Clinical Trials Specialist remote jobs

We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities. What you will be doing: Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation. Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight. Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance. Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines. Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary. Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Your profile: A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization. Bachelor's degree in health, life sciences, or other relevant fields of study. Phase 1 experience preferred At least 10+ years of relevant experience in clinical trial management. Preferred: 2+ years of monitoring experience. Experience in managing complex or global trials is advantageous. Preferred: Experience in managing all trial components from start-up to database lock. Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives. Fluency in English (reading, writing, speaking).

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

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: 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.

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. Responsibilities: Review patient clinical records and use relevant data to determine clinical trial matches. Independently manage clinical trial workflows, adapting to changing priorities and business needs to ensure efficiency and consistency. Work collaboratively with cross-functional teams at Tempus (including scientists, pathologists, and product development) to create customized clinical reports. Navigate and synthesize information from multiple data sources and systems. Ensure clinical reports are accurate, clear, and aligned with requirements. Support ongoing and future projects within the team. Contribute to a dynamic work environment by maintaining flexibility and responsiveness to shifting workflows. Other duties as assigned. Qualifications: Bachelor's or Master's degree in Genetics, Molecular Genetics, Cancer Biology, or Biological Sciences. Willingness to work flexible hours and adapt to business needs. Strong written and verbal communication skills. Proficient in critical thinking, interpersonal, and problem-solving abilities. Ability to manage complex tasks efficiently under time constraints. Highly detail-oriented with a commitment to accuracy and consistency. Self-motivated and able to thrive independently as well as within a collaborative, high-performing team. Demonstrated passion for making an impact in a fast-paced, mission-driven environment. Preferred Qualifications: Experience reviewing hematology/oncology clinical records. Experience critically evaluating clinical trials. Basic knowledge of generative AI. CHI: $46,000-$50,000 The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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

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

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

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!

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 VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level 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 $154,500.00/Yr. Max USD $249,947.00/Yr.

Piper Companies is seeking a well-rounded Clinical Research Associate with direct oncology monitoring experience to work with a Global CRO. The Clinical Research Associate will be working remote with some travel included. Requirements for the Clinical Research Associate include: * Conducting site monitoring visits in line with GCP and ICH guidelines * Ensure project needs are met by collaborating with local sites * Oversee regulatory submissions, CRF completion, and data query resolutions * Ensure documentation is properly formatted and filed; TMF and ISF * Mentor clinical staff during visits Qualifications for the Clinical Research Associate include: * 2+ years of Oncology monitoring experience * 2+ years of onsite monitoring experience * Able to travel locally for work * Proficient in GCP and ICH guidelines * Understand Microsoft Office and mobiles devices * Strong understanding of Phase 1 oncology trials (phase 2 and 3 are welcomed) * Bachelor's degree in a related field Compensation for the Clinical Research Associate includes: * Salary range: $90,000 - $120,000 * Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays Keywords: Clinical research associate, CRA, hospital, travel, oncology, documentation, trials, trial sites, cancer, cancer research, GCP, ICH, recruitment plans, projects, project, protocol adherence, regulatory submissions, enrollment, CRF completion, data, data query, start-up phase, phase 1, trial master file, TMF, Investigators site file, ISF, mentorship, Microsoft office, mobile devices #LI-BH1 #LI-REMOTE This job opens for applications on 12/8/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Clinical Research Associate 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 to join our diverse and dynamic team. As a Clinical Research Associate 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. 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. Are you a current ICON Employee? Please click here to apply

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

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

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

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. BIOTRONIK is looking to add a Regional Clinical Research Associate II to our Clinical Studies team. Responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures and IRB/EC policies and procedures) for assigned clinical studies in the field of cardiac rhythm management, vascular intervention or other therapeutic area. Your Responsibilities: Conduct assigned monitoring activities in accordance with BIOTRONIK procedures and applicable regulations to evaluate protocol compliance, data accuracy and subject safety by review of regulatory documents, medical records, reported data and device storage, if applicable. Responsible for all monitoring activities for assigned clinical studies including: Scheduling and conducting monitoring activities within specified timelines and according to the risk-based monitoring plan and BIOTRONIK procedures. Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining and resolve compliance concerns as appropriate. Works cooperatively with the BIOTRONIK Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and pro-actively provides input on site performance. Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items and study visit preparation. Trains and mentors BIOTRONIK personnel on monitoring procedures and practices. Conducts site training and co-monitoring visits as requested by management. Completes monitoring visit reports, action items and monitoring visit follow-up letters per BIOTRONIK procedures. Assists the Manager, RCRA Group with team, department and study related projects as requested including audits, investigator meetings, training, etc. Interfaces with Clinical, Regulatory, Sales and clinical site staff as necessary to accomplish the above responsibilities. Your Profile Bachelor's degree or higher level degree in nursing, life sciences or related medical/scientific field. Must have a valid US driver's license. Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device company. Experience supporting medical device IDE trials is preferred. Strong clinical trial monitoring experience in relevant BIOTRONIK product and/or relevant therapeutic areas (electrophysiology and vascular interventional cardiology) preferred. Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials. Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). Strong knowledge of medical terminology Ability to work independently in a regional area with minimal supervision Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. Ability to interact constructively in communication of adherence to protocol and regulatory requirements. Responsible for adequate and reasonable home office set up including dedicated desk space to accommodate work responsibilities and BIOTRONIK supplied equipment Travel Approximately 60% travel required throughout the United States to investigational centers and BIOTRONIK, Inc. corporate office. The travel percentage may vary based on the study requirements. Travel may be conducted via air travel, driving or train. Location Remote opportunity based on the East Coast, United States Are you interested? Please apply online through our application management system! We are looking forward to welcoming you. Location: East Coast | Working hours: Full-time | Type of contract: Undefined Apply now under: ************************* Job ID: 61606 | BIOTRONIK Inc. | United States (US) We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.

We are seeking a dedicated Clinical Research Associate (CRA) responsible for managing and monitoring clinical trial activities at assigned study sites, ensuring compliance with protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. This role involves building collaborative relationships with investigative sites to ensure subject safety, protocol compliance, and the validity of study data. Responsibilities * Serve as the primary point of contact for investigators and site staff. * Collaborate closely with sites to complete required site visits and perform site management activities to meet project timelines and deliverables. * Ensure all site management and monitoring activities comply with ICH-GCP, SOPs, Clinical Monitoring Plan, Protocol, study plans, local laws, and regulations. * Verify the accuracy and completeness of study data through source data review and verification. * Conduct site staff training and retraining on study protocol requirements and procedures. * Manage site-level queries, protocol deviations, and issues, escalating as necessary. * Ensure timely and accurate updating of data systems by sites. * Ensure timely and accurate reporting of adverse events, serious adverse events, and data safety. * Prepare and submit visit reports, follow-up letters, and other documentation promptly. * Maintain accurate and up-to-date study files, including regulatory documents and monitoring records. * Support site audits and inspections. * Support site feasibility assessments and patient recruitment strategies. * Act as a liaison between sites and sponsors, ensuring effective communication and issue resolution. * Work with sites to adapt, drive, and track the subject recruitment plan to enhance predictability. * Attend project meetings and provide updates on site status and progress. * Identify risks and recommend mitigation strategies. * Ensure events are properly followed to completion. * Lead and conduct presentations. * Coordinate, organize, and manage clinical study coordinator teleconferences as needed. Essential Skills * Bachelor's Degree in a scientific discipline or healthcare preferred. * Minimum 5 years of onsite monitoring experience. * In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, such as ICH-GCP guidelines. * Ability to travel up to 80%, including overnight stays. * Experience managing serious adverse events in collaboration with safety surveillance. * Effective organizational, communication, and interpersonal skills. * Ability to lead and conduct presentations. * Experience in clinical trial management systems (CTMS), EDC platforms, and Microsoft Office suite. * Strong analytical and problem-solving abilities. * Experience working in a fast-paced, collaborative environment. * Effective time and financial management skills. Additional Skills & Qualifications * Experience managing aspects of CRO functions is a plus. * Prior experience in patient recruitment & retention strategies and site relationship management. Work Environment Join a goals-driven, passionate group where employees strive to meet objectives in a dynamic environment. As a smaller company, there is high visibility and a performance-driven culture. We offer a rewards program with compensation, cellphone reimbursement, tuition reimbursement, a 5% matching 401K, and great benefits, backed by the financial stability of the parent company. Job Type & Location This is a Permanent position based out of Houston, TX. Pay and Benefits The pay range for this position is $140000.00 - $160000.00/yr. Other benefits are: Tuition reimbursement: 8K per year Holiday Pay 12 per year Vacation: at least 10 days annually Sick days 5 Annual performance bonus 10 - 15% Cell phone reimbursement $125 per month Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Dec 19, 2025. 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 for other accommodation options.

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

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

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: 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.