Clinical research coordinator jobs in Lowell, MA - 360 jobs

Job Posting Description The Division of Genetics and Genomics at Boston Children's Hospital is seeking an experienced Clinical Research Coordinator to assist with clinical research projects that focus on Angelman syndrome in both children and adults. The primary role will be to oversee the operations of a large investigator-initiated, multi-center natural history study of Angelman Syndrome. Key Responsibilities Assisting Principal Investigators (PI) with designing and implementing clinical research protocols, including: coordinating the preparation of protocol applications for Institutional Review Board (IRB) submissions, managing stakeholder contracts, ensuring regulatory compliance across study sites, and overseeing the day-to-day activities of the study. Delivering regular updates and progress reports to PIs and sponsors, including organizing and leading steering committee sessions focused on continuous improvement. Conducting virtual and in-person study site visits (pre-study, initiation, monitoring, and close-out) and ensuring sites complete deliverables within given timelines. Maintaining multiple study databases by coordinating data entry and updates, optimizing data retrieval processes, and enhancing user interface and system performance. Routinely review and verify study data for accuracy and completeness. Creating and implementing subject recruitment and enrollment strategies for study sites. Developing case report forms (CRFs), protocols, training manuals, and other study related documents. Preparing conference presentations and manuscripts by cleaning and preparing datasets for analyses. Minimum Qualifications Education: Bachelor's Degree required, Master's Degree preferred Experience: Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience Strong quantitative and analytical skills, including use of statistical software and programming languages such as R or Python Interested in working with children and adults with severe physical and intellectual disabilities, and their families Excellent interpersonal as well as oral and written communication skills Willingness to work flexible hours, as and when required

The (Senior) Clinical Trial Manager will be based in Boston and work within the clinical trial team to provide trial oversight in the European region. They will ensure deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Associate Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration. Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans. Work closely with external collaboration partners with a focus on relationship management and efficiency Lead the proactive identification, assessment, and management of clinical study challenges and risks. Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution. Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable. Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met. Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc. Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study. Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics. Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc. Contribute to and/or author clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority / Ethics Committee questions. Qualifications Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 3-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry. Experience in oncology studies and/or Phase 3 trials highly preferred. Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors. Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details. Experience and ability to manage global or regional teams in a virtual environment. Experience with Phase 2 to Phase 3 studies highly preferred. Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues. Must be adaptable and enjoy working in a fast-paced environment. Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables. Willingness to travel up to 10-20% of the time. Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit**************** follow us on LinkedIn or X. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Job Title: Clinical Research Associate (CRA) - Oncology Reports to: Director of Clinical Operations Our client is a Boston-based biotechnology company dedicated to developing innovative oncology therapies that address unmet medical needs. The team is driven by scientific rigor, patient-centricity, and collaboration to advance cutting-edge cancer treatments from early development through late-stage clinical trials. Position Summary The Clinical Research Associate (CRA) will support the planning, execution, and monitoring of oncology clinical trials in compliance with ICH-GCP, FDA regulations, and company SOPs. The CRA will serve as a key liaison between investigative sites and the clinical operations team, ensuring data integrity, patient safety, and operational excellence across assigned studies. Key Responsibilities Conduct site qualification, initiation, monitoring, and close-out visits for oncology clinical trials Ensure protocol compliance, data accuracy, informed consent integrity, and patient safety Monitor AE/SAE reporting, protocol deviations, and essential documentation Train and support site staff and maintain strong site relationships Review and maintain study documentation and Trial Master File (TMF) Track site performance, identify risks, and proactively resolve issues Collaborate cross-functionally and provide timely monitoring reports Support audit and inspection readiness Qualifications Bachelor's degree/Master's degree in Life Sciences, Nursing, or a related field (required) 2+ years of CRA experience in clinical research (oncology preferred) Experience monitoring interventional clinical trials (Phase I-III preferred) Knowledge of Good Clinical Practices (GCP), clinical monitoring, study site oversight and management. Strong knowledge of ICH-GCP and FDA regulations Excellent communication, organizational, and problem-solving skills Ability to manage multiple sites and travel up to 30% Offer Salary 100-150k (depending on level of experience) Career development opportunities in a growing oncology-focused organization Collaborative, mission-driven work environment in the Boston biotech hub

A leading biopharmaceutical company is seeking a Head of Research Quality to provide strategic oversight and leadership within their Research Quality organization. This role is crucial in defining, executing, and overseeing compliance and integrity in non-clinical research activities. The ideal candidate will have extensive experience in the biopharma sector, excellent leadership and communication skills, and a strong understanding of global regulations. This position is based in Boston, MA, offering a competitive salary range of $208,200 - $327,140, along with comprehensive benefits including medical insurance and a 401(k) plan. #J-18808-Ljbffr

Clinical Research Coordinator III, Clinical Research Network Schedule: 40 hours per week, Hybrid ABOUT BMC: At Boston Medical Center (BMC), our diverse staff works together for one goal - to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience. You'll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth. POSITION SUMMARY: The Clinical Research Coordinator (CRC) III will perform research activities using approved techniques. The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports. Will also assist with audits and quality improvement projects. JOB RESPONSIBILITIES: * Evaluating and tracking the eligibility of all patients seen in the clinic. Obtaining informed consent (for non-treatment studies) and registering patients to cohort studies and other protocols. * Reviewing and abstracting the medical records for patients, including review of pathology reports. * Entering information into EMR and eCRF systems and departmental systems in an accurate manner. Reviewing data for quality and completeness based on established queries. * Assists with the coordination of the collection, processing, organization, and storage of biological specimens in the systems * May be responsible for IRB and regulatory submissions and maintenance of regulatory files. Maintaining on-going communications with research managers and PIs for data collection needs. OTHER: * Special Continuous Project Responsibilities-QA/QI The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required JOB REQUIREMENTS EDUCATION: * Baccalaureate Degree Required * Master's Degree and 5 years of relevant experience OR * Bachelor's Degree and 7+ years of relevant experience EXPERIENCE: * CRC III: Expert Level Position KNOWLEDGE AND SKILLS: * Excellent organization and communications skills required. * Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts. * Must be detail oriented and have the ability to follow-through. * Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times. JOB BENEFITS: Competitive pay Tuition reimbursement and tuition remission programs Highly subsidized medical, dental, and vision insurance options Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research. Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science. ABOUT THE DEPARTMENT: As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn't dictate health. Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to ************************* or call ************ to let us know the nature of your request. Compensation Range: $43,000.00- $62,000.00 This range offers an estimate based on the minimum job qualifications. However, our approach to determining base pay is comprehensive, and a broad range of factors is considered when making an offer. This includes education, experience, skills, and certifications/licensures as they directly relate to position requirements; as well as business/organizational needs, internal equity, and market-competitiveness. In addition, BMCHS offers generous total compensation that includes, but is not limited to, benefits (medical, dental, vision, pharmacy), discretionary annual bonuses and merit increases, Flexible Spending Accounts, 403(b) savings matches, paid time off, career advancement opportunities, and resources to support employee and family well-being. NOTE: This range is based on Boston-area data, and is subject to modification based on geographic location. Equal Opportunity Employer/Disabled/Veterans According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received only through our website. We do not ask or require downloads of any applications, or "apps" job offers are not extended over text messages or social media platforms. We do not ask individuals to purchase equipment for or prior to employment.

Boston University invites applications for a faculty position at the rank of non-tenure track Clinical Associate Professor in the Finance Department in the Questrom School of Business. The anticipated start date for this position is July 1, 2026. We seek outstanding candidates who would be comfortable with, stimulated by, and engaged with both graduate and undergraduate students as well as corporate partners. Candidates with relevant experience in the industry are encouraged to apply. Faculty will be expected to teach undergraduate and graduate courses in asset pricing and corporate finance. The candidate is expected to engage with the MSc in Finance, including academic direction of this program. Applicants must possess, or be near completion of, a PhD in Finance or a related field by the start of employment. Salary will be commensurate with experience. The Questrom School of Business offers generous research and teaching support. The salary range for Clinical Associate Professors at the Questrom School of Business is $174,100 - $202,520. Since its founding in 1839, Boston University has embraced a mission of openness and access, becoming one of the first universities in the nation to welcome all students of ability regardless of race, gender, or creed. That tradition shapes our enduring commitment to academic freedom, free inquiry, and the robust exchange of ideas. We seek scholars who will contribute to our community of teachers and researchers through excellence in innovative scholarship, engaged teaching, and participation in the intellectual life of the University. Boston University provides an environment where faculty and students work together across disciplines, perspectives, and experiences to advance knowledge and address society's most pressing challenges. Required Skills We seek outstanding candidates who would be comfortable with, stimulated by, and engaged with both graduate and undergraduate students as well as corporate partners. Candidates with relevant experience in the industry are encouraged to apply. Faculty will be expected to teach undergraduate and graduate courses in asset pricing and corporate finance. The candidate is expected to engage with the MSc in Finance, including academic direction of this program. Applicants must possess, or be near completion of, a PhD in Finance or a related field by the start of employment. How to Apply Applicants should submit a cover letter specifying the position the candidate is applying for, a complete curriculum vitae, three reference letters, and up to three recent publications or working papers in electronic (PDF) format to *****************. While we will accept applications until we fill the position, we strongly encourage interested candidates to apply by January 30, 2026. To ensure full consideration, candidates are encouraged to apply early. Boston University is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, age, national origin, ethnicity, disability, veteran status, or any other characteristic protected by law or identified in the University's Notice of Non-Discrimination. Retaliation is also prohibited. We are a VEVRAA Federal Contractor. Under Massachusetts law, we may not require or administer a lie detector test as a condition of employment or continued employment. Boston University, consistent with the AAU's Principles on Preventing Sexual Harassment, conducts background checks for final candidates for certain faculty and staff positions. As part of this process, we ask current and past employers of the last seven years whether there has been a substantiated finding of sexual misconduct under their policies. To move forward, final candidates must complete and sign an "Authorization to Release Information" form after receiving an offer to enable this background check.

Site: The Brigham and Women's Hospital, Inc. 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. to support new cardiovascular clinical trials Job Summary The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff. Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required. Qualifications - External 1. Bachelor's Degree 2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred 3. Knowledge of federal and institutional policies governing human clinical research 4. Proficiency with PCs and windows-based software, including Word, Excel and data management system • Be fluent in English and Spanish (preferred) • Excellent interpersonal skills and ability to work effectively in team environments. • Strong organizational skills with ability to multi-task • Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions • Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds • Accomplished documentation skills with meticulous attention to detail • Ability to complete tasks with aggressive deadlines and competing priorities • Ability to safeguard confidential information. • Comfortable with hospital in-patient and out-patient environments EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. 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. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Clinical Research or Compliance experience 3-5 years required Knowledge, Skills and Abilities - Exceptional time management and organization skills. - Excellent written and verbal communication skills. - Knowledge of current and developing clinical research trends. - Sound interpersonal skills and the ability to mentor others. - Ability to identify problems and develop solutions. - Demonstrated ability to successfully manage multiple projects. Additional Job Details (if applicable) Remote Type Onsite Work Location 350 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 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 Brigham and Women's Hospital, Inc. 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.

Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a 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 highly preferred. * 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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail. Responsibilities: The primary responsibilities of the Verve Associate Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions. Collaborate with pharmacokineticists and statisticians by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens. Clinical Research/Trial Execution and Support Design and oversee implementation of Phase lb and Ila/IIb clinical studies. Design and write clinical trial protocols. Participate in investigator identification and selection, in conjunction with clinical team. Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials. Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions Leads internal meetings to review topics and develop mitigation plans Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Scientific Data Dissemination/Exchange Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination and preparation of final reports. Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response. Business/ customer support Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis. Participate in patent development. Scientific & Technical Expertise and Continued Development Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule. Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects. Attend scientific symposia. Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Basic Requirements: Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Minimum of two years' experience in clinical development Additional Skills/Preferences: 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following: Minimum 2 of which is in clinical development Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices. Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution. Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making. Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders. Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings. Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs). Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus. Ability to travel to clinical sites, conferences, and regulatory meetings as needed. Fluent in English, verbal and written communication Additional Information: Travel 10-15% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: * 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. * Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations * 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 * Schedule and prepare for monitoring visits with sponsors * Organize and prepare for internal and external audits * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed under general supervision by the Clinical Research Manager: * 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 * Submit Data and Safety Monitoring Reports * 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 * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects' rights and individual needs Job Summary Summary Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. Does this position require Patient Care? No Essential Functions * 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. * Participate in monitoring visits and maintain a record of all correspondence related to these visits. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Research Related Experience 1-2 years preferred Knowledge, Skills and Abilities * Attention to detail. * Ability to recognize compliance and data integrity issues and respond appropriately. * Working knowledge of clinical research protocols. * Ability to communicate effectively with patients, vendors, contract research organizations and professional staff. * Effective interpersonal and communication skills. Additional Job Details (if applicable) Physical Requirements * Standing Frequently (34-66%) * Walking Frequently (34-66%) * Sitting Occasionally (3-33%) * Lifting Frequently (34-66%) 35lbs+ (w/assisted device) * Carrying Frequently (34-66%) 20lbs - 35lbs * Pushing Occasionally (3-33%) * Pulling Occasionally (3-33%) * Climbing Rarely (Less than 2%) * Balancing Frequently (34-66%) * Stooping Occasionally (3-33%) * Kneeling Occasionally (3-33%) * Crouching Occasionally (3-33%) * Crawling Rarely (Less than 2%) * Reaching Frequently (34-66%) * Gross Manipulation (Handling) Frequently (34-66%) * Fine Manipulation (Fingering) Frequently (34-66%) * Feeling Constantly (67-100%) * Foot Use Rarely (Less than 2%) * Vision - Far Constantly (67-100%) * Vision - Near Constantly (67-100%) * Talking Constantly (67-100%) * Hearing Constantly (67-100%) Remote Type Hybrid Work Location 101 Merrimac Street Pay Range $20.16 - $29.01/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

The Rosamund Stone Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is seeking a dynamic and innovative Senior Clinical Research Coordinator to join our team. The TNC strives to improve the lives of all children with neurodevelopmental disorders by fostering timely and efficient translational research. The Sr. Clinical Research Coordinator will collaborate with Principal Investigators and study stakeholders to manage the daily operations of research studies and will develop and oversee the implementation of best practice guidelines for conducting various research protocols. The Sr. Clinical Research Coordinator will contribute to the development of budgets and monitor study finances, oversee maintenance of research equipment, and ensure compliance with hospital and governmental regulations. The Sr. Clinical Research Coordinator will identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and act as a leader in overseeing their resolution. The Sr. Clinical Research Coordinator will manage and train research staff and conduct the Performance Management process. Key Responsibilities: * In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents. * Responsible for daily operations of the study. Develops and implements processes and procedures to meet study goals and protocol requirements. Participate in training and prepare study related training materials. Plans and prioritizes the work of administrative and support personnel on all clinical study activities. * Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families. Communicates all policies and procedures and responds to all inquiries. Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study. Provide input for updates of SOPs and drafting of new quality documentation. * Assist with developing and implementing best practice guidelines for conducting various clinical research protocols. Presents and prepares training materials as part of the sponsored educational efforts. * Provides analytical, data management, and methodological support to Principal Investigator and/or designees in the development of clinical research protocols and data management tools. Manages data for single and/or multi-institutional investigations. * Develops study-specific data management and quality assurance procedures and monitors their implementation at site visits and/or periodic review of study data management reports. Education: * A BA/BS degree in health, psychology or a related field is required, Master's Degree is preferred. Experience: * Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience. * Knowledge of clinical research processes and best practices. * Exceptional organizational skills and multi-tasking abilities, with good attention to detail. * The ability to take initiative and work with minimal direct supervision. * Ability to work collaboratively with multi-disciplinary project teams. * Ability to communicate effectively both orally and in writing. The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

The (Senior) Clinical Trial Manager will be based in Boston and work within the clinical trial team to provide trial oversight in the European region. They will ensure deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Associate Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration. Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans. Work closely with external collaboration partners with a focus on relationship management and efficiency Lead the proactive identification, assessment, and management of clinical study challenges and risks. Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution. Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable. Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met. Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc. Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study. Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics. Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc. Contribute to and/or author clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority / Ethics Committee questions. Qualifications Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 3-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry. Experience in oncology studies and/or Phase 3 trials highly preferred. Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors. Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details. Experience and ability to manage global or regional teams in a virtual environment. Experience with Phase 2 to Phase 3 studies highly preferred. Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues. Must be adaptable and enjoy working in a fast-paced environment. Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables. Willingness to travel up to 10-20% of the time. Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit ************** or follow us on LinkedIn or X. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Job Posting Description This clinical research program aims to define and treat neurologic sequalae of complex medical conditions including congenital heart disease, extreme prematurity, and multisystem inflammatory syndrome in children (MIS-C). The lab carries out in-depth neurophenotyping including neurodevelopmental/neuropsychologic evaluation, neuroimaging (i.e., brain MRI), and genetic/genomic evaluations to elucidate the neurobiological underpinnings of complex pediatric conditions. This lab affords the opportunity to work with an interdisciplinary team of physicians, neuropsychologists, public health professionals, and statisticians. Key Responsibilities: Overseeing acquisition and analysis of neuroimaging data for all ongoing projects ranging from fetal through adolescence. Training and supervising clinical research assistants in carrying out neuroimaging analysis. Supporting study design, data management, statistical analysis, and manuscript preparation in collaboration with PI and statisticians. Manage and oversee the work of research studies. Serves as research Study/Trial Manager for one or more large, clinical studies. Assist Principal Investigators in the design, development, and conduct of research studies. Collaborates with Principal Investigators and central staff on developing and writing grants and protocols. Assist in developing curriculum and may conduct seminars/talks to train research staff in research regulations and best practices. Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures. Conduct staff Performance Reviews. Minimum Qualifications Education: A Bachelor's Degree is required with 6 years of work experience, or a Master's Degree and 4 years of experience is required. Experience: Neuroimaging analysis. Basic statistical analysis. Manuscript writing. REDCap.

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. Under the general direction of the Principal Investigator and Research Nurse Manager, the Senior Clinical Research Coordinator serves as a lead team member, subject matter expert and trial coordinator. Designs, implements, and coordinates both industry and physician sponsored research trials. This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the study protocols. Implements the research protocol through study closeout and ensures data validation, regulatory compliance, and quality control. Experience: A minimum of 3-5 years of clinical research experience is required. Computer proficiency in MS Excel, Word, Outlook, Teams required. Experience with multi-center study protocols required. Physician initiated (IDE or IND) trial experience preferred. Some direct experience working with the FDA on clinical trial audits is preferred. Working Conditions: - Office conditions: Fully onsite (to be available for study procedures). There is some travel between sites but will be mainly associated with the Boston hospital campus and 125 Nashua St. The office is temporarily moved to 125 Nashua St. Normally we sit in Boston main campus in the Edwards building. - May be required to work in clinical conditions (including the operating room). - May be exposed to minimal radiation. - May be required to attend meetings outside of regularly scheduled hours and locations, including domestic travel - On call schedule (dependent on enrolling trials) may be required. - May be requested to lift files/medical devices (less than 20 pounds). Job Summary Summary Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, provide input into determining study subject suitability, input into recruitment strategy, methodology design, statistical analyses, protocol design, and manuscript writing. Does this position require Patient Care? No Essential Functions -Independently determines the suitability of study subjects. -Develops and implements recruitment strategies. -Participates in the design of research methodology. -Plans, performs, and designs statistical analyses. -Recommends protocol changes, writes protocols, and contributes to manuscripts. -Independently performs specialized projects. Qualifications Education Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities - Ability to work more independently and as a team member. - High degree of computer literacy and analytical skills. - Ability to identify both technical and non-technical problems and develop solutions. - Ability to interpret acceptability of data results. - Highly proficient data management skills and working knowledge of data management systems. - Able to display initiative to introduce innovations to research study. - Excellent time management, organizational, interpersonal, written, and verbal communication skills. Additional Job Details (if applicable) Remote Type Onsite Work Location 125 Nashua Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail. Responsibilities: The primary responsibilities of the Verve Associate Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning * Contribute to the development of the overall strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions. * Collaborate with pharmacokineticists and statisticians by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens. Clinical Research/Trial Execution and Support * Design and oversee implementation of Phase lb and Ila/IIb clinical studies. * Design and write clinical trial protocols. * Participate in investigator identification and selection, in conjunction with clinical team. * Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials. * Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. * Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies * Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) * Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions * Leads internal meetings to review topics and develop mitigation plans * Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. * Serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Scientific Data Dissemination/Exchange * Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. * Participate in data analysis, development of scientific data dissemination and preparation of final reports. * Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies * Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities * Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response. Business/ customer support * Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis. * Participate in patent development. Scientific & Technical Expertise and Continued Development * Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule. * Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area * Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects. * Attend scientific symposia. Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Basic Requirements: * Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) * Minimum of two years' experience in clinical development Additional Skills/Preferences: * 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following: * Minimum 2 of which is in clinical development * Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices. * Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution. * Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making. * Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders. * Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings. * Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs). * Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus. * Ability to travel to clinical sites, conferences, and regulatory meetings as needed. * Fluent in English, verbal and written communication Additional Information: * Travel 10-15% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Under the general direction of the Principal Investigator and Research Nurse Manager, the Senior Clinical Research Coordinator serves as a lead team member, subject matter expert and trial coordinator. Designs, implements, and coordinates both industry and physician sponsored research trials. This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the study protocols. Implements the research protocol through study closeout and ensures data validation, regulatory compliance, and quality control. Experience: A minimum of 3-5 years of clinical research experience is required. Computer proficiency in MS Excel, Word, Outlook, Teams required. Experience with multi-center study protocols required. Physician initiated (IDE or IND) trial experience preferred. Some direct experience working with the FDA on clinical trial audits is preferred. Working Conditions: * Office conditions: Fully onsite (to be available for study procedures). There is some travel between sites but will be mainly associated with the Boston hospital campus and 125 Nashua St. The office is temporarily moved to 125 Nashua St. Normally we sit in Boston main campus in the Edwards building. * May be required to work in clinical conditions (including the operating room). - May be exposed to minimal radiation. * May be required to attend meetings outside of regularly scheduled hours and locations, including domestic travel * On call schedule (dependent on enrolling trials) may be required. * May be requested to lift files/medical devices (less than 20 pounds). Job Summary Summary Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, provide input into determining study subject suitability, input into recruitment strategy, methodology design, statistical analyses, protocol design, and manuscript writing. Does this position require Patient Care? No Essential Functions * Independently determines the suitability of study subjects. * Develops and implements recruitment strategies. * Participates in the design of research methodology. * Plans, performs, and designs statistical analyses. * Recommends protocol changes, writes protocols, and contributes to manuscripts. * Independently performs specialized projects. Qualifications Education Bachelor's Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Related post-bachelor's degree research experience 3-5 years required Knowledge, Skills and Abilities * Ability to work more independently and as a team member. * High degree of computer literacy and analytical skills. * Ability to identify both technical and non-technical problems and develop solutions. * Ability to interpret acceptability of data results. * Highly proficient data management skills and working knowledge of data management systems. * Able to display initiative to introduce innovations to research study. * Excellent time management, organizational, interpersonal, written, and verbal communication skills. Additional Job Details (if applicable) Remote Type Onsite Work Location 125 Nashua Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

The Department of Psychiatry and Behaviroal Sciences is seeking a full-time Senior Clinical Research Coordinator (Sr. CRC) for the Glahn Laboratory and Early Psychosis Investigation Center (EPICenter) at Boston Children's Hospital. This position is integral to a multidisciplinary team of healthcare professionals (researhcers and clinicians) dedicated to advancing research and treatment focused on children and adolescents with psychotic and affective disorders. By focusing on early onset psychiatric diagnoses, we aim to identify the root causes of psychiatric symptoms, and to improve treatment options and outcomes for patients and their families. The Sr. CRC will play a vital role in overseeing daily operations of multiple NIH-funded and foundation-funded studies aligned with these aims.Responsibilities include, but are not limited to: developing and implementing best practices for clinical research protocols; collaborating with the Principal Investigator to manage studies; supervising and train research staff; monitor regulatory compliance to uphold hospital and governmental standards. Our ideal candidate is committed to a long-term tenure with the Glahn Lab and brings at least four years of experience in research study design, management, and coordination. Key Responsibilities * Providing strategic oversight of a research portfolio with minimal supervision. Leading the development and implementation of clinical research projects in collaboration with Principal Investigator and/or designees to ensure targets are met on time. * Developing and implementing enrollment strategies and study documents, including IRB approved research protocols and study materials. Provide analytical, data management, and methodological support in the development of clinical research protocols and data management tools. Assist in the establishment of best practice guidelines for various clinical research protocols. * Desigining comprehensive training curriculum for research support staff and overseeing training and development initiatives. Supervise the day-to-day activities of research support personnel. * Oversee the consent and enrollment process for research study participants. Communicates all relevant policies and procedures to address participation inquiries. Evaluate the suitability and selection of prospective study candidates based on clinical knowledge. * Developing study-specific data management and quality assurance procedures, and ensure compliance at site visits and through periodic review of study data. * Potentially assist in writing grants and preparing new applications for research funding and in implementation and managing ancillary study grants. Minimum Requirements Education * A Bachelor's degree in psychology or related field, with a minimum of 4 years relevant work experience, OR Master's Degree and 2 years relevant work experience * A cover letter describing your interest in the position and articulating why you would be an excellent fit for the Glahn Lab is preferred. Experience * Strong attention to detail and organizational skills * Exceptional communication skills to convey critical information, work collaboratively on a team, and resolve conflicts effectively * Exemplary interpersonal and supervisory skills, to lead by example and mentor research support staff and to foster collaboration within the research team * Ability to manage complex data collection procedures training * Oversee participant interview covering clinically sensitive subject matter * Flexiblity to accomandate a varied schedule, including some evenings and weekends * Willingness to commit long-term to this role The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

Job Posting Description Cardiovascular Genetics Research Nurse for Pegasus Study on Natural History of Arrhythmogenic Cardiomyopathy The Research Nurse will provide specialized clinical and research support for a longitudinal natural history study investigating PKP2-associated arrhythmogenic cardiomyopathy (ARVC). This individual will coordinate and execute study-related activities involving patient recruitment, clinical assessments, biospecimen collection, data management, and follow-up, in accordance with Good Clinical Practice (GCP) and institutional regulatory requirements. The incumbent will serve as a key member of a multidisciplinary research team including cardiologists, geneticists, imaging specialists, research coordinators, and nurse practitioners, but this position will be focused exclusively on this project. Key Responsibilities Clinical and Research Coordination Coordinates the recruitment, screening, consent, and enrollment of eligible participants into the natural history study. Oversees scheduling and execution of research visits, including ECGs, cardiac imaging, blood draws, exercise testing, cardiac imaging and blood sample collection. Patients over 18 may elect to undergo a right heart catheter and myocardial biopsy. Conducts structured interviews and standardized questionnaires to capture detailed medical and family histories. Ensures the timely completion of study case report forms and source documentation in compliance with institutional and sponsor guidelines. Nursing and Patient Care Performs study-related clinical assessments and procedures within scope of nursing practice (e.g., vital signs, ECG acquisition, specimen handling). Monitors participant safety and well-being throughout study activities; promptly reports and documents adverse events. Provides education to participants and families regarding study procedures, follow-up requirements, and genetic counseling resources. Maintains strict adherence to institutional infection control, patient confidentiality, and research safety standards. Data and Regulatory Compliance Maintains study documentation and research records in accordance with institutional policy, sponsor requirements, and federal regulations (IRB, FDA, HIPAA). Participates in internal audits, data quality reviews, and monitoring visits. Supports the preparation of regulatory submissions, amendments, and annual reports. Collaborates with the research and biostatistics teams to ensure data completeness and integrity. Collaboration and Communication Serves as a central point of contact for study participants, investigators, referring clinicians, and external collaborators. Participates in team meetings, case reviews, and protocol development discussions. Contributes to manuscripts, abstracts, and presentations summarizing study findings as appropriate. Minimum Qualifications Education: Bachelor's degree in nursing (BSN) required; Master's Degree (MSN) preferred. Experience: Minimum of two to three years of relevant clinical or research nursing experience, preferably in cardiology or inherited disease research. Demonstrated knowledge of Good Clinical Practice (GCP), research ethics, and IRB processes. Proficiency in medical record systems (e.g., Epic) and electronic data capture tools (e.g., REDCap). Experience working in cardiovascular genetics or inherited arrhythmia syndromes (e.g., ARVC, HCM, LQTS). Familiarity with natural history or registry-based clinical studies. Prior experience coordinating NIH- or industry-sponsored research. License/certifications: MA RN license required. BLS certification and CITI training. Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.

The Division of Genetics and Genomics at Boston Children's Hospital is seeking an experienced Clinical Research Coordinator to assist with clinical research projects that focus on Angelman syndrome in both children and adults. The primary role will be to oversee the operations of a large investigator-initiated, multi-center natural history study of Angelman Syndrome. Key Responsibilities * Assisting Principal Investigators (PI) with designing and implementing clinical research protocols, including: coordinating the preparation of protocol applications for Institutional Review Board (IRB) submissions, managing stakeholder contracts, ensuring regulatory compliance across study sites, and overseeing the day-to-day activities of the study. * Delivering regular updates and progress reports to PIs and sponsors, including organizing and leading steering committee sessions focused on continuous improvement. * Conducting virtual and in-person study site visits (pre-study, initiation, monitoring, and close-out) and ensuring sites complete deliverables within given timelines. * Maintaining multiple study databases by coordinating data entry and updates, optimizing data retrieval processes, and enhancing user interface and system performance. * Routinely review and verify study data for accuracy and completeness. * Creating and implementing subject recruitment and enrollment strategies for study sites. * Developing case report forms (CRFs), protocols, training manuals, and other study related documents. * Preparing conference presentations and manuscripts by cleaning and preparing datasets for analyses. Minimum Qualifications Education: * Bachelor's Degree required, Master's Degree preferred Experience: * Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience * Strong quantitative and analytical skills, including use of statistical software and programming languages such as R or Python * Interested in working with children and adults with severe physical and intellectual disabilities, and their families * Excellent interpersonal as well as oral and written communication skills * Willingness to work flexible hours, as and when required The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.