Clinical research coordinator jobs in New Bedford, MA

**Phase I vaccine experience preferred** ** fast paced studies** ** 10 site visits a month** The Senior CRA will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Responsibilities: Applies knowledge of ICON's policies and procedures Demonstrates excellent written and oral communication Demonstrates excellent knowledge of ICH/GCP Displays ability to manage investigative sites to facilitate trial deliverables Demonstrates ability to escalate issues appropriately Conducts monitoring to confirm subject safety and data integrity Describes and demonstrates the principals of IP accountability Identifies scientific misconduct at the site level Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms Mentors CRAs new to the position or company Serves as an observation visit leader Conducts monitoring evaluation visits Assists team lead in the development of trial tools or documents Assists with CTM tasks Participates in the development of process changes/improvements Presents at client meetings/Investigator meetings Provides training to trial teams 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.

MDC Associates ("MDC") is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world. The Clinical Research Associate is highly motivated and organized individual with a proven history executing IVD clinical studies. The CRA will be tasked to conduct site qualification, site initiation, interim monitoring and close out visits to clinical sites. The ideal candidate will have a keen understanding of the nuances of IVD clinical studies and will conduct all clinical trials in accordance with Good Clinical Practices and study protocol requirements. Primary Responsibilities Develop and conduct site training on protocol requirements, source documentation completion, and electronic data capture (EDC). Conduct regular site monitoring visits (virtually and physically) and prepare reports for study initiation, monitoring, and close-out visits. Ensure site adherence to study protocols and regulatory requirements. Draft and/or provide input into Clinical Study Protocols, supporting plans and procedures, including Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team. Assist with Institutional Review Board (IRB) management. Manage study budget and agreements with study sites. Manage study Trial Master Files. Serve as primary point of contact with study sites. Monitor and analyze clinical study data and report on performance to the project team. Assist with the development of study databases for managing clinical data. Qualifications BA, BS, or Master's degree in Life Sciences, Data Science, Statistics, or a related field (preferred). 2+ years' relevant clinical study experience in the medical devices industry or pharmaceuticals industry with specific experience in in vitro diagnostic devices a plus. ACRP or similar certification a plus but not required. Knowledge and Skills In depth knowledge of, and experience in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines. Understanding of U.S. Food and Drug Administration (FDA) laws and guidance pertaining to clinical studies. Understanding of IRB guidelines and Common Rule. Ability to learn applicable protocol requirements as provided in company training. Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint. Strong written and verbal communication skills including good command of English language. Excellent organizational and problem-solving skills. Effective time management skills. Attention to detail and accuracy in work. Ability to manage competing priorities without compromising quality. Ability to establish and maintain effective collaborative relationships with coworkers, managers and clients. Travel Requirements Up to 75% travel including local, within U.S and outside of the US. Travel may include: Attending clinical site Initiation, interim and close out monitoring visits Attending annual industry conferences (i.e.: Association of Clinical Research Professionals) Pay Compensation commensurate with experience. Employee Stock Options Benefits Medical, Dental, and Vision Insurance. Health Reimbursement Account (HRA) Flexible Spending (FSA) / Dependent Care Accounts (DCA) Short and Long-Term Disability Group Term Life Insurance 401(k) with Safe Harbor Match Unlimited PTO Paid Holidays Equal Opportunity Employer MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.

Clinic Coordinator Location:450 Brookline Ave, Boston, MA 02215 Category:Administration Support/Customer Service Employment Type:full time Clinic Coordinators demonstrate the values and mission of Dana-Farber everyday by providing expert compassionate care to our patients with cancer. Responsibilities: Create an exceptional patient experience by delivering outstanding customer service throughout the check in and check out process. Manage complex scheduling to meet patient needs. Act as a liaison for patients, families and providers. Respond to emergent and compliance matters with creative problem solving and critical thinking. Qualifications Bachelor's degree preferred. 0 - 1 year experience in a customer service setting. Proficiency in technology and complex computer systems required. Ability to work in a fast paced and complex clinical environment. Professional Growth: The Clinic Coordinator position may lead to career opportunities in administrative, team lead, and management roles. Dana-Farber is committed to offering a variety of personal, professional, and leadership development opportunities to all members of its workforce to meet the everchanging needs of our workforce and our industry. Well-Being and Benefits Health, Dental and Vision Insurance Time Off Family & Child Care Benefits and Resources Retirement Programs Life Insurance Short Term Disability Health Savings Account Flexible Spending Account Transportation LGBTQ+ Our Benefits Partners Include: Harvard Pilgram Health Care Delta Dental Eye Med Fidelity Investments Sentinel Benefits Group Prudential Voya Financial TIAA Care.com Edukate Headspace At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Join Our Talent Network Stay connected with Dana-Farber and receive alerts with new job opportunities and news relative to your interests.

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. to support new cardiovascular clinical trials Job Summary The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff. Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required. Qualifications - External 1. Bachelor's Degree 2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred 3. Knowledge of federal and institutional policies governing human clinical research 4. Proficiency with PCs and windows-based software, including Word, Excel and data management system • Be fluent in English and Spanish (preferred) • Excellent interpersonal skills and ability to work effectively in team environments. • Strong organizational skills with ability to multi-task • Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions • Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds • Accomplished documentation skills with meticulous attention to detail • Ability to complete tasks with aggressive deadlines and competing priorities • Ability to safeguard confidential information. • Comfortable with hospital in-patient and out-patient environments EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Clinical Research or Compliance experience 3-5 years required Knowledge, Skills and Abilities - Exceptional time management and organization skills. - Excellent written and verbal communication skills. - Knowledge of current and developing clinical research trends. - Sound interpersonal skills and the ability to mentor others. - Ability to identify problems and develop solutions. - Demonstrated ability to successfully manage multiple projects. Additional Job Details (if applicable) Remote Type Onsite Work Location 350 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field highly preferred. + Minimum of 2 years of experience as a Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

The Computational Health Informatics Program (CHIP) is seeking an experienced, highly motivated Senior Clinical Research Coordinator (Enroller) to support a flagship initiative developing and evaluating new methods to bring population-level evidence into everyday clinical practice. This is a rare opportunity to join one of the most influential teams in biomedical informatics and open-source health IT-a group whose work has shaped how data are used across healthcare and who is now building the next generation of data-supported care. In this role, you will work closely with patients, families, and a wide range of clinical teams, supporting enrollment, coordinating data collection, and ensuring that study activities fit the realities of clinical workflow. You will be part of a fast-moving, collaborative environment in which clinicians, data scientists, and research staff work side by side to test tools that will ultimately be used across the country. You will feel the direct impact of your work-not only in each patient interaction, but in advancing a national capability that aims to improve care for children everywhere Key Responsibilities * In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents. * Responsible for daily operations of the study. Develops and implements processes and procedures to meet study goals and protocol requirements. Participate in training and prepare study related training materials. Plans and prioritizes the work of administrative and support personnel on all clinical study activities. * Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families. Communicates all policies and procedures and responds to all inquiries. Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study. Provide input for updates of SOPs and drafting of new quality documentation. * Assist with developing and implementing best practice guidelines for conducting various clinical research protocols. Presents and prepares training materials as part of the sponsored educational efforts. * Provides analytical, data management, and methodological support to Principal Investigator and/or designees in the development of clinical research protocols and data management tools. Manages data for single and/or multi-institutional investigations. * Develops study specific data management and quality assurance procedures and monitors their implementation at site visits and/or periodic review of study data management reports. * Works with Principal Investigators and lab members to plan analyses, clean and verify data and facilitate preparation of datasets for analyses. * May assist in writing grants. Prepare new applications for research funding and in implementation and managing ancillary study grants. Minimum Qualifications Education: * Bachelor's degree, Master's preferred. Experience: * Bachelor's degree and 4 years of relevant work experience OR Master's degree and 2 years of relevant work experience. * Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex. * Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions. * Ability to effectively engage with and influence others; build working relationships and can work independently and as a team member, leads others when needed. * Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures. The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

Job Description 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 into 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 DifferenceThe Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact Ability to understand and follow institutional SOPs Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff Assist with planning and creation of appropriate recruitment and marketing materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives Assist in the creation or review of protocol specific source documents Determine facility, equipment and outsource vendor requirements and availability Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records Collect and evaluate concomitant medications Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion Maintain effective relationships with study participants and other Care Access personnel Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management Strong and clear communication skills, both verbally and in writing Accept accountability for actions and function independently Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial Administer delegated study questionnaires, where appropriate. Collect and evaluate medical records with the support of medically qualified members of the study team. Complete visit procedures and ensure proper specimen collection, processing and shipment 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 Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. Monitor patient progress on study medication Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart Accurately transcribe data to CRF or EDC. Resolve data management queries and correct source data as needed Record protocol exemptions and deviations as appropriate with sponsor. Complete Note(s)-to-File for patient chart and regulatory filing if necessary Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with completion of continuing/final review reports Perform other duties as assigned. The Expertise Required Excellent working knowledge of clinical trials, medicine and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ 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. Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. 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: BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred RN or LPN preferred Research Professional Certification- CRCC or exam eligibility preferred A minimum of 3 to 4 years Clinical Research experience A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together Location: This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide. Travel: Duties may require travel in the following models: Two weeks on / One week off deployments Temporary Event Support (3-7-day deployment durations) Weekly deployments (one week on, 2-5 days off). Frequency and length of travel may depend on the length and location of study, site, and event. Deployments normalize to a 32 to 42-hour work week on average. The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. 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: ********************************

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. to support new cardiovascular clinical trials Job Summary The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff. Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required. Qualifications - External 1. Bachelor's Degree 2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred 3. Knowledge of federal and institutional policies governing human clinical research 4. Proficiency with PCs and windows-based software, including Word, Excel and data management system * Be fluent in English and Spanish (preferred) * Excellent interpersonal skills and ability to work effectively in team environments. * Strong organizational skills with ability to multi-task * Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions * Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds * Accomplished documentation skills with meticulous attention to detail * Ability to complete tasks with aggressive deadlines and competing priorities * Ability to safeguard confidential information. * Comfortable with hospital in-patient and out-patient environments EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Clinical Research or Compliance experience 3-5 years required Knowledge, Skills and Abilities * Exceptional time management and organization skills. * Excellent written and verbal communication skills. * Knowledge of current and developing clinical research trends. * Sound interpersonal skills and the ability to mentor others. * Ability to identify problems and develop solutions. * Demonstrated ability to successfully manage multiple projects. Additional Job Details (if applicable) Remote Type Onsite Work Location 350 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Clinical Research Assistant Needed The role involves monitoring participants using various technology products, collecting data, and ensuring the proper functioning of devices and data collection throughout the study sessions. Great opportunity to gain experience in clinical research! Schedule: * Monday - Friday * 7:30am-3:00pm or 2:00pm-9:00pm *can be flexible* Responsibilities * Consent participants according to protocol and take necessary vitals and measurements (height, weight, EKG) throughout the session. * Ensure participants are properly set up with devices and any monitoring equipment. * Operate several pieces of instrumentation and observe participants using devices during various activities as per protocol. * Ensure data monitoring is functioning properly throughout the session and ensure proper data collection. * Guide participants through the study and support data collection directly. Required Skills * Experience in research and data entry. * Bachelor's Degree in science, exercise science, kinesiology, or biology. * Technical proficiency to operate test devices and perform data entry. * Ability to direct participants through the study, with examples of patient care or people interaction. "Nice to have" Qualifications * Experience in human subject research and data analysis. * Familiarity with gym equipment and clinical research. Pay and Benefits The pay range for this position is $25.00 - $25.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Natick,MA. Application Deadline This position is anticipated to close on Apr 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Clinic Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Any other matters, as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is preferred

Department Operations Employment Type Full Time Location Boston Clinical Trials | Roslindale, MA Workplace type Onsite Reporting To Joanne Monaghan Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. Our Tufts Alzheimer's Research Program (TARP) conducts innovative, multidisciplinary research focused on improving the lives of individuals living with Alzheimer's disease and related dementias. Our research portfolio spans federally funded (NIH) grants, foundation-supported initiatives, and industry-sponsored clinical trials, reflecting a robust and collaborative approach to advancing the field. Integrated within the Tufts Medicine Memory Care Center, our team bridges clinical care and research to accelerate the development and evaluation of novel therapeutics. Our studies explore a range of topics including the behavioral and psychological symptoms of dementia, disease-modifying therapies, and emerging interventions aimed at enhancing cognitive, emotional, and functional outcomes for patients and their caregivers. We also study the implementation of dementia care pathways and models of care aimed at streamlining screening, assessment, diagnosis and referral to treatment within primary care medical settings. Job Profile Summary 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. 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. 3. Two (2) years in research related activities. Preferred Qualifications: 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. Care in organization and systematic record-keeping 7. Previous experience in clinical trials desirable 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. Responsible for assisting in the recruitment of study participants. 2. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required. 3. Completes follow up with study participants in prescribed settings as required. 4. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. 5. Complies with all institutional policies and government regulations pertaining to human subjects' protections. 6. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews. 7. Performs basic laboratory activities as needed. 8. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. 9. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor. 10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. 11. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc. 12. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation. 13. Maintains inventory of all study supplies. 14. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. 15. Reviews all eligibility and ineligibility criteria in the patient's record. 16. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form. 17. Conducts a QC check of completed CRFs prior to submission for data entry. 18. Coordinates resolution of all data queries. 19. Completes data entry as warranted. 20. Maintains regulatory binders, case report forms, source documents, and other study documents. 21. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board. 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: $47,924.24 - $59,894.75

About the BSO Founded in 1881, the Boston Symphony Orchestra (BSO) is one of the premier orchestras in the world. The BSO is committed to bringing world class music and performances to the local and international communities. The key to our success has been our employees from the musicians onstage to those behind the scenes. About the Role The Donor Acknowledgment and Research Coordinator plays a dual role within the Boston Symphony Orchestra's Development Office, with responsibilities evenly divided between donor acknowledgment and prospect research. Donor Acknowledgment (50%): As a member of the Development Operations team, the Coordinator ensures the accurate and timely processing of tax receipts and donor acknowledgment correspondence, helping to properly recognize and thank donors for their contributions. Prospect Research (50%): In collaboration with the Senior Director of Prospect Strategy and Development, the Coordinator conducts research and evaluates donor giving capacities to strengthen fundraising efforts. This portion of the role involves a dotted-line reporting relationship to the Senior Director. This position provides a unique opportunity to gain broad exposure to both donor stewardship and fundraising research within a major performing arts organization. The role officially reports to the Associate Director of Development Information Systems, with a dotted-line reporting relationship to the Senior Director of Prospect Strategy and Development. Job Responsibilities Donor Acknowledgement: Following an established timetable and protocol, manages weekly gift acknowledgment system, including generating, editing, and tracking IRS required tax receipts and acknowledgment letters for various brands, purposes, and signers. On occasion, and in collaboration with other members of the organization, writes highly personalized correspondences to high-level donors to recognize and communicate the impact of their contributions to the BSO. Requires cross-department collaboration to ensure these letters are signed, scanned, and mailed. Develops a thorough knowledge of constituent records, data reports, list building, and acknowledgment rules in Tessitura, the relational database software system utilized by the BSO. Collaborates with the Development Communications team to regularly update and refresh standard acknowledgment text as well as facilitate weekly acknowledgment emails. Assists with other daily data and gift processing and reconciling activities as directed and provides support for other projects as assigned by the Assistant Director of Development Information Systems and/or senior management in the department. Prospect Research: Conducts biographical and financial research on individual, corporate and foundation donors and prospects for the BSO, Pops, and Tanglewood Assists with the creation of event bios for galas to small donor and prospect gatherings Conducts weekly screenings of new Society level donors for potential gift officer assignment Manages the annual subscriptions and contracts for various research resources and the research budget, and monitors the research request email in-box and tracker Enters donor and prospect information into Tessitura, including the most current event bios and data uncovered through research Working closely with other members of the Research team, help with multiple research requests and prospect identification projects Required Education and Experience Qualifications One to three years of experience writing in a professional environment with exceptional ability to write and edit clearly, accurately, and concisely. Exhibit strong attention to detail and accuracy in both the recording and outputting of donor information. Strong proficiency with Microsoft Office, including experience working with Excel, mail merges, and correspondence standards. Proven proficiency in complex document output from a data-based software; experience in Tessitura a plus. Demonstrated ability to exercise good judgment and diplomacy and maintain highly confidential information. Ability to work independently, as well as collaboratively within a dynamic, sophisticated organization. Interest in and knowledge of the non-profit environment, particularly the arts, preferred. Bachelor's degree. Pay Rate Range: $20.87 - $24.81 The BSO is an equal opportunity employer deeply committed to equity, diversity, and inclusion (EDI). As such, the BSO does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status or any other basis protected by applicable federal, state or local law, as well as our own insti tutional EDI values.

As a member of the clinical research team, the Clinical Research Coordinator I responsibilities will be associated with one or more clinical research project(s). In this role, you will work directly with patients with or without diabetes and chronic kidney disease and will assist with assigned study/studies. As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. We require that all staff be vaccinated against influenza (flu) as a condition of employment. Responsibilities Provides support on clinical research protocols. Recruits, schedules and interviews patients, performs routine laboratory procedures (including, measuring blood pressure, height and weight, and/or phlebotomy if certified) and protocol, and escorts patients to testing locations. Coordinates patient recruitment to ensure the enrollment goals are met for multiple grants or industry sponsored clinical Facilitates patient visits by performing protocol specific tests and procedures. Assists with developing, maintaining and completing study data collection forms and source documents. Maintains research patient records and regulatory binders. Performs data entry. Organizes the storage and use of the study related materials. Participates in the labeling, organization, storage and retrieval and storage of study biospecimens. Coordinates with Laboratory Cores for sample analysis. Processes laboratory samples and deliver samples to local laboratory or mails to central laboratory. Participates in the preparation of scientific publications and presentations of study scientific data. Assists in training new team members in all clinical research protocols, including how to properly process and store samples. Assists in keeping regulatory information up to date for the Joslin Internal Review Board (IRB) and the Committee on Human Studies (CHS). Performs general laboratory support, including ordering supplies and equipment for all studies, and performing literature searches. Activities for the studies will be performed at Joslin Diabetes Center and other facilities as required. Will closely work with the staff involved in the study in and outside of Joslin Diabetes Center and under the supervision of the PI. Participates in research team meetings including travel to Face to face steering committee meetings and study investigator meetings a few times a year. Other duties as assigned. Qualifications Bachelor's degree in the Biological Sciences/Chemistry or related science is required Previous research experience involving human subjects or clinical research preferred Fluent in written and spoken English (additionally in Spanish is preferable) Skilled user of Microsoft Office Suite Ability to follow general instructions and procedures, as provided. Strong interpersonal, organizational and communication skills (communicate clearly and effectively via verbal and written instruction). Meticulous attention to detail Professional and warm in demeanor, especially when relating to study participants and their families Ability to maintain confidentiality Ability to prioritize responsibilities - through completion. Ability to work independently and with others in the team - to interact respectfully with other employees, professional staff and/or external contacts. Excellent critical thinking and problem-solving abilities Ability to learn sophisticated concepts and detailed protocols quickly The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law. (Min) USD $21.64/Hr. (Max) USD $24.37/Hr.

About the Opportunity The Sr Research Compliance Specialist supports the functions of the central NU-RES Finance office within Northeastern University Research Enterprise Services (NU-RES) by assisting with the oversight of financial operations for the research portfolio. Reporting to the Director of Research Finance, the Sr Research Compliance Specialist will oversee and monitor aspects of the post-award lifecycle that are specific to personnel costs on sponsored projects, including effort reporting, payroll certifications, labor cost transfers, summer salary compensation, University audits, and internal reviews. This position will supervise a Compliance Specialist and serve as a central resource for the research community to ensure salary expenditures meet institutional and sponsor requirements. The Sr Research Compliance Specialist will also participate in the development of policies, procedures, and training sessions on behalf of NU-RES Finance. This position requires post-award knowledge of Uniform Guidance cost principles, federal salary caps, and effort reporting requirements. This role must treat effective compliance as an equal priority, stay abreast of sponsor rules, regulations, and policy changes, as well as institutional best practices in research administration and finance. MINIMUM QUALIFICATIONS * BS/BA in a related field is required * 5 years research administration experience required * Excellent written and verbal communication skills required, with the ability to interact with management and senior leadership * Knowledge of Uniform Guidance cost principles, federal salary caps, and effort reporting requirements * Ability to thrive in a fast-paced operations group, prioritize duties, and meet deadlines * Must be able to work effectively both independently and in a collaborative environment * Proficient in Microsoft Office programs such as Teams, Excel, PowerPoint, Word, Sharepoint, Outlook, and other analytical tools and workflows * Proven customer service skills and keen organizational skills * This position requires that you have an active DoD Secret clearance (or other necessary level) or ability to obtain clearance at the Secret level. JOB DUTIES The Sr Research Compliance Specialist's main responsibilities include reviewing incoming payroll transactions in Workday. This includes confirming expenditures are in line with the sponsor approved budget, that they meet effort requirements, and follow Institutional Base Salary rates and federally mandated salary caps. The Sr Research Compliance Specialist will work with Department Administrators to ensure prior approval requests and compensation requests are coordinated with NU-RES and Payroll teams as necessary. Workday Compliance Reviews (40%) * Grant-funded Position Reqs * Costing Allocations * Payroll Accounting Adjustments (Cost Transfers) * Period Activity Pay (Summer Salary) * One-Time Payments Policies, Standard Operating Procedures & Trainings (25%) * Develop and maintain policies to ensure compliance with federal regulations and organizational policies in collaboration with subject matter experts, key stakeholders and compliance offices * Develop procedures related to research payroll, create documents for various internal and external users and facilitate roll out and implementation. * Lead training sessions, workshops, and other learning opportunities for NU-RES staff and research community to establish consistency in practice. Audits & Metrics (20%) * Support all internal/external audits, site visits, and desk reviews. Ensure proper documentation is collected and submitted appropriately. * Monitor payroll outside of period of performance to assist with closeout process. * Work in collaboration with the Process and Audit Manager on all audits, assessments and desk reviews * Distribute metrics reports to NU-RES Finance leadership. Research Payroll Certification (15%) * Distribute and collect Research Payroll Certifications. Manage certification process to completion and ensure late certs are addressed/resolved in a timely manner. Position Type Research Additional Information Northeastern University considers factors such as candidate work experience, education and skills when extending an offer. Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit ************************************* for more information. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law. Compensation Grade/Pay Type: 111S Expected Hiring Range: $86,490.00 - $122,163.75 With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role. Salary ranges are reviewed regularly and are subject to change.

ICON is seeking Senior Global Clinical Trial Manager for the Waltham, MA office. Pay up to $170k (No bonus) As the Senior Global Clinical Trial Manager, will be responsible for Running global clinical trials, trial deliverable, trial budget, trial vendors, CRA and Site operational oversite and training. Following monitoring plans and reviewing trip reports. This position will be, direct hire with full benefits, 3 days in the office (900 Winter St, Waltham, MA 02451) with 2 days remote from home, with pay up to $170k (No bonus) Please let me know if you are interested in finding out more about this opportunity? Senior Global Clinical Trial Manager (ICON embedded with Alkermes) What you will be doing: Clinical Trial Management with, deliverable, budget, vendor management, along with vendor and site oversite and training. Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation. Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight. Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance. Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines. Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary. Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Your profile: Currently, or recently, working at a CRO, Pharmaceutical or Biotechnology company. A minimum of 4+ years of experience in a Global Clinical Trial Management position at a CRO or Pharmaceutical Organization. Clinical Trial Management experience including trial deliverable, trial budget, vendor management, along with vendor and site oversite and training. Experience as a Clinical Trial Manager running Phase 1 trials Bachelor's degree in health, life sciences, or other relevant fields of study. At least 10+ years of relevant clinical experience Preferred: 2+ years of monitoring experience. Experience in managing complex or global trials is advantageous. Experience in managing trial components from start-up to database lock. Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives.

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. Job Summary The MGH CORE Program is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our multidisciplinary team. This position offers the opportunity to take on a leadership role in advancing innovative supportive care research in oncology and palliative care. The MGH CORE Program brings together oncologists, palliative care specialists, psychiatrists, psychologists, nurses, and other allied clinician researchers dedicated to improving the quality of care and outcomes for patients and families facing cancer and serious illness. Senior Clinical Research Coordinator (CRC) The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities. Qualifications Key ResponsibilitiesLeadership & Training Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices. Assist CORE faculty investigators with allocating workload and providing ongoing feedback. Study Coordination Provide an extra layer of support in managing CORE studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits. Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs. Regulatory & Compliance Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports. Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies. Program Development Assist in developing standard operating procedures and quality assurance systems. Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions. Qualifications Education & Experience Bachelor's degree required (health sciences, psychology, public health, nursing, or related field preferred) Minimum of 2-5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation. Skills & Competencies Ability to oversee, train and evaluate others effectively. Strong organizational, time management, and problem-solving skills. Excellent interpersonal and written/verbal communication skills. Ability to work independently and collaboratively across multiple investigators and teams. Familiarity with REDCap and other data capture systems preferred. Application Instructions Please submit your resume and a cover letter (maximum 300 words) describing your background, interest in supportive care research, and what makes you a strong candidate for this leadership role. We value team members from diverse backgrounds and encourage applicants to share in their cover letter how their unique experiences, perspectives, or interests would contribute to our program's mission. Additional Job Details (if applicable) Remote Type Onsite Work Location 125 Nashua Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 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.

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 into 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 Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact * Ability to understand and follow institutional SOPs * Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. * Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct * Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff * Assist with planning and creation of appropriate recruitment and marketing materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. * Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies * Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives * Assist in the creation or review of protocol specific source documents * Determine facility, equipment and outsource vendor requirements and availability * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance * Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks * Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. * Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies * Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records * Collect and evaluate concomitant medications * Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. * Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings * Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion * Maintain effective relationships with study participants and other Care Access personnel * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management * Strong and clear communication skills, both verbally and in writing * Accept accountability for actions and function independently * Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment * Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial * Administer delegated study questionnaires, where appropriate. * Collect and evaluate medical records with the support of medically qualified members of the study team. * Complete visit procedures and ensure proper specimen collection, processing and shipment 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 * Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) * Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol * Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround * Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. * Monitor patient progress on study medication * Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP * Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. * Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart * Accurately transcribe data to CRF or EDC. * Resolve data management queries and correct source data as needed * Record protocol exemptions and deviations as appropriate with sponsor. * Complete Note(s)-to-File for patient chart and regulatory filing if necessary * Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing * Maintain copies of patient-specific correspondence in source charts * Assist regulatory personnel with completion of continuing/final review reports * Perform other duties as assigned. The Expertise Required * Excellent working knowledge of clinical trials, medicine and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ * 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. * Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. * 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: * BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred * RN or LPN preferred * Research Professional Certification- CRCC or exam eligibility preferred * A minimum of 3 to 4 years Clinical Research experience * A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together * Location: This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide. * Travel: Duties may require travel in the following models: * Two weeks on / One week off deployments * Temporary Event Support (3-7-day deployment durations) * Weekly deployments (one week on, 2-5 days off). * Frequency and length of travel may depend on the length and location of study, site, and event. * Deployments normalize to a 32 to 42-hour work week on average. The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. 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: ********************************