Clinical research coordinator jobs in New Bedford, MA - 335 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.

Site: The Spaulding Rehabilitation 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 Spaulding HealthSpan Lab at Spaulding Rehabilitation Hospital, directed by Dr. Daniel Daneshvar, is seeking a Clinical Research Coordinator (CRC) to support studies and clinical programs focused on brain and body health across the lifespan. The lab investigates how repeated head impacts and traumatic brain injuries affect long-term neurological and physical health, with particular attention to conditions such as chronic traumatic encephalopathy (CTE) and amyotrophic lateral sclerosis (ALS), and to factors that influence recovery and HealthSpan. In addition to supporting research within the HealthSpan Lab and the Rehabilitation Outcomes Center (ROCS), the CRC will play a key role in the NFL Players Association (NFLPA) Brain and Body Program, a multidisciplinary clinical initiative providing comprehensive evaluations for retired professional athletes. The coordinator will assist with participant recruitment, scheduling, data management, and integration of clinical and research workflows across these programs. Candidates should have a bachelor's degree, strong organizational and communication skills, and experience in clinical research or public health. Backgrounds in neurology, rehabilitation, or sports medicine are preferred. Job Summary Summary 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. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. Recruiting patients for clinical trials, conducts phone interviews. Verifies the accuracy of study forms and updates them per protocol. Prepares data for analysis and data entry. Documents patient visits and procedures. Assists with regulatory binders and QA/QC Procedures. Assists with interviewing study subjects. Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required. Can this role accept experience in lieu of a degree? Yes. Experience Some relevant research project work 0-1 year preferred. Knowledge, Skills and Abilities Careful attention to detail and good organizational skills. Ability to follow directions. Good interpersonal and communication skills. Computer literacy. Working knowledge of clinical research protocols. Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Remote Type Hybrid Work Location 300 First Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1400 The Spaulding Rehabilitation 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.

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 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.

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

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

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Community Focused. Care Driven. Join Southcoast Health, where your future is as promising as the care we provide. Our commitment to each other, our patients, and our community is more than a mission - it's our way of life, and you'll be at the heart of it. Southcoast Health is a not-for-profit, charitable, health system with multiple hospitals, clinics and facilities throughout Southeastern Massachusetts and Rhode Island. Nestled in local communities, Southcoast Health provides inclusive, ethical workplaces where our highly skilled caregivers offer world-class, comprehensive healthcare close to home. Find out for yourself why Southcoast Health has been voted 'Best Place to Work' for 7 years in a row! We are searching for a talented Clinical Research Coordinator-CV This is an onsite role A career at Southcoast Health offers you: * A culture of well-being that embraces, respects, and celebrates the rich diversity of one another and the communities we serve * Competitive pay and comprehensive benefits package * Generous Earned Time Off Package * Employee Wellbeing Program * 403B Retirement Plan with company match * Tuition assistance / Federal Loan Forgiveness programs * Professional growth opportunities and customized leadership training Available to regular status employees who are scheduled to work a minimum of 24 hours. Southcoast Health is an Equal Opportunity Employer. Responsibilities Under the direction of the Care Center Director or Designee, perform diversified duties in coordinating all activities related to clinical trials. Duties include but are not limited to oversight of all research-related activities, screening and evaluation of prospective trial patients, clinical follow-up of enrolled trial patients, correspondence and coordination with the Institutional Review Board and trial sponsors. Facilitation and development of relationships with Sponsors for clinical trials. Management/tracking of compliance with Federal and institution guidelines relating to conducting human subject research. Educate patients to clinical trials and obtain informed consent to participate. Responsible for implementing new trials, collaborating with multiple MD Principal Investigators, negotiating and maintaining budgets, managing audits and ensuring adherence to study protocols about mandated visits, medicine management and symptom tracking. Qualifications * Bachelors Degree or the equivalent experience is required. * Degree in Healthcare administration, Healthcare, Science or related field is preferred. * Three to five years of experience working directly in clinical trials involving human subjects is preferred. * Attention to detail and strong organizational skills are required. * US Drivers license is required. * Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) is preferred. * Certification within 6 months of hire. * If less than 2 years full time clinical research experience, the minimum allowed before you can sit for the exam, certification will then be required. * Must be fully vaccinated against seasonal Influenza and the COVID 19 virus or to be exempt from the requirement for medical or personal reasons by signing a statement certifying you are choosing to be exempt from vaccination once hired Compensation: Pay rate will be determined based on level of experience. Pay Range USD $57,553.60 - USD $96,761.60 /Yr. Rotation Schedule Requirement M-F

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. General Summary/Overview Statement: The 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. Working Conditions: Remote Job Summary Principal Duties and Responsibilities: 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 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) Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 0100 Mass General Brigham Incorporated 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.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Patient Coordination Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Prescreen study candidates Obtain informed consent per Care Access Research SOP . Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Assist in the creation and review of source documents. Patient Recruitment Assist with planning and creation of appropriate recruitment materials. Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct Communicate clearly verbally and in writing Attend Investigator meetings as required Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required Ability to understand and follow institutional SOPs. Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Licenses: California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in Warwick, Rhode Island Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of travel required: Regional (within 100 miles) Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Walking - 20% Standing - 20% Sitting - 20% Lifting - 20% Up to 25lbs Over 25lbs Overhead Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

This is Part-Time; 24 hours/week role Under direct supervision of the Senior Clinical Research Accounts Specialist, the Clinical Research Accounting Coordinator is responsible for accounts creation and accounts receivable of financial transactions generated from Dana-Farber Cancer Institute Clinical Research activity. Handles basic issues and problems and refers more complex issues to higher -level staff. In the absence of a Senior Clinical Research Accounts Specialist this position is under direct supervision of the Clinical Research Accounting Manager. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. **Primary Duties and Responsibilities:** + Submits study financial account creation requests for each new Clinical Research contract budget in a timely manner, as necessary. + Maintains master list of study account numbers with applicable study IRB numbers for tracking and reporting purpose. + Maintains an updated list of payment contacts for all studies and funding sources, as applicable. + Monitors study payment activity and consistently pursues collections from extramural research sponsors and funding sources on all open accounts receivables to ensure timely payments. + Tracks, documents, and reports payment collection follow up with study funding sources while maintaining accurate and organized accounts receivable files. + Organizes and maintains the Clinical Research Accounting central e-mailbox; Responds to study accounts receivable and payment status inquiries via e-mail communications. + Receives Clinical Research checks and wire payments; identifies and enters payments received to the correct study record in the Clinical Trial Management System (CTMS); Stores copies of all payments received for financial reconciliation purpose; submits payments to Finance for study account deposit. + Prepares accounts receivable and other financial reports, forecasts, and analyses, as instructed. + Handles basic issues and problems and refers more complex issues to higher level Clinical Research Accounting team members; escalates invoice revision and justification requests to the applicable Clinical Research Accounting Specialist. **Knowledge, Skills and Abilities:** + Effective oral and written communication skills. + Good listening skills. + Ability to perform basic math and accounting skills + Strong organization skills and attention to detail. + Proficiency in data entry and Microsoft Office Suite (especially Excel) + Ability to analyze and interpret financial data accurately **Minimum Job Qualifications:** + High school diploma required + Bachelor's degree in accounting or finance preferred + No experience required + Working knowledge of the clinical trials lifecycle preferred **License/Certification/Registration Required:** MCA Certification within 1-year of hire **Supervisory Responsibilities:** None **Patient Contact:** No At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. **EEO Poster** . Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA). $50,800.00 - $59,400.00

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area. Job Overview This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. Our team within the Division of Endocrinology focuses on studies to improve care for people with diabetes, thyroid disorders, and other endocrine conditions through a mix of industry-sponsored and investigator-initiated research studies. We're a close-knit group, made up of multiple Principal Investigators, a senior clinical coordinator, and a clinical studies manager, who enjoy the day-to-day work of discovery and take pride in conducting studies with integrity and a mindset for continuous improvement. The coordinator plays a role in bringing clinical research to life by keeping studies organized and on track - recruiting and meeting with participants, collecting and managing data. This position is an excellent opportunity for someone interested in clinical research who is curious, detail-oriented, reliable, and eager to learn in a supportive and fast-paced environment. The Division of Endocrinology consistently scores high in employee satisfaction surveys, and the successful candidate is expected to embody the three qualities that define our culture: kindness, effectiveness, and genuine fun to work with. Job Description Minimum Qualifications: 1. Bachelor's degree OR High School Diploma or equivalent AND Four (4) years of related experience. 2. Basic Life Support (BLS) certification may be required based on specific role requirements. Preferred Qualifications: 1. Two (2) years in research related activities. 2. IATA Hazardous Good Shipping certification. 3. CITI Human Research Protection certification. Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned. 1. Assists in the recruitment of study participants. 2. Completes follow up with study participants in prescribed settings as required. 3. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. 4. Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board. 5. Assists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews. 6. Performs basic laboratory activities as needed. 7. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. 8. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor. 9. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. 10. Participates in site visits with the study sponsor to review completeness and accuracy of study documentation. 11. Maintains inventory of all study supplies. 12. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. 13. Reviews all eligibility and ineligibility criteria in the patient's record. 14. Verifies information with the physician. 15. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form. 16. Conducts a QC check of completed CRFs prior to submission for data entry. 17. Coordinates resolution of all data queries. 18. Completes data entry as warranted. 19. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc. Physical Requirements: 1. Typical clinical and administrative office setting. Skills & Abilities: 1. High degree of organizational talents, data collection, and analysis skills. 2. Requires meticulous attention to detail. 3. Excellent computer skills including word processing. 4. Ability to prioritize quickly and appropriately. 5. Excellent communication and interpersonal skills. 6. Systematic record-keeping. At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day. The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals. Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth-one of the many ways we invest in you so you can thrive both at work and outside of it. Pay Range: $44,778.55 - $55,978.47

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.

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.