently interacts with others to obtain or relate information to diverse groups. · Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. · Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. · Regular and consistent attendance. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Senior Clinical Trial Associate (SCTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, eTMF management, filing and quality reviews of study documents as well as participating in process improvement initiatives across the department. The SCTA will play a key role in working cross functionally to support the clinical teams including close collaboration with study team from vendors/CROs in completing all required tasks to meet departmental and project goals. Strong candidates will bring knowledge and experience in the fundamental aspects of trial and study site management, vendor management, and experience in the full cycle of study from start- up to close out. Key Accountabilities Assists Clinical Project Managers (CPMs) with Sponsor oversight, study-specific documentation review, and QC, including ICF, study plans, study reference manuals, eCRF, etc. Supports Investigator Initiated Trials (IITs) by providing oversight and operational support, including clinical supply forecasting, reoccurring meeting participation and preparation. May be involved in study startup, acting as a startup specialist, and leading or being the point of contact for a CRO regarding site/institutional CDAs, site feasibility questionnaires, and startup documentation. Liaises between internal medical affairs teams/MSLs and CRO/Sites. May be the point of contact for documentation or specific requests (e.g., enrollment updates, missing documentation, meeting arrangements). Supports trial submissions to applicable IRBs and regulatory health authorities, as required. Assists with creating and maintaining study metrics trackers, tools, and reports. Assists in coordinating and tracking Investigator and third-party payments. Ensures required study documents are submitted to the study (electronic) trial master file ((e) TMF). Conducts eTMF reviews for in-house studies in collaboration with the CPM. Creates Investigator Site Files (ISF) for in-house studies. Manages (e) TMF and study documents to meet GCP/ICH and internal guidelines for records retention. Acts as a CLM Super User and facilitates contract execution and management in the system. Assists CPMs with Sponsor oversight of CRO-held eTMFs, periodic audits, and findings resolution. Assists with the customization of CDAs, clinical site contracts, and budgets, when applicable. Assists CPMs and clinical teams with Investigator Meeting coordination and activity preparation. Coordinates document translation, if required. Acts as Veeva Vault owner and owns the training responsibilities to ensure that role-based training and access are granted to each internal and, when required, external stakeholder. May participate in training CRO teams and onboarding new CRO team members. Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed. May assist in or conduct study monitoring, including site qualification visits, site initiation visits, interim monitoring, etc. Other duties as assigned, including study monitoring. Education and Experience Bachelor's degree (BSc, BA or RN equivalent) in a biological or science-related field is essential. 3+ years of experience and knowledge in ICH GCP, eTMF management and DIA TMF Reference Model. Previous CTA experience working with Sponsors, CROs and/or vendors. Experience of working effectively in a fast-paced team environment. Proficiency in office suite notably Microsoft Word, Excel and PowerPoint, Veeva Vault and Smartsheet Ability to develop and/or use existing tools (e.g. tracking tool). Experience of working across functions. Excellent organizational, interpersonal and communication skills Ability to prioritize and manage multiple tasks with competing deadlines. Willingness to travel as needed ( Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires. POSITION OVERVIEW: Disc Medicine is hiring a new Clinical Trial Assistant/ Senior Clinical Trial Assistant due to the fast growth of the programs in the clinic. This position is located within Disc Medicine's Watertown, MA office, although hybrid work is currently in effect and open for this role. We are looking for someone to be an integral member of the Clinical Operations team and lead the planning, implementation, and management of early-phase clinical research studies. Excellent organization and oral/written communication skills are required, as is the ability to work in a collaborative, cross-functional team environment with both in-office and remote team members. The CTA will independently perform tasks related to supporting operational strategy, planning, and execution of clinical studies in a fully outsourced model. This position offers the chance to join a team of passionate colleagues with career growth opportunities. RESPONSIBILITIES: Provide support for critical day-to-day clinical study activities, including inspection readiness and/or oversight of inspection deliverables and/or milestones, in accordance with established protocols under the general supervision of the CTA Manager. Collaborate with the Clinical Trial Manager, study teams, vendors, and Clinical Research Organizations (CROs) to support clinical study activities defined by the clinical trial operating model. Supported the clinical trial manager with preparing and coordinating bi-weekly clinical trial team meetings and finalizing meeting materials such as agendas, slides, and meeting minutes; tracked and followed up on action items. Development and/or review and approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, laboratory manuals, pharmacy manuals, and trial status updates. Ensure audit-ready condition of clinical trial documentation, including the trial master file, and leading internal TMF quality reviews with cross-functional team members on the study-defined cadence. Track patient samples and reconcile sample discrepancies with sites and applicable central labs; coordinate sample movement and data deliverables on time with business needs and accompanying data deliverable timelines. Assist the finance department with invoices, clinical projections, and per-patient cost estimates. Work closely with the CRO to support study and site start-up activities such as SIV slide development, process flows, contract and budget negotiations, site ICF customizations, assist with answering site IRB questions, etc., to ensure start-up occurs within an established timelines. Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner. Collaborate with internal departments (Legal, Finance, Nonclinical, etc.), CROs, and external vendors. Establish and maintain trial-related processes/systems with study vendors such as central labs, clinical supplies, IP depot, and CRO as assigned per protocol requirements. Help develop and drive timelines and collaborate with cross-functional teams to align on deliverables to help support data cuts, conference needs, interim analyses, etc. Monitor the progress of clinical study activities and report on the progress of assigned clinical trials, including budget and timelines. Oversee the updating and maintenance of patient trackers to accurately reflect all enrolled, screened, and screen-failed patients within the study. Ensure timely completion of patient visits and proactively follow up with sites and CROs regarding any outstanding visits. Provide real-time patient updates to the Clinical Trial Team as needed Initiate clinicaltrials.gov updates and publications based on business needs and other study updates. Participate in the preparation and review of SOPs. Perform any other business need identified by their direct line Manager. REQUIREMENTS: BA/BS required Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally. Strong knowledge of MS Word, Excel, PowerPoint, and Outlook. Ability to effectively collaborate with both internal and external study team. Ability to take initiative and ownership of new activities as they arise. Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands. Experience working on project teams is required. Candidate should be a self-driven individual with skills in organization, building working relationships and communication. The annual base salary range for this position is listed below. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and internal parity. Salary Range $73,100 - $98,900 USD Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit ***************** and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. This is a 6-month contract opportunity with the possibility of extension or contract-to-hire. Responsibilities include, but are not limited to: * Manage all clinical aspects of study under oversight of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.). * Interface with cross-functional teams as Clinical Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial. * May oversee clinical trial execution in one or more regions within a global clinical trial. * Review protocol and amendment development, Informed Consent Forms, clinical trial-related training, and Site Study Tools * Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF * Partner with Clinical Quality Assurance to follow through on corrective and preventative actions (CAPA) identified during internal and external audits * Vendor oversight: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics * Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel. * Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary. * Prepare and present project debriefings to Clinical Operations management. * Provide study-related guidance and leadership to internal and external partners, as appropriate. Position Requirements & Experience: * Bachelor's degree or equivalent combination of education/experience in science or health-related field with at least 3 years of clinical trial management experience in a Pharmaceutical/Biotech organization. * Clinical trial management experience as a contractor or employee of an industry sponsor * Vendor management * Robust understanding of ICH/GCP, and knowledge of regulatory requirements. * Strong clinical study/project management skills. * Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills. * Candidates must be authorized to work in the U.S. Preferred experience: * Prior clinical trial experience in oncology therapeutic development with an industry sponsor or Contract Research Organization * Multi-regional study management experience advantageous We offer a chance to work with talented people in a collaborative environment. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-EL1 #LI-REMOTE

Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experience and skills line up. If everything is a go, please apply and the Talent Acquisition team will contact you for an interview so we can also get to know you better. - Your Human Resources Team Let's talk about some of the key responsibilities of the role: Oversees and manages key study activities including study start-up, development of study plans, vendors, drug inventory, lab supplies, non-clinical study supplies, lab sample management, and screening and enrollment activity. Involved in the review of protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms, and any other study-related documents as assigned; participates in user acceptance testing for eCRFs and recommends operational changes as required. Develops key study documents: training materials, site study materials, and related study documentation. Assists in the identification, selection, and site qualification processes of study sites. Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study; help train the study staff in conducting the study per GCP and in performing procedures per protocol. Arranges and oversees site visits. When monitoring has been delegated to a CRO, provides Sponsor oversight of monitoring activities. Organizes and makes presentations at site initiation visits and/or Investigator Meetings. Manages and tracks all drug supply inventory (e.g., storage, distribution, site inventory, etc.) and updates supply tracking with projection vs usage. Reviews study budgets and tracks, processes, and manages vendor invoices in support of study financial tracking. Assists in the creation of project tools, tracking tools, etc. to report and oversee study specific metrics as needed. Reviews and assists in the preparation of Clinical Study Reports (CSRs). May serve as a resource for others within the company for clinical trials management expertise. Factors for Success: Bachelor's degree (life science preferred) and five years clinical experience or Associate's degree and 7 years clinical experience. Minimum of 2 years of clinical research experience at a Pharmaceutical, Biotech, or CRO company. Experience managing outside vendors (e.g., CROs and labs). Thorough knowledge of ICH/GCP R2 Guidelines and working knowledge of health authority requirements and regulations. Demonstrated ability to attain and maintain a working knowledge of applicable Standard Operating Procedures at Tarsus and with CRO/vendors. Ability to work independently as well as collaboratively in an efficient manner. Skillful in prioritizing workflow with different demands to meet deadlines in an accurate and timely manner. Flexibility to adjust to changing needs in the Clinical Department and organization. Excellent knowledge of MS Office, Excel, and PowerPoint Strict attention to detail. A Few Other Details Worth Mentioning: The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option. We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact! This position reports directly to our Associate Director, Clinical Operations. Some travel may be required - up to 20% At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $93,700 - $131,300 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap. #LI-Hybrid #LI-Remote

Let's talk about some of the key responsibilities of the role: Oversees and manages key study activities including study start-up, development of study plans, vendors, drug inventory, lab supplies, non-clinical study supplies, lab sample management, and screening and enrollment activity. Involved in the review of protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms, and any other study-related documents as assigned; participates in user acceptance testing for eCRFs and recommends operational changes as required. Develops key study documents: training materials, site study materials, and related study documentation. Assists in the identification, selection, and site qualification processes of study sites. Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study; help train the study staff in conducting the study per GCP and in performing procedures per protocol. Arranges and oversees site visits. When monitoring has been delegated to a CRO, provides Sponsor oversight of monitoring activities. Organizes and makes presentations at site initiation visits and/or Investigator Meetings. Manages and tracks all drug supply inventory (e.g., storage, distribution, site inventory, etc.) and updates supply tracking with projection vs usage. Reviews study budgets and tracks, processes, and manages vendor invoices in support of study financial tracking. Assists in the creation of project tools, tracking tools, etc. to report and oversee study specific metrics as needed. Reviews and assists in the preparation of Clinical Study Reports (CSRs). May serve as a resource for others within the company for clinical trials management expertise. Factors for Success: Bachelor's degree (life science preferred) and five years clinical experience or Associate's degree and 7 years clinical experience. Minimum of 2 years of clinical research experience at a Pharmaceutical, Biotech, or CRO company. Experience managing outside vendors (e.g., CROs and labs). Thorough knowledge of ICH/GCP R2 Guidelines and working knowledge of health authority requirements and regulations. Demonstrated ability to attain and maintain a working knowledge of applicable Standard Operating Procedures at Tarsus and with CRO/vendors. Ability to work independently as well as collaboratively in an efficient manner. Skillful in prioritizing workflow with different demands to meet deadlines in an accurate and timely manner. Flexibility to adjust to changing needs in the Clinical Department and organization. Excellent knowledge of MS Office, Excel, and PowerPoint Strict attention to detail. A Few Other Details Worth Mentioning: The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option. We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact! This position reports directly to our Associate Director, Clinical Operations. Some travel may be required - up to 20% At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $93,700 - $131,300 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: ************************************************ #LI-Hybrid #LI-Remote Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role Vitalief is seeking a highly organized and detail-oriented Mid-Level Project Manager to provide operational oversight and coordination for our client's Pediatric Acute Leukemia clinical trials. This full-time, fully benefited role serves as the primary liaison between the pharmaceutical clinical research team and CROs, ensuring trials are executed efficiently, on budget, and in compliance with regulatory standards. The Project Manager bridges scientific and operational aspects of clinical research, leading cross-functional teams to deliver high-quality studies evaluating the safety and efficacy of pharmaceuticals. WHY VITALIEF? Contribute to advancing scientific discoveries that improve patient lives. PEOPLE FIRST culture with opportunities for growth and innovation. Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Salary Range: $70,000 to $80,000 (commensurate with experience). Work Location: 100% Remote (seeking only candidates that live in the EST Zone). KEY RESPONSIBILITIES Trial Planning and Initiation Support bid strategies and contract discussions with CROs, including site selection and patient enrollment. Review and finalize trial protocols and related documents. Build project plans, timelines, and vendor assessments. Establish and maintain collaborative relationships with sponsors, CROs, vendors, investigators, and site staff. Trial Execution and Management Monitor study activities for compliance with protocols and regulatory requirements. Identify potential delays or out-of-scope work and implement mitigations. Manage study risks and escalate issues to leadership as needed. Oversee study documentation, including case report forms, drug records, and regulatory filings. Motivate team members and investigators to achieve trial objectives. Stakeholder Management Maintain regular communication with sponsors and internal teams. Conduct status meetings and provide updates to leadership and stakeholders. Develop realistic budgets and timelines. Quality and Compliance Ensure audit readiness and compliance with ICH/GCP, FDA, IRB/IEC, and SOP requirements. Review monitoring reports and support development of study materials, processes, and committees. Anticipate and mitigate project risks. QUALIFICATIONS Education and Experience Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred. 5 or more years of clinical research experience, including oversight of multicenter or complex studies; oncology experience highly preferred. 2 or more years of experience in a clinical trials oversight capacity as a project manager, ideally working for a sponsor or a CRO. Project management certification (CCPM or PMP) preferred. Knowledge of clinical trial practices and project management principles. Strong organizational, communication, and interpersonal skills. Ability to manage multiple projects, deadlines, and budgets effectively. Proven leadership and collaboration skills in multi-level team settings. Problem-solving and decision-making abilities in fast-paced, dynamic environments. PHYSICAL DEMANDS: Prolonged periods sitting working on a computer, standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.

The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. Perform departmental tasks. Perform developmental tasks with oversight of CTA Manager. ACCOUNTABILITIES: For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Support oversight of risk-based monitoring. Attend important team meetings. Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.) Support additional ad-hoc activities, as agreed with CTA Manager. Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors. Escalate clinical trial insurance issues. Support Health Care Provider Engagement for facilitating contracts and meetings. Support vendor contract administration. Requirements Bachelor's degree or equivalent international degree. 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role. Experience in Phase 2 and 3 studies and global/international studies is advantageous. Experience working across multiple therapeutic areas is advantageous. Knowledge in global regulatory and compliance requirements for clinical research. Excellence in task management and collaboration. Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis. Benefits 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! CLINICAL TRIAL MANAGEMENT (CTMA) SUMMARY: The Clinical Trial Management Associate (CTMA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials. RESPONSIBILITIES: * Conducts study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals * Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes * Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.) * Collects and reviews essential documents from Investigational sites * Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents * Participates in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation * Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites * Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies * Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution * Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.) * Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs) * Keeps the Clinical Project Lead (CPL) informed of the progress of projects * Develops and maintains good working relationships with Investigators and study staff * Assists in the organization and preparation of and participates in Investigator Meetings (as applicable) * Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation * Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed * Ensures timely study entry and updates to ClinicalTrials.gov * Assists with design and preparation of study related materials for the training of internal and external staff * Participates in co-monitoring activities and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring, and closeout visits * Assists with the tracking and management of study specific budgets * Participates in development of departmental processes, SOPs, and initiatives * Assists with facilitating resolution of data queries and requests from Clinical Data Management * Travel is variable and estimated at 20% COMPETENCIES IDENTIFIED FOR SUCCESS: * Ability to work in a team or independently as required * Effective written and verbal communication skills * Critically evaluates job tasks and the impact on overall trial management objectives * Sound problem-solving capabilities * Good judgment in triaging issues from internal and external customers * Effectively collaborates with Clinical Trial Team members * Outstanding organizational skills with the ability to multi-task and prioritize * Exceptional attention to detail * Proven flexibility and adaptability REQUIREMENTS: * Bachelor's Degree preferred * Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus * Experience in scientific discipline and multiple therapeutic areas preferred * Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process * Proficiency in MS Office including Word, Excel, and PowerPoint Please visit our website, ******************** for more information about Ionis and to apply for this position; reference requisition # IONIS003866 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: ************************************************************************************************************************ The pay scale for this position is $84,240 to $118,308 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

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 • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

SummaryAs the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionEssential Responsibilities: Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership Support adoption of new technology or clinical applications through advocacy and evidence Participate in customer presentations regarding use of Interventional products for institution research purposes Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns Grow technology leadership mindshare through joint scientific presentations and publications Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products Study new technology concepts and leverage expertise to move initiatives forward Qualifications/Requirements: PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research Knowledge of Interventional procedures, anatomies, clinical practice Knowledge of Interventional products including IGS product line and Advantage Windows applications Excellent customer relationship management and collaboration skills Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Desired Characteristics: 5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes

Stanford Cancer Institute - Clinical Trials Office - Clinical Research Manager - GI Oncology (Hybrid Work Schedule) The Stanford Cancer Institute (SCI) was re-designated as a comprehensive cancer center by the NCI in early 2022, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Manager for GI Oncology to help us enact our mission to reduce cancer mortality through comprehensive cancer research, treatment, education, and outreach programs. Given the SCI's mission, breadth, and depth, we thrive in a fast-paced, team-oriented, and forward-thinking environment, employing over 375 staff with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral component of the SCI. This vital work enables our adult and pediatric cancer centers to translate research from the laboratory into clinical settings. You will be working with a world-class community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. Reporting to an Associate Director of Clinical Research, the Clinical Research Manager (CRM) GI Oncology will support cancer clinical research focused in oncology. The CRM will be conversant in the goals, mission, and priorities of the Institute and utilize this knowledge to conduct impactful clinical research focusing on high quality and efficiency. We are seeking candidates with excellent organizational skills, attention to detail, and a willingness to learn. Candidates must be eager to take on challenges with a high degree of professionalism, initiative, and flexibility. Responsibilities include working with the research team, clinical staff, and Stanford Health Care departments to support safe and compliant clinical research. Duties include*: * Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators. * Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures. * Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel. * Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required. * Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. * Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group. * Lead or chair committees or task forces to address and resolve significant issues. * Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. * Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance. * Assist with analysis of data and preparation of manuscripts and scientific presentations. * - Other duties may also be assigned. DESIRED QUALIFICATIONS: * Clinical research certification. * Previous experience in oncology, specifically GI oncology. * Experience with clinical trial finance management. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): * Excellent interpersonal skills. * Proficiency in Microsoft Office and database applications. * Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. * Knowledge of medical terminology. * Demonstrated managerial experience. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. PHYSICAL REQUIREMENTS*: * Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. * Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. * Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: * Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. * May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS: * Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. * Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. * Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************* The expected pay range for this position is $124,521 to $153,615 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (***************************************************** provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Additional Information * Schedule: Full-time * Job Code: 4926 * Employee Status: Regular * Grade: J * Requisition ID: 107873 * Work Arrangement : Hybrid Eligible

The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.