Clinical Trial Manager remote jobs - 289 jobs

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. GENERAL SUMMARY/ OVERVIEW STATEMENT: The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work. Job Summary PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties will be performed under general supervision by the Clinical Research Manager. The following clinical duties will be performed: · Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients · Coordinating the collection and processing of tissue samples and blood samples from patients · Consent patients to translational research studies (minimal risk specimen collection studies) · Explain study protocol to patients and obtain informed consent · Screen and follow patients relevant to specific projects/studies · Assist clinical team in screening potential patients for study participation · Schedule all protocol required tests and procedures · Consent patients to specimen collection protocols · Coordinate patient appointments with physicians, nurses, and all test areas · Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers · Prepare pre-visit communication for providers to ensure required assessments are completed and documented · Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation · Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition · Coordinate, obtain, process, and ship protocol required blood and tissue samples · Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL) The following data management responsibilities will be performed: · Collecting detailed clinical and treatment information on patients who are undergoing genetic testing, receiving treatments for cancer, or are enrolled in a research study · Maintaining an updated and organized database of patients · Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria · Enroll patients as required by the study sponsor and internal enrollment monitor team · Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance · Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. · Maintain research charts and/or electronic files for all enrolled patients · Ensure adequate source documentation is in place for all data reported · Resolve data queries issued by the sponsor · Obtain protocol clarifications from the study sponsor and communicate information to the research team · Facilitate the request and shipment of samples · Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies · Assist in abstracts, presentations, and manuscripts The following regulatory duties may be performed: · Assist with new study submission · Assist with updates and/or changes to current studies · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment documentation · Prepare monthly enrollment and data summary for study team SKILLS/ABILITIES/COMPETENCIES REQUIRED: · Ability to be self-motivated to work independently and as a team member · Analytical skills and ability to resolve problems · Careful attention to detail · Excellent organizational skills · Ability to follow directions · Excellent verbal and written communication skills · Computer literacy · Working knowledge of clinical research protocols · Ability to demonstrate respect and professionalism for subjects rights and individual needs Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Clinical Research or compliance experience 1-2 years preferred Knowledge, Skills and Abilities - Ability to work independently and as a team member. - Analytical skills and ability to resolve problems. - Ability to interpret acceptability of data results. - Careful attention to detail. - Good organizational and communication skills. - Working knowledge of clinical research protocols. Additional Job Details (if applicable) WORKING CONDITIONS: · Duties will be performed primarily on-site in ambulatory/clinical office setting · Components of the data/regulatory role may allow for remote work. Remote Type Hybrid Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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.

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn's lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 2 study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Position Overview: The Clinical Trial Assistant will provide general administrative and project support for clinical research studies. He/she will provide day-to-day operational support to the Clinical Operations and Study Management teams across Avalyn's clinical trials spanning PH 1-2b and beyond. This role will support study start-up, ongoing study conduct, and close-out activities in close collaboration with CRO partners, external vendors, and internal cross-functional teams. The Clinical Trial Assistant will help coordinate global clinical trial activities by tracking key study milestones, deliverables, and timelines across investigational sites, and will assist in the preparation and organization of study materials for Investigator Meetings, Site Initiation Visits (SIVs), and other study-related meetings and communications. Responsibilities: · Support TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC and reconciliation (through life of the trial and final reconciliation) Including conducting TMF audits based on the timing outlined in the applicable study plans communicating issues identified to the CRO and tracking resolution of the identified issues. · Create and maintain a SharePoint study file organization structure; build a file folder format consistent with TMF reference model to use consistently across all trials. · Assist with study start-up, maintenance, and close-out activities in collaboration with CROs, vendors, and internal cross-functional teams. · Responsible for coordination of meetings and generate meeting minutes · Will assist in building Smartsheet or similar workspaces to house various study specific trackers allowing for a central location · Responsible for supporting Data Review, identifying gaps/missing data, outliers, etc) to ensure accuracy of data. Track and report status of issues to resolution, escalating when appropriate. · Support GCP compliance and inspection readiness activities by ensuring study documentation is complete, accurate, and well organized. · Assist with internal audits, inspection preparation activities, and responses to audit findings as needed. Required Qualifications: · Minimum of Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field (or equivalent relevant experience) · 2+ years of experience in Clinical Operations, Clinical Research, or a related clinical trial support role (industry or CRO) · Working knowledge of clinical trial documentation and Trial Master File (TMF) requirements including the CDISC TMF reference model · Experience supporting TMF activities, including document collection, filing, tracking, and basic QC · Familiarity with electronic TMF (eTMF) systems and document management best practices · Experience with TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC (set a frequency through life of the trial and final recon) · Ability to build, maintain, and update study trackers (e.g., Excel, Smartsheet, or similar tools) · Strong attention to detail with the ability to identify missing, inconsistent, or incomplete information · Excellent organizational, time management, and prioritization skills · Strong written and verbal communication skills, including the ability to document meeting minutes clearly and concisely · Ability to work collaboratively, as well as independently. with cross-functional teams, CROs, and external vendors · Must be familiar with ICH GCP and appropriate regulations · Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) Proposed pay range$90,000-$125,000 USD

Job Title: Clinical Study LeadJob Description This role will be responsible for the regional operational execution, oversight, and management of one or more clinical trials from start-up through close out for Our Client's early-stage clinical programs. As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology, and Translational Science to ensure the successful completion of all clinical activities and project deliverables. You will apply your technical skills and play a key role in clinical trial planning and execution, helping to grow Our Client's pipeline. Responsibilities + Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. + Collaborate with SET to develop, review, and facilitate RFPs, and contribute to bid defense meetings for selecting CROs and other clinical vendors. + Manage various clinical vendors to achieve project and corporate goals on time. + Actively manage and resolve site issues in collaboration with Our Client's functional lines and CRO partners. + Contribute to the development and review of key clinical documents such as protocols and informed consent forms. + Serve as a subject matter expert on various company/department initiatives and participate in SOP and process development. + Oversee and manage vendor contracts, forecast financials, reconcile invoices, and ensure accuracy of CRO/vendor work orders. + Participate in the implementation and oversight of clinical systems including CTMS, TMF, EDC, and IRT. + Conduct clinical data reviews, generate queries, and participate in study activities such as site selection and start-up. + Provide input and support in the development and review of key study documents and track study metrics. + Proactively identify potential study risks, recommend mitigation strategies, and facilitate discussions for implementation. + Train investigators, site staff, vendors, and team members on study protocols and trial conduct processes. + Ensure the Trial Master File is set up and maintained, and participate in Quality Assurance and regulatory audits. + Perform other duties as assigned. Essential Skills + Bachelor's degree in life sciences or a related discipline with 6+ years of experience in clinical and drug development. + Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology. + Experience with early phase oncology trial management, including precision medicine trials. + Self-motivated with a focus on continuous improvement and innovative thinking. + Results-oriented team player with strong collaboration and relationship-building skills. + Detail-oriented and creative thinker with a passion for process optimization. + Excellent organizational, analytical, and communication skills in a fast-paced environment. + Ability to analyze and prioritize problems and propose solutions. + Willingness to travel as required (up to 40%). Additional Skills & Qualifications + Experience in site management and early phase oncology trial management preferred. + Advanced knowledge of FDA and ICH/GCP regulations and guidelines. Work Environment Must work West Coast hours. The position can be fully remote. Job Type & Location This is a Contract position based out of Remote, OR. Pay and Benefits The pay range for this position is $65.00 - $88.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jan 23, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

REMOTE: We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. We have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. 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!

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 Clinical Research Associate II/ Sr. Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Salary range: $110,520.00-$138,150.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

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

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. The Role Headlands Research is seeking a Clinical Intake Specialist who can combine their clinical expertise with strong communication skills to screen prequalified participants for clinical research studies. The ideal candidate will have prior experience working in a psychiatric practice environment, with active involvement in the care of these patients. Duties/Responsibilities Conduct virtual video and/or phone visits with potential participants to assess eligibility for clinical research trials based on study inclusion and exclusion criteria across multiple trials. Collect and document detailed and comprehensive medical history, including but not limited to reviewing medical records, screening results, current and past diagnoses, medications, allergies, lifestyle habits, etc. Utilize clinical judgment to determine if potential participants meet inclusion and exclusion criteria to move them forward to participate in the trial. Accurately enter collected participant information into our Clinical Trial Management System (we use CRIO) while maintaining proper documentation practices Coordinate with study site team members to schedule participant on-site screening appointments. Answer participant questions , address concerns, and provide necessary information to potential participants Requirements: Master's degree in Psychology OR current and unencumbered license to practice as a Nurse Practitioner or Physician Assistant within the United States required. Minimum of 5 years of work experience providing extensive care for psychiatric patients. Familiar with diagnostic criteria and assessments to determine them per the DSM-5 Prior experience administering common psychiatric rating scales including but not limited to: Hamilton Depression Rating Scale (Ham-D) Hamilton Anxiety Rating Scale (Ham-A) Montgomery-Asberg Depression Rating Scale (MADRS) Mini International Neuropsychiatric Interview (M.I.N.I) Structured Clinical Interview for DSM Disorders-Clinical Trails (SCID-CT) Mini Mental State Exam (MMSE) Clinical Global Impression Scales (CGI-S, CGI-C, CGI-I) Must be tech-savvy and able to seamlessly work in a fully remote position using multiple systems. Highly experienced with EMRs; experience with Clinical Trial Management Systems preferred Experience with a CTMS system, CRIO preferred Excellent communication and interpersonal skills to build rapport with potential participants over the phone. Strong attention to detail to accurately capture and record medical information. Ability to navigate complex medical terminology and understand clinical research protocols, inclusion/exclusion criteria, and prohibited medications. Knowledge of HIPAA regulations and Good Clinical Practice (GCP) guidelines Strong oral, written, and interpersonal communication skills and ability to understand and apply protocol Inclusion and Exclusion criteria to each participant Bilingual preferred

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies. Essential Functions Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals. Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems. Collaborate with Clinical Trials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinical trial documentation issues. Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival. Review clinical trial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents. Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. Audit Investigator/Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission. Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval. Facilitate the collection and review of required study documents during site start-up Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) Route study documents to the appropriate personnel for validated digital signatures Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee. Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions. Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree with 0-2 years of clinical research experience required; or High school diploma with 5+ years of clinical research experience required Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills as well as strong organizational and multi-tasking skills Maintain corporate confidentiality at all times. Strong oral and written communication skills Detail oriented, with solid organization and time management skills Working knowledge of good documentation practices (GDP) Working Environment / Physical Environment This position works on site in El Segundo, CA or remotely depending on the candidate's geographic location Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $70,000 (entry-level qualifications) to $77,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $73,800 (entry-level qualifications) to $81,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Clinical Trials Contracts Associate I (Remote) Rate: $25-$30/hour | Fully Remote We are seeking a Clinical Trials Contracts Associate I to join our team and support the contracting process for clinical trials. This role is fully remote and involves both frontline and backend administrative duties to ensure smooth and compliant contract operations. Key Responsibilities * Contract Administration: Review, process, and maintain clinical trial contracts and related documentation. * Collaboration: Work closely with clinical research teams, sponsors, and site staff to facilitate negotiations. * Communication: Serve as a point of contact for stakeholders, providing updates on contract status. * Process Improvement: Identify opportunities to streamline workflows and enhance efficiency. * Contract Reconciliation: Research discrepancies, track pending agreements, and support execution steps. Qualifications * Education: Bachelor's degree in business, healthcare, or life sciences. * Experience: 1-3 years in contract administration, clinical trials, or related field preferred. * Skills: Strong attention to detail, organizational ability, and excellent verbal/written communication. * Problem-Solving: Ability to identify issues and propose solutions in a fast-paced environment. Why Join Us This role offers the opportunity to contribute to the success of clinical research initiatives while working remotely. You'll play a vital part in ensuring contractual obligations are met and supporting teams that advance healthcare innovation. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide. Employee Type: Contract Remote: Yes Location: Memphis, TN, US Job Type: Scientific and Clinical Date Posted: December 11, 2025 Pay Range: $25 - $30 per hour Similar Jobs * Sr. Clinical Study Associate III * Contracts Manager * Associate Instock Manager - Associate Instock Manager I * Clinical Exercise Physiologist * Director of Clinical Solutions

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

The Senior Clinical Research Manager (CRM) provides strategic and operational oversight of the adult medical oncology clinical trial portfolio across six regional satellite locations within the Greater Boston and Southern New Hampshire areas, including Brighton, Milford, Weymouth, Methuen, Foxborough, MA & Londonderry, NH and any future satellite regional campus. The role is responsible for leading and managing the clinical research programs at these sites and for supervising the research staff engaged in the conduct of clinical trials in accordance with Good Clinical Practice, under the direction of the Principal Investigators and the Regional Campus Leadership Team. In close collaboration with the regional campus medical director, the research physician leads at each campus, and research nursing staff, the Senior CRM is responsible for the implementation and evaluation of both therapeutic and non-therapeutic clinical research activities, ensuring robust regulatory and compliance oversight. The Senior CRM provides direct supervision and professional development for the program's clinical research staff and is responsible for monitoring and achieving clinical trial performance benchmarks, including protocol and regulatory compliance, patient safety, staff training and development, and financial targets, as defined by Senior Research Leadership and the Regional Campus Leadership Team. This position's work location is primarily onsite traveling to DFCI regional sites in Brighton, Milford, Weymouth, Methuen, Foxborough, MA & Londonderry, NH, and any future regional campus location. This role will be up to 1 day remote per week. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). The individual selected for the position will be required to have regular presence across the regional locations and be available to work onsite at various campuses throughout the work week. 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. **Primary Duties and Responsibilities:** _Clinical Trials Operations_ - Clinical Research Managers (CRM) are responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements. - The CRM will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate. The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials. - The CRM will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution. - The CRM will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds. - Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials. - In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile all study and related grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing. - Assists the principal investigator in preparing manuscripts for publication. - The CRM will collaborate with the DFCI CTO, and DF/HCC ODQ to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials - The CRM will oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients. - Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol. - If applicable for coverage or trial assignments, responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed. - Responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System. The data entry oversight may include, but is not limited to, Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc. _Regulatory & Compliance_ - Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance. - Assumes responsibilities for all clinical trial reporting requirements, safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance. - Responsible for the disease group's transition from paper to electronic regulatory binders. Will maintain per DFCI CTO standards. _Data Management & Clinical Trial Monitoring_ - Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection. - Regularly reports data compliance status to key stakeholders, i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance when necessary. - Submits required "progress / tracking" reports to key stakeholders, when applicable. _Staff Hiring, Supervision, Training & Development_ - Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff. - Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting. Will develop and agenda, take attendance and document all applicable meetings. - Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up. **Knowledge, Skills and Abilities:** Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. In addition, has experience in protocol development, data compilation and analysis. The Manager will be skilled at developing tracking systems to ensure timely data management by the clinical research staff. They will also have expert knowledge of Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required. Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and OnCore applications. **Minimum Job Qualifications:** Bachelor's Degree required, with a minimum of 7 years of related experience or Master Degree with 5 years experience. **Supervisory Responsibilities:** Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants. Number of Direct Reports 10 **Patient Contact:** May have contact with patients of all ages and populations. 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 committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate 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. **EEO Poster** . 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). $105,400.00 - $130,500.00

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

How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level. What will you do? CLINICAL SITE MONITORING Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits Assist with selection of potential investigators Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed Evaluate investigator compliance with the study protocol and applicable regulations Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed Verify and reconcile site's essential documents against the trial master file as required Oversee and conduct monitoring activities, including remote monitoring when applicable Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study CLINICAL SITE MANAGEMENT Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites. Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans Ensure audit and inspection readiness of assigned sites Advise on pre-audit activities for GCP requirements Be familiar with assigned study timelines and communicate potential issues to study management How will you get here? Works independently with minimal supervision Conducts all types of site visits Build strong productive relationships with study investigators, site staff, and study management personnel Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinical research experience Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA Knowledge and understanding of Good Clinical Practices (ICH E6 R2) Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies Must have proficient computer skills and experience with Microsoft Office Must be willing and able to travel approximately 75-80%, including overnight, domestic and international Must have Self-directed behavior #GKOSUS

**School of Medicine, Stanford, California, United States** Research Post Date Dec 08, 2025 Requisition # 107873 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 the salary or hourly wage the university reasonably expects to pay for a position upon hire. 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**

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. GENERAL SUMMARY/ OVERVIEW STATEMENT: The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work. Job Summary PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties will be performed under general supervision by the Clinical Research Manager. The following clinical duties will be performed: * Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients * Coordinating the collection and processing of tissue samples and blood samples from patients * Consent patients to translational research studies (minimal risk specimen collection studies) * Explain study protocol to patients and obtain informed consent * Screen and follow patients relevant to specific projects/studies * Assist clinical team in screening potential patients for study participation * Schedule all protocol required tests and procedures * Consent patients to specimen collection protocols * Coordinate patient appointments with physicians, nurses, and all test areas * Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers * Prepare pre-visit communication for providers to ensure required assessments are completed and documented * Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation * Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition * Coordinate, obtain, process, and ship protocol required blood and tissue samples * Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL) The following data management responsibilities will be performed: * Collecting detailed clinical and treatment information on patients who are undergoing genetic testing, receiving treatments for cancer, or are enrolled in a research study * Maintaining an updated and organized database of patients * Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria * Enroll patients as required by the study sponsor and internal enrollment monitor team * Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance * Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. * Maintain research charts and/or electronic files for all enrolled patients * Ensure adequate source documentation is in place for all data reported * Resolve data queries issued by the sponsor * Obtain protocol clarifications from the study sponsor and communicate information to the research team * Facilitate the request and shipment of samples * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies * Assist in abstracts, presentations, and manuscripts The following regulatory duties may be performed: * Assist with new study submission * Assist with updates and/or changes to current studies * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment documentation * Prepare monthly enrollment and data summary for study team SKILLS/ABILITIES/COMPETENCIES REQUIRED: * Ability to be self-motivated to work independently and as a team member * Analytical skills and ability to resolve problems * Careful attention to detail * Excellent organizational skills * Ability to follow directions * Excellent verbal and written communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects rights and individual needs Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Clinical Research or compliance experience 1-2 years preferred Knowledge, Skills and Abilities * Ability to work independently and as a team member. * Analytical skills and ability to resolve problems. * Ability to interpret acceptability of data results. * Careful attention to detail. * Good organizational and communication skills. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) WORKING CONDITIONS: * Duties will be performed primarily on-site in ambulatory/clinical office setting * Components of the data/regulatory role may allow for remote work. Remote Type Hybrid Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote