Clinical research coordinator jobs in Cranston, RI

**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.

The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development at Alkermes. He/She will lead operations across all future clinical sites to ensure operational and the organization's objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance. Role and Responsibilities Responsible for developing strategy, and methodology of clinical operations programs. Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready. Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals. Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines. Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers). Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols. Responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable. Drive site selection and subject recruitment programs to deliver study enrollment targets. Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors. Participates in SOP development, process mapping, training of CTAs, and other departmental activities. Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs Minimum Education & Experience Requirements: M.S or Ph.D in basic sciences with 10+ years' experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO. Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience leading global trials outside the US/UE/ASIA/Americas is preferred. Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management. Demonstrated experience in successful planning and implementation of clinical trial operations. Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. Required / Desired 5+ years of experience in clinical trials

Clinical Trial Manager - Phase 1 Studies Contract Role Our client's Early Clinical Stage Development team is seeking an experienced Clinical Trial Manager (CTM) to lead Phase 1 clinical trial operations. This role plays a central part in advancing early-stage clinical programs and ensuring high-quality, inspection-ready execution across all clinical sites. The CTM will provide end-to-end operational leadership, including strategy development, trial planning, vendor oversight, budget management, and proactive risk mitigation to ensure on-time, compliant delivery of Phase 1 studies. Key Responsibilities Develop and implement strategy, methodology, and operational plans for clinical programs. Ensure all clinical trials are conducted in full compliance with regulatory requirements and are consistently inspection-ready. Lead the planning, oversight, and execution of Phase 1 studies-from Start of Development through Proof of Clinical Concept. Manage trial budgets, timelines, and operational deliverables in accordance with ICH-GCP and applicable global regulations. Provide operational and strategic input on training materials, program standards, clinical development plans, and regulatory documents (e.g., Investigator Brochure, CSR, safety updates, briefing books, submission content). Drive execution excellence and contribute to trial protocols, asset evidence plans, and other development documents. Collaborate with the Clinical Trial Supply Unit to determine comparator sourcing strategies as needed. Lead site selection, startup activities, and recruitment strategies to meet enrollment goals. Participate in database setup, UAT testing, and development of monitoring guidelines, edit checks, and data cleaning workflows. Support departmental activities including SOP development, process mapping, and training of Clinical Trial Assistants. Serve as a key liaison with global cross-functional stakeholders including project management, regulatory affairs, and technical function leads. Minimum Qualifications M.S. or Ph.D. in a scientific discipline with 10+ years of Clinical Operations experience in biotech, pharma, or CRO environments. Strong ability to identify and champion process improvements focused on efficiency, reliability, cost, and quality. In-depth knowledge of FDA/EMEA regulations, ICH guidelines, and GCP requirements. Experience leading global clinical trials; international trial oversight experience preferred. Advanced expertise in patient recruitment, compliance management, safety oversight, document control, investigational product management, and budget administration. Demonstrated success in planning and executing clinical trial operations across all phases. Experience developing protocols, SOPs, CSRs, and regulatory-supporting documentation for NDAs. Proven track record of driving business process transformation and leading cross-functional teams toward complex deliverables.

. You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio. KEY RESPONSIBILITIES Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. Responsible for scientific oversight, data integrity and quality of the clinical trial(s). Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate. Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders. In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s). Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure. MINIMUM QUALIFICATIONS PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance Experience working on large data sets Proficiency with Microsoft Office and relevant scientific software Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery Experience leveraging a variety of communication tools and techniques to communicate results Experience solving problems collaboratively and handling conflict constructively Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations Experience working proactively and independently, organizing tasks, time and priorities of self and others Experience building partnerships across the company to achieve the needs of the program PREFERRED QUALIFICATIONS Experience in Hematology Oncology COMPETENCIES FOR SUCCESS Demonstrates passion for helping patients with cancer and for the science of oncology Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies Demonstrates foresight and judgment to make complex decisions Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

6-12 Month Project - Hybrid in Boston / 4x per week as needed with patients $30/HR W2 Clinical Research Coordinator (CRC) will perform research activities using approved techniques. The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases and more. Hybrid schedule however will be on site for a majority of the work with research participants Responsibilities Evaluating and tracking the eligibility of all patients seen in the clinic. Obtaining informed consent and registering patients to cohort studies and other protocols. Reviewing and abstracting the medical records for patient Entering information into the appropriate EMR and eCRF systems Maintaining on-going communications with research managers and PIs for data collection needs Qualifications Bachelor's Degree require 2+ years of experience in a research setting performing similar project responsibilities

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.

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

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. 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 The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Job Description 2+ years oncology monitoring is a requirement for this position.KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Participates in internal, client/sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Participates in internal, client/sponsor, scientific, and other meetings as required. Assists in CRA new hire training and onboarding. Performs CRA mentoring. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Manages and resolves conflicting priorities to deliver on commitments. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; 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 Able to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve unstructured or ambiguous challenges Strong command of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

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

Job Description 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!

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

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

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 General Summary/Overview Statement: The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management. Principal Duties and Responsibilities: Management responsibilities will include the following: Provide first-line supervision to a minimum of 4-6 FTEs and/or assist with specialized management projects of equivalent responsibility. Facilitate new hire, correction action, and performance evaluation process for research staff Train new staff and assess continuing education needs Assist staff with task prioritization for project assignments by meeting regularly and maintaining meeting documentation Manage staff productivity and quality of work produced by assessing work effort on individual studies Work with sponsors to resolve monitoring issues Management responsibilities may include the following: Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance Assist with pre-activation activities including pre-site qualification visits, SIVs, and facility tours Assist investigators with the completion of the New Protocol Intake Sheet for regulatory routing Proctor meetings, supply meeting materials and develop group-specific tools Data management responsibilities may consist of the following: Verify patient eligibility via chart abstraction and analysis of case data Collect and interpret data necessary for enrollment; register patients Implement and monitor procedures to ensure protocol compliance Manage data collection via chart abstraction and submit data in timely fashion Monitor and report adverse events as required by institutional/federal regulations Resolve data discrepancies Prepare IRB submission of protocol revisions, safety reports, annual progress reports Assess impact of new risk information on consent documents and revise appropriately Organize and attend on- and off-site Investigator meetings to establish procedures Organize and prepare for monitoring visits and both internal/external audits Skills/Abilities/Competencies Required Demonstrated time management and organization skills Strong written and verbal communication skills Knowledge of current and developing clinical research trends Sound interpersonal skills Ability to work independently and display initiative Demonstrated ability to successfully manage multiple projects Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group Potential to effectively supervise and train staff Supervisory Responsibilities Orient and train new staff and may supervise a minimum of 4-6 FTEs Working Conditions Duties will be performed in a hybrid setting Qualifications Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research Related Experience 3-5 years required and Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities - Trains, manages and mentors subordinate staff. - Assigns responsibility to subordinates. - Ability to design, prepare, deliver and evaluate clinical research programs. - Exceptional project management skills. - Effectively arranging resources and managing multiple small to large projects in a cross-functional environment. - Effective multitasking and time management skills. - Strong analytical, quantitative and communications skills. Additional Job Details (if applicable) Remote Type Hybrid Work Location 55 Fruit Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $62,004.80 - $90,750.40/Annual Grade 7 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.

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 General Summary/Overview Statement: The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management. Principal Duties and Responsibilities: Management responsibilities will include the following: Provide first-line supervision to a minimum of 4-6 FTEs and/or assist with specialized management projects of equivalent responsibility. Facilitate new hire, correction action, and performance evaluation process for research staff Train new staff and assess continuing education needs Assist staff with task prioritization for project assignments by meeting regularly and maintaining meeting documentation Manage staff productivity and quality of work produced by assessing work effort on individual studies Work with sponsors to resolve monitoring issues Management responsibilities may include the following: Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance Assist with pre-activation activities including pre-site qualification visits, SIVs, and facility tours Assist investigators with the completion of the New Protocol Intake Sheet for regulatory routing Proctor meetings, supply meeting materials and develop group-specific tools Data management responsibilities may consist of the following: Verify patient eligibility via chart abstraction and analysis of case data Collect and interpret data necessary for enrollment; register patients Implement and monitor procedures to ensure protocol compliance Manage data collection via chart abstraction and submit data in timely fashion Monitor and report adverse events as required by institutional/federal regulations Resolve data discrepancies Prepare IRB submission of protocol revisions, safety reports, annual progress reports Assess impact of new risk information on consent documents and revise appropriately Organize and attend on- and off-site Investigator meetings to establish procedures Organize and prepare for monitoring visits and both internal/external audits Skills/Abilities/Competencies Required Demonstrated time management and organization skills Strong written and verbal communication skills Knowledge of current and developing clinical research trends Sound interpersonal skills Ability to work independently and display initiative Demonstrated ability to successfully manage multiple projects Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group Potential to effectively supervise and train staff Supervisory Responsibilities Orient and train new staff and may supervise a minimum of 4-6 FTEs Working Conditions Duties will be performed in a hybrid setting Qualifications Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research Related Experience 3-5 years required and Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities * Trains, manages and mentors subordinate staff. * Assigns responsibility to subordinates. * Ability to design, prepare, deliver and evaluate clinical research programs. * Exceptional project management skills. * Effectively arranging resources and managing multiple small to large projects in a cross-functional environment. * Effective multitasking and time management skills. * Strong analytical, quantitative and communications skills. Additional Job Details (if applicable) Remote Type Hybrid Work Location 55 Fruit Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $62,004.80 - $90,750.40/Annual Grade 7 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.

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

Dana-Farber Cancer Institute (DFCI) is seeking a highly motivated Pre-Clinical Scientist to support the research activities at the Experimental Therapeutics (ETx) Core and the Lurie Family Imaging Center (LFIC). The ETx Core and LFIC are co-located in a state-of-the-art 14,000 square-foot preclinical facility, fully equipped with housing and procedure rooms, as well as a suite of in vivo imaging scanners. The Pre-Clinical Scientist will integrate with a highly skilled team of Scientists and Research Associates, and report directly to the Director. The in vivo studies conducted at the facility are focused on cancer research, with an emphasis on in vivo pharmacology, the assessment of novel cancer therapeutics, and multimodality imaging of cancer, and provide key information for the improvement of cancer patient treatment and care. The position is at 27 Dry Dock Ave, South Boston ****************************** Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Responsibilities The successful candidate will work collaboratively and in concert with a staff of dedicated scientists, animal/imaging technologists/associates, administrative personnel, and clinical counterparts to design and execute oncology related mouse studies using various imaging modalities (BLI/MRI/SPECT/PET/CT, etc) as well as the entire spectrum of conventional (e.g., caliper measurements, clinical scoring) endpoints to evaluate pre-clinical novel cancer therapies. The Pre-Clinical Scientist will work closely with the Director to execute the vision and strategic direction of translational cancer research. The Pre-Clinical Scientist will partner with clinical affiliates to facilitate bidirectional translational cancer science. The Pre-Clinical Scientist will work closely with other Centers and Departments at Dana-Farber that are engaged in research on small animal modeling in cancer and in experimental therapeutics. The Scientist will be expected to develop research projects for presentation at national meetings and publication in peer-reviewed journals. The Pre-Clinical Scientist will build collaborations with principal investigators, other departments, and industrial partners to design experimental therapeutics studies, and will be responsible for the execution, analysis and generation of reports for studies. Skills and Abilities Required * Hands-on experience using various cell line and PDX mouse/rat models and orthotopic models to execute in vivo workflows is highly desired. * Familiar with IVIS, PET/CT, MRI and other imaging approaches. * Demonstrated ability to deploy novel in vivo models to enable drug discovery and translational research. * Excellent interpersonal and communication skills with the ability to interact effectively with internal and external collaborators. * Demonstrated expertise in various in vitro methodologies such as immune profiling by flow cytometry, ELISA and Western blot analysis. * Ability to establish independent research and secure external funding * Full-time, M-F; hours may vary with project needs Dana-Farber Cancer Institute supports a robust Scientist career track with multiple opportunities for advancement, leadership, and recognition. The successful candidate will be appointed to a level within the Scientist career track commensurate with his or her accomplishments and abilities. Promotion on this track will be based on achievement of goals. Qualifications * PhD cancer biology, biology or relevant biological sciences * Minimum of 5 years' experience in pre-clinical pharmacology pre- or post-PhD * Established track record of research publications, preferably in cancer research * Builds productive internal/external working relationships. * Having wide-ranging experience, uses technical concepts and Institute objectives to resolve complex issues in creative and effective ways. * Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. * Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. * Networks with key contacts outside our own area of expertise. 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) $80,000 - $82,900 At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. EEOC Poster

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.

You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our Late-Stage Oncology portfolio. KEY RESPONSIBILITIES Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. Responsible for scientific oversight, data integrity and quality of the clinical trial(s). Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate. Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders. In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s). Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure. MINIMUM QUALIFICATIONS PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 2 - 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance Experience working on large data sets Proficiency with Microsoft Office and relevant scientific software Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery Experience leveraging a variety of communication tools and techniques to communicate results Experience solving problems collaboratively and handling conflict constructively Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations Experience working proactively and independently, organizing tasks, time and priorities of self and others Experience building partnerships across the company to achieve the needs of the program PREFERRED QUALIFICATION Experience leading a team COMPETENCIES FOR SUCCESS Demonstrates passion for helping patients with cancer and for the science of oncology Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies Demonstrates foresight and judgment to make complex decisions Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical