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  • Clinical Research Associate

    Vivid Resourcing

    Clinical research associate job in Boston, MA

    Job Title: Clinical Research Associate (CRA) - Oncology Reports to: Director of Clinical Operations Our client is a Boston-based biotechnology company dedicated to developing innovative oncology therapies that address unmet medical needs. The team is driven by scientific rigor, patient-centricity, and collaboration to advance cutting-edge cancer treatments from early development through late-stage clinical trials. Position Summary The Clinical Research Associate (CRA) will support the planning, execution, and monitoring of oncology clinical trials in compliance with ICH-GCP, FDA regulations, and company SOPs. The CRA will serve as a key liaison between investigative sites and the clinical operations team, ensuring data integrity, patient safety, and operational excellence across assigned studies. Key Responsibilities Conduct site qualification, initiation, monitoring, and close-out visits for oncology clinical trials Ensure protocol compliance, data accuracy, informed consent integrity, and patient safety Monitor AE/SAE reporting, protocol deviations, and essential documentation Train and support site staff and maintain strong site relationships Review and maintain study documentation and Trial Master File (TMF) Track site performance, identify risks, and proactively resolve issues Collaborate cross-functionally and provide timely monitoring reports Support audit and inspection readiness Qualifications Bachelor's degree/Master's degree in Life Sciences, Nursing, or a related field (required) 2+ years of CRA experience in clinical research (oncology preferred) Experience monitoring interventional clinical trials (Phase I-III preferred) Knowledge of Good Clinical Practices (GCP), clinical monitoring, study site oversight and management. Strong knowledge of ICH-GCP and FDA regulations Excellent communication, organizational, and problem-solving skills Ability to manage multiple sites and travel up to 30% Offer Salary 100-150k (depending on level of experience) Career development opportunities in a growing oncology-focused organization Collaborative, mission-driven work environment in the Boston biotech hub
    $60k-92k yearly est. 5d ago
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  • Chief, Global Research Quality - Non-Clinical

    Takeda 4.7company rating

    Clinical research associate job in Boston, MA

    A leading biopharmaceutical company is seeking a Head of Research Quality to provide strategic oversight and leadership within their Research Quality organization. This role is crucial in defining, executing, and overseeing compliance and integrity in non-clinical research activities. The ideal candidate will have extensive experience in the biopharma sector, excellent leadership and communication skills, and a strong understanding of global regulations. This position is based in Boston, MA, offering a competitive salary range of $208,200 - $327,140, along with comprehensive benefits including medical insurance and a 401(k) plan. #J-18808-Ljbffr
    $50k-73k yearly est. 18h ago
  • Clinical Research Associate

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Clinical research associate job in Boston, MA

    Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: · Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria · Enroll patients as required by the study sponsor and internal enrollment monitor team · Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance · Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. · Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations · Maintain research charts and/or electronic files for all enrolled patients · Ensure adequate source documentation is in place for all data reported · Resolve data queries issued by the sponsor · Obtain protocol clarifications from the study sponsor and communicate information to the research team · Schedule and prepare for monitoring visits with sponsors · Organize and prepare for internal and external audits · Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols · Ability to demonstrate respect and professionalism for subjects' rights and individual needs Job Summary Summary Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. Does this position require Patient Care? No Essential Functions -Maintain and organize study-specific regulatory binders. -Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB. -Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study. -Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required. -Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process. -Collect, complete, and submit essential regulatory documents to various regulatory entities. -Participate in monitoring visits and maintain a record of all correspondence related to these visits. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Research Related Experience 1-2 years preferred Knowledge, Skills and Abilities - Attention to detail. - Ability to recognize compliance and data integrity issues and respond appropriately. - Working knowledge of clinical research protocols. - Ability to communicate effectively with patients, vendors, contract research organizations and professional staff. - Effective interpersonal and communication skills. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Hybrid Work Location 101 Merrimac Street Pay Range $20.16 - $29.01/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $20.2-29 hourly Auto-Apply 5d ago
  • Oncology Clinical Research Associate

    ZP Group 4.0company rating

    Clinical research associate job in Boston, MA

    Piper Companies is currently seeking an Oncology Clinical Research Associate (CRA) for an opportunity in Boston, Massachusetts (MA). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Oncology Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Oncology Clinical Research Associate: * 3+ years of Oncology on-site Monitoring and hands on experience with EDC Systems * Experience with Phase 1 Oncology is non-negotiable * Organization to perform monitoring duties across multiple sites is a must Compensation for the Oncology Clinical Research Associate: * Salary Range: $110,000-$135,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1
    $110k-135k yearly 1d ago
  • Clinical Research Associate

    Stratacuity

    Clinical research associate job in Acton, MA

    Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions. Apex has an opportunity for an Clinical Research Associate. For applicants who are interested in this opportunity, send your updated resume to [email protected]. Here are the details: Position: Clinical Research Associate Location: Remote Project Duration: 6 months Rate: Negotiable Bases on Experience JOB DESCRIPTION The Clinical Research Associate (Monitor) is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required. Responsibilities: * Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits and site initiation visits to ensure applicability of sites for planned study according to application regulatory requirements. * Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements. * Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent and support Institutional Review Board (IRB) submissions. * Train site staff on protocol requirements, source documentation, and case report form completion. * Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted. * Conduct clinical study site close-out visits and ensure site files are complete, accurate and up to date. * File site related documents real-time to ensure Trial Master Files are complete and accurate at all times. * Provide study specific information and support report validation activities as requested for clinical study reports. * Participates in team meetings and document meeting minutes and tracks action items. * Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines. * Performs other duties as required (note, all listed tasks may not be conducted depending on study status and roles of other internal and external team members). Education and Experience: * B.S. or B.A. and/or an equivalent combination of education or experience. * Minimum of 3 years of experience directly related to the execution of clinical research studies. * Available to travel (up to 60%) on short notice and independently manage travel schedules. * Must have analytical skills, be detail oriented and have good interpersonal skills. * Knowledge of agency guidelines and requirements. Skills/Competencies: * Effective written and verbal communication skills. * Ability to communicate at all levels of an organization. * PC skills; word processing, spreadsheet, database, Internet search and utilization. * Flexible and able to work in a fast-paced environment. * Team player. * Ability to organize and judge priorities. * Excellent ability to generate and maintain accurate records. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide. Employee Type: Contract Remote: Yes Location: Acton, MA, US Job Type: Scientific and Clinical Date Posted: January 29, 2026 Pay Range: $55 - $65 per hour Similar Jobs * Clinical Trial Contracts Associate I * UX Researcher * Director of Clinical Solutions * Research Chemist Technician * User Experience Researcher
    $55-65 hourly 1d ago
  • Clinical Research Associate

    Integrated Resources 4.5company rating

    Clinical research associate job in Lexington, MA

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description · The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s). · The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. · The CRA performs work within established protocols under general supervision. · Assists the study team(s) to deliver the clinical study within agreed timelines. · Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.) Provides oversight of Clinical CRO Investigator background checks. · Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary. · Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP. · Reviews Clinical Monitoring Reports and correspondence related to restudy and Initiation Visits and follows up with Clinical CRO to resolve open action items. · Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager. · Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System. · Assists and/or participates in planning and conduct of Investigator's Meetings as necessary. · Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced. · Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager. · Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present. · Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements. · Assists study team with preparation for audits/inspections Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager. · Liaises with Transparency group to ensure Clintrials.gov is updated. Additional Information Feel free to forward my email to your friends/colleagues who might be available. Thanks, Warm Regards, Kavita Kumari Integrated Resources, Inc. Direct: (732) - 844 8725
    $57k-84k yearly est. 60d+ ago
  • Clinical Research Associate

    Alira Health 4.4company rating

    Clinical research associate job in Framingham, MA

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary Job Description ROLE The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIES Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Conducts investigational product accountability. Reviews regulatory binder for required documents. Works closely with in-house CRAs and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Manages and resolves conflicting priorities to deliver on commitments. Complies with ICH GCP guidelines, FDA regulations, and company SOPs. Participates in industry and client meetings. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE BS/BA from an undergraduate program or equivalent experience 2 years of clinical research experience TECHNICAL COMPETENCES & SOFT SKILLS Ability to travel. Proven ability to be careful, thorough, and detail-oriented. Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. Self-starter who thrives in a collaborative, yet less structured team environment Ability to problem-solve unstructured or ambiguous challenges. Strong command of English, both written and verbal. Excellent communication and interpersonal skills with customer service orientation. Proficient with MS Office Suite, particularly Word and Excel. Permanent authorization to work in the country where you are applying. Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular
    $61k-97k yearly est. Auto-Apply 60d+ ago
  • Associate Director - Clinical Research Scientist

    Eli Lilly and Company 4.6company rating

    Clinical research associate job in Boston, MA

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail. Responsibilities: The primary responsibilities of the Verve Associate Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions. Collaborate with pharmacokineticists and statisticians by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens. Clinical Research/Trial Execution and Support Design and oversee implementation of Phase lb and Ila/IIb clinical studies. Design and write clinical trial protocols. Participate in investigator identification and selection, in conjunction with clinical team. Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials. Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions Leads internal meetings to review topics and develop mitigation plans Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Scientific Data Dissemination/Exchange Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination and preparation of final reports. Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response. Business/ customer support Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis. Participate in patent development. Scientific & Technical Expertise and Continued Development Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule. Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects. Attend scientific symposia. Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Basic Requirements: Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Minimum of two years' experience in clinical development Additional Skills/Preferences: 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following: Minimum 2 of which is in clinical development Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices. Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution. Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making. Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders. Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings. Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs). Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus. Ability to travel to clinical sites, conferences, and regulatory meetings as needed. Fluent in English, verbal and written communication Additional Information: Travel 10-15% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $127.5k-204.6k yearly Auto-Apply 9d ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical research associate job in Boston, MA

    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
    $60k-92k yearly est. 60d+ ago
  • Clinical Research Associate - Boston/Northeast

    Icon Clinical Research

    Clinical research associate job in Boston, MA

    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
    $60k-92k yearly est. 60d+ ago
  • Clinical Research Associate - Boston/Northeast

    Ire

    Clinical research associate job in Cambridge, MA

    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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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
    $60k-92k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate

    CTTX Health

    Clinical research associate job in Cambridge, MA

    Are you passionate about clinical research and ready to make an impact on patients' lives? We're looking for a Clinical Research Associate (CRA) to join a fast-growing biotech company (confidential) that's advancing innovative therapies in neuroscience. What You'll Do: Conduct site initiation, monitoring, and close-out visits to ensure trials meet the highest quality standards. Review and verify study data for accuracy and completeness. Collaborate with site staff and cross-functional teams to solve challenges and keep trials on track. Identify and escalate any protocol deviations, safety concerns, or data issues. Requirements What We're Looking For: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus). 3+ years of CRA or site monitoring experience. Strong knowledge of ICH-GCP and FDA regulations. Excellent communication, organization, and problem-solving skills. Willingness to travel as needed (up to 50-75%). Extra Credit: Experience with CNS or rare-disease trials. Benefits Amazing benefits package starting day one!
    $60k-92k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate - Boston/Northeast

    Icon Central Laboratories

    Clinical research associate job in Cambridge, MA

    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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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
    $60k-92k yearly est. Auto-Apply 15d ago
  • Clinical Research Associate

    Global Channel Management

    Clinical research associate job in Cambridge, MA

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Clinical Research Associate needs 2-5 years of clinical research experience in industry settings with a bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field Clinical Research Associate requires; oncology experience strongly preferred EDC systems Knowledge of clinical trial methodology as well as the drug research and development process Knowledge of GCP/ICH Guidelines for clinical studies ORACLE CLINICAL TRIALS CLINICAL MONITORING Clinical Research Associate duties are: Participation in the evaluation of clinical trial site locations. Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out. Traveling to sites as necessary to conduct site qualification, initiation, and close-out ( Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements. Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety. Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements. Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials. Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies. Helping to draft study manuals and protocol amendments as needed. Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials. Coordinating the movement of laboratory samples between clinical sites and central laboratories, and tracking the status of samples and resulting laboratory data. Additional Information $31/HR 6 months
    $31 hourly 60d+ ago
  • Clinical Research Associate

    Brigham and Women's Hospital 4.6company rating

    Clinical research associate job in Boston, MA

    Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: * Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria * Enroll patients as required by the study sponsor and internal enrollment monitor team * Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance * Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. * Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations * Maintain research charts and/or electronic files for all enrolled patients * Ensure adequate source documentation is in place for all data reported * Resolve data queries issued by the sponsor * Obtain protocol clarifications from the study sponsor and communicate information to the research team * Schedule and prepare for monitoring visits with sponsors * Organize and prepare for internal and external audits * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects' rights and individual needs Job Summary Summary Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. Does this position require Patient Care? No Essential Functions * Maintain and organize study-specific regulatory binders. * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB. * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study. * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required. * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process. * Collect, complete, and submit essential regulatory documents to various regulatory entities. * Participate in monitoring visits and maintain a record of all correspondence related to these visits. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Research Related Experience 1-2 years preferred Knowledge, Skills and Abilities * Attention to detail. * Ability to recognize compliance and data integrity issues and respond appropriately. * Working knowledge of clinical research protocols. * Ability to communicate effectively with patients, vendors, contract research organizations and professional staff. * Effective interpersonal and communication skills. Additional Job Details (if applicable) Physical Requirements * Standing Frequently (34-66%) * Walking Frequently (34-66%) * Sitting Occasionally (3-33%) * Lifting Frequently (34-66%) 35lbs+ (w/assisted device) * Carrying Frequently (34-66%) 20lbs - 35lbs * Pushing Occasionally (3-33%) * Pulling Occasionally (3-33%) * Climbing Rarely (Less than 2%) * Balancing Frequently (34-66%) * Stooping Occasionally (3-33%) * Kneeling Occasionally (3-33%) * Crouching Occasionally (3-33%) * Crawling Rarely (Less than 2%) * Reaching Frequently (34-66%) * Gross Manipulation (Handling) Frequently (34-66%) * Fine Manipulation (Fingering) Frequently (34-66%) * Feeling Constantly (67-100%) * Foot Use Rarely (Less than 2%) * Vision - Far Constantly (67-100%) * Vision - Near Constantly (67-100%) * Talking Constantly (67-100%) * Hearing Constantly (67-100%) Remote Type Hybrid Work Location 101 Merrimac Street Pay Range $20.16 - $29.01/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $20.2-29 hourly Auto-Apply 5d ago
  • Clinical Trial Coordinator

    Mindlance 4.6company rating

    Clinical research associate job in Lexington, MA

    • Requires Bachelors degree from accredited US College or University can NOT be remote, no relocation • This is a 6 month contract - may be extended but not guaranteed • Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) • Experience with finances, accounting or invoicing a plus Qualifications • Requires Bachelors degree from accredited US College or University Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) Additional Information All your information will be kept confidential according to EEO guidelines.
    $56k-79k yearly est. 2d ago
  • Clinical Research Coordinator-CV

    Southcoast Health System 4.2company rating

    Clinical research associate job in Fall River, MA

    Community Focused. Care Driven. Join Southcoast Health, where your future is as promising as the care we provide. Our commitment to each other, our patients, and our community is more than a mission - it's our way of life, and you'll be at the heart of it. Southcoast Health is a not-for-profit, charitable, health system with multiple hospitals, clinics and facilities throughout Southeastern Massachusetts and Rhode Island. Nestled in local communities, Southcoast Health provides inclusive, ethical workplaces where our highly skilled caregivers offer world-class, comprehensive healthcare close to home. Find out for yourself why Southcoast Health has been voted 'Best Place to Work' for 7 years in a row! We are searching for a talented Clinical Research Coordinator-CV This is an onsite role A career at Southcoast Health offers you: * A culture of well-being that embraces, respects, and celebrates the rich diversity of one another and the communities we serve * Competitive pay and comprehensive benefits package * Generous Earned Time Off Package * Employee Wellbeing Program * 403B Retirement Plan with company match * Tuition assistance / Federal Loan Forgiveness programs * Professional growth opportunities and customized leadership training Available to regular status employees who are scheduled to work a minimum of 24 hours. Southcoast Health is an Equal Opportunity Employer. Responsibilities Under the direction of the Care Center Director or Designee, perform diversified duties in coordinating all activities related to clinical trials. Duties include but are not limited to oversight of all research-related activities, screening and evaluation of prospective trial patients, clinical follow-up of enrolled trial patients, correspondence and coordination with the Institutional Review Board and trial sponsors. Facilitation and development of relationships with Sponsors for clinical trials. Management/tracking of compliance with Federal and institution guidelines relating to conducting human subject research. Educate patients to clinical trials and obtain informed consent to participate. Responsible for implementing new trials, collaborating with multiple MD Principal Investigators, negotiating and maintaining budgets, managing audits and ensuring adherence to study protocols about mandated visits, medicine management and symptom tracking. Qualifications * Bachelors Degree or the equivalent experience is required. * Degree in Healthcare administration, Healthcare, Science or related field is preferred. * Three to five years of experience working directly in clinical trials involving human subjects is preferred. * Attention to detail and strong organizational skills are required. * US Drivers license is required. * Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) is preferred. * Certification within 6 months of hire. * If less than 2 years full time clinical research experience, the minimum allowed before you can sit for the exam, certification will then be required. * Must be fully vaccinated against seasonal Influenza and the COVID 19 virus or to be exempt from the requirement for medical or personal reasons by signing a statement certifying you are choosing to be exempt from vaccination once hired Compensation: Pay rate will be determined based on level of experience. Pay Range USD $57,553.60 - USD $96,761.60 /Yr. Rotation Schedule Requirement M-F
    $57.6k-96.8k yearly Auto-Apply 25d ago
  • Clinical Research Coordinator II (Stroke/Neurology)

    Mass General Brigham

    Clinical research associate job in Boston, MA

    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 Summary Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Additionally, it provides input into determining study subject suitability and input into recruitment strategy. Performs data analysis, interpretation, QA/QC, and assists in completing reports and presentations. Does this position require Patient Care? No Essential Functions -Assists with determining the suitability of study subjects and acts as a resource for patients and families. -Has input into recruitment strategies and may contribute to protocol recommendations. -Administers scores and evaluates study questionnaires. -Maintains research data, patient files, regulatory binders, and study databases. -Performs data analysis and QA/QC checks and organizes and interprets data. -Assists with preparation for annual review and assists PI in completing study reports and presentations. -May assist with training and orientation of new staff members. Qualifications Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Related post-bachelor's degree research experience 1-2 years required Knowledge, Skills and Abilities - Ability to work more independently and as a team member. - Computer literacy, analytical skills, and ability to resolve technical problems. - Ability to interpret the acceptability of data results. - Working knowledge of data management programs. Additional Job Details (if applicable) The Massachusetts General Hospital Stroke and Neurocritical Care Research Center is one of the largest and most prolific stroke research centers in the country employing a diverse team of clinical researchers managing novel clinical trials in stroke and vascular diseases. The Center's staffing structure and project portfolio support professional growth of clinical research staff at all levels as well as successful facilitation of highly complex interventional trials and large-scale genetic, longitudinal and observational studies. The Clinical Research Coordinator II will work with a dynamic team of investigators, coordinators and fellows to coordinate multiple inpatient and outpatient neurologic studies involving patients from diverse clinical settings, including, but not limited to, the emergency department, neurosurgery, neurointensive care unit, and ambulatory stroke clinics. They will be responsible for the day-to-day coordination of assigned longitudinal, observational and/or interventional clinical research studies including patient-facing recruitment/enrollment activities and facilitation of study-specific administrative and regulatory activities. Remote Type Onsite Work Location 175 Cambridge Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $23.80 - $34.81/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $23.8-34.8 hourly Auto-Apply 36d ago
  • Clinical Research Accounting Coordinator

    Dana-Farber Cancer Institute 4.6company rating

    Clinical research associate job in Brookline, MA

    This is Part-Time; 24 hours/week role Under direct supervision of the Senior Clinical Research Accounts Specialist, the Clinical Research Accounting Coordinator is responsible for accounts creation and accounts receivable of financial transactions generated from Dana-Farber Cancer Institute Clinical Research activity. Handles basic issues and problems and refers more complex issues to higher -level staff. In the absence of a Senior Clinical Research Accounts Specialist this position is under direct supervision of the Clinical Research Accounting Manager. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. **Primary Duties and Responsibilities:** + Submits study financial account creation requests for each new Clinical Research contract budget in a timely manner, as necessary. + Maintains master list of study account numbers with applicable study IRB numbers for tracking and reporting purpose. + Maintains an updated list of payment contacts for all studies and funding sources, as applicable. + Monitors study payment activity and consistently pursues collections from extramural research sponsors and funding sources on all open accounts receivables to ensure timely payments. + Tracks, documents, and reports payment collection follow up with study funding sources while maintaining accurate and organized accounts receivable files. + Organizes and maintains the Clinical Research Accounting central e-mailbox; Responds to study accounts receivable and payment status inquiries via e-mail communications. + Receives Clinical Research checks and wire payments; identifies and enters payments received to the correct study record in the Clinical Trial Management System (CTMS); Stores copies of all payments received for financial reconciliation purpose; submits payments to Finance for study account deposit. + Prepares accounts receivable and other financial reports, forecasts, and analyses, as instructed. + Handles basic issues and problems and refers more complex issues to higher level Clinical Research Accounting team members; escalates invoice revision and justification requests to the applicable Clinical Research Accounting Specialist. **Knowledge, Skills and Abilities:** + Effective oral and written communication skills. + Good listening skills. + Ability to perform basic math and accounting skills + Strong organization skills and attention to detail. + Proficiency in data entry and Microsoft Office Suite (especially Excel) + Ability to analyze and interpret financial data accurately **Minimum Job Qualifications:** + High school diploma required + Bachelor's degree in accounting or finance preferred + No experience required + Working knowledge of the clinical trials lifecycle preferred **License/Certification/Registration Required:** MCA Certification within 1-year of hire **Supervisory Responsibilities:** None **Patient Contact:** No At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. **EEO Poster** . Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA). $50,800.00 - $59,400.00
    $50.8k-59.4k yearly 30d ago
  • Clinical Research Coordinator

    Alcanza Clinical Research

    Clinical research associate job in Boston, MA

    Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, SC, TX, VA, and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. Key Responsibilities Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to: * Screening of patients for study enrollment; * Patient consents; * Patient follow-up visits; * Documenting in source clinic charts; * Entering data in EDC and answers queries; * Obtaining vital signs and ECGs; * May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; * Requesting and tracking medical record requests; * Updating and maintaining logs, chart filings; * Maintaining & ordering study specific supplies;] * Scheduling subjects for study visits and conducts appointment reminders; * Building/updating source as needed; * Conducting monitoring visits and resolves issues as needed in a timely manner; * Ensuring study related reports and patient results are reviewed by investigator in a timely manner; * Filing SAE/Deviation reports to Sponsor and IRB as needed; * Documenting and reporting adverse events; * Reporting non-compliance to appropriate staff in timely manner; * Maintaining positive and effective communication with clients and team members; * Always practicing ALCOAC principles with all documentation; * May assist with study recruitment, patient enrollment, and tracking as needed; * Maintaining confidentiality of patients, customers and company information, and; * Performing all other duties as requested or assigned. * Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; * Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed; * May set up, train and maintain all technology needed for studies. Skills, Knowledge and Expertise Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: * Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm); * Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc * Strong organizational skills and attention to detail. * Well-developed written and verbal communication skills. * Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. * Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities. * Must be professional, respectful of others, self-motivated, and have a strong work ethic. * Must possess a high degree of integrity and dependability. * Ability to work under minimal supervision, identify problems and implement solutions. * Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits * Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. * Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
    $45k-66k yearly est. 27d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Quincy, MA?

The average clinical research associate in Quincy, MA earns between $49,000 and $112,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Quincy, MA

$75,000

What are the biggest employers of Clinical Research Associates in Quincy, MA?

The biggest employers of Clinical Research Associates in Quincy, MA are:
  1. Brigham and Women's Hospital
  2. CTTX Health
  3. ZP Group
  4. Massachusetts Eye and Ear
  5. Oracle
  6. Allen Spolden
  7. Global Channel Management
  8. Icon Central Laboratories
  9. Icon Clinical Research
  10. Ire
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