209 Clinical Investigator Research Scientist jobs in Cambridge

• Lead the design and development of innovative clinical trial protocols for novel oncology agents.
• Oversee the execution and monitoring of clinical trials, ensuring adherence to scientific rigor and regulatory compliance.
• Analyze and interpret complex clinical data, contributing to comprehensive study reports and publications.
• Collaborate with cross-functional teams including R&D, regulatory affairs, medical affairs, and manufacturing.
• Manage relationships with key opinion leaders, investigators, and clinical research organizations (CROs).
• Ensure all clinical trial activities comply with Good Clinical Practice (GCP) and relevant regulatory requirements.
• Contribute to the preparation of regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Stay abreast of the latest scientific advancements and therapeutic trends in oncology.

• Ph.D. or M.D. in a relevant scientific or medical discipline.
• Minimum of 8 years of experience in clinical research within the pharmaceutical industry, with a focus on oncology.
• Proven track record of successfully designing, implementing, and managing Phase I-III clinical trials.
• In-depth knowledge of oncology, including various cancer types, treatment modalities, and biomarkers.
• Strong understanding of regulatory requirements and guidelines governing drug development.
• Excellent scientific writing and communication skills, with experience in preparing manuscripts and presentations.
• Demonstrated leadership and project management abilities.

• Lead the development of clinical trial protocols, ensuring scientific rigor, patient safety, and regulatory compliance.
• Collaborate with cross-functional teams, including medical affairs, regulatory affairs, data management, and clinical operations, to ensure successful trial execution.
• Provide scientific and medical expertise throughout the clinical trial lifecycle, from study design to final reporting.
• Analyze and interpret clinical trial data, including safety and efficacy endpoints, in collaboration with statisticians and data scientists.
• Prepare clinical study reports (CSRs), manuscripts for publication, and regulatory submission documents.
• Stay current with the latest scientific advancements, clinical trial methodologies, and regulatory guidelines in oncology.
• Present research findings at scientific conferences and engage with key opinion leaders (KOLs).
• Manage relationships with investigators, study sites, and external collaborators.
• Contribute to the development of the company's oncology pipeline strategy.
• Ensure adherence to Good Clinical Practice (GCP) and other relevant regulations.
• Provide scientific input for the development of Investigator Brochures and other study-related documents.

• Ph.D. in a relevant life science discipline (e.g., Pharmacology, Molecular Biology, Immunology) or an MD.
• Minimum of 7-10 years of experience in clinical research, with a significant focus on oncology drug development.
• Proven experience in designing, conducting, and analyzing Phase I-III clinical trials.
• In-depth knowledge of oncology, including cancer biology, therapeutic strategies, and clinical trial design principles.
• Familiarity with regulatory requirements (e.g., FDA, EMA) and ICH-GCP guidelines.
• Excellent scientific writing and presentation skills.
• Strong analytical and problem-solving abilities.
• Demonstrated ability to work collaboratively in a multidisciplinary team environment.
• Experience with data analysis software and statistical interpretation is a plus.
• Strong project management and organizational skills.

You may choose to display a cookie banner on the external site. You must specify the message in the cookie banner and may add a link to a relevant policy. If you are unfamiliar with these requirements, please seek the advice of legal counsel. )Site: The General Hospital CorporationMass 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 Pediatric Psychopharmacology & Adult ADHD Program is seeking a college graduate for a part-time Research Coordinator (CRC) position investigating how to predict and diagnose mental health diagnoses in children. This is an excellent opportunity for someone interested in pursuing graduate school in clinical psychology, cognitive neuroscience, or medicine. The ideal candidate must be self-motivated, mature, and responsible with excellent organizational, as well as oral and written communication skills. You must be able to work independently in a dynamic environment, juggle and prioritize multiple tasks, feel comfortable working with clinical and non-clinical study populations, and seek assistance when appropriate.**Qualifications*** Collects & organizes patient data* Maintains records and databases* Uses software programs to generate graphs and reports* Assists with recruiting patients for research trials* Obtains patient study data from medical records, physicians, etc.* Verifies accuracy of study forms* Updates study forms per protocol* Documents patient visits and procedures* Assists with regulatory binders and QA/QC procedures* Assists with interviewing study subjects* Administers and scores questionnaires* Provides basic explanation of study and in some cases obtains informed consent from subjects* Performs study procedures, which may include phlebotomy, running MRI scans, and PET scans* Assists with study regulatory submissions* Writes consent forms* Verifies subject inclusion/exclusion criteria* Performs administrative support duties as required**Additional Job Details (if applicable)***Remote Type**Onsite**Work Location**55 Fruit Street**Scheduled Weekly Hours**0**Employee Type**Per Diem**Work Shift**Day (United States of America)**Pay Range**$19.76 - $28.44/Hourly**Grade**5At 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

Site: The General Hospital CorporationMass 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 SummaryWorking as a part of the Site at the Neurological Clinical Research Institute (NCRI), and working in collaboration with the multidisciplinary team, the incumbent will be responsible for supporting all aspects of clinical research coordination for studies at the NCRI. The research trials may include treatment trials, biomarker trials, imaging trials, and other research. The incumbent will be responsible for generating reports and maintaining records related to the assigned research studies. The incumbent will also provide administrative support to the professional and support staff of the NCRI, which may include providing support in the Amyotrophic Lateral Sclerosis (ALS) Clinic.QualificationsPrimary Responsibilities include, but not limited to:· Coordinates all activities of the subjects participating in the individual research studies, such as scheduling patients for the research study and collecting, organizing, and documenting the patient data from the visit.· Maintains records and databases.· Assists with recruiting patients for clinical trials.· Obtains patient study data from medical records, physicians, etc.· Verifies accuracy of study forms.· Updates study forms per protocol.· Prepares data for analysis and data entry· Assists with regulatory binders and QA/QC procedures· Administers and scores questionnaires.· Provides basic explanation of study and, in some cases, obtains informed consent from subjects.· Performs study procedures such as phlebotomy, vital signs, and electrocardiogram.· Draft consent forms.· Corresponds with the Institutional Review Board (IRB) for approval of protocol, notification of adverse events, continuation of study, annual reporting of studies, and submission of amendments.· Assists professional staff with patient treatment according to study guidelines. For example, arranges specific blood draws; performs phlebotomy; processes fluids; records medical histories; sets up room for study-specific procedures.· Knows their primary study thoroughly so that they can answer questions (from study staff and patients) accordingly, such as the timing of tests or protocol required lab orders.· Assures investigators receive results of tests, as appropriate.· Provides, creates, and maintains record-keeping systems: data collection forms, consent forms, side effect sheets, drug accountability and medication logs, initialization forms, and case report forms (CRFs).· Data entry of information into study databases.· Communicate with the study sponsor, including scheduling/conducting monitoring visits.· Works cooperatively with the study sponsor to ensure that good clinical practices are being followed.· Interacts internally with other hospital departments such as Dieticians, Harvard Catalyst CRC, Pharmacy, and Environmental Services as needed, and externally with personnel of regulatory agencies.· Performs other administrative support duties as assigned· Accepts responsibilities for special projects as requested.· Other job-related duties as required.Additional Job Details (if applicable)SKILLS/ABILITIES/COMPETENCIES REQUIRED:Conduct appropriate decorum with direct contact with a terminal patient populationAbility to multitask.Careful attention to detailsGood organization skillsAbility to follow directionsExcellent verbal and written communication skills.Able to work with deadlines and at times stressful environment.Computer literacyAbility to interact well with others and work well, as a part of a team, with minimal supervision a must.EDUCATION:Bachelor's degree requiredEXPERIENCE:Relevant coursework or project work.An understanding of federal regulations (i.e. FDA, CFR, etc.)IRB review process, informed consent, trial design, data monitoring, as well as good writing and editing skills a plus.Prior experience working in clinical research is a plus.WORKING CONDITIONS:Office work. May have a rotating 8 hour shift on Tuesdays between 7:30am and 6:30pm.May travel.Exposure to dry ice and -80degree freezers.May have to lift up to 20lbs and apply force to resist patients/subjects in hand held dynamometry.May be exposed to bodily fluids, including blood, urine, and cerebral spinal fluid.May work at different MGH or Partners sites including Main Campus, Charles River Plaza, and Charlestown Navy Yard.Remote TypeOnsiteWork Location165 Cambridge StreetPay Range$19.76 - $28.44/HourlyGrade5At 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

Site: The General Hospital Corporation

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.

Job Summary

IN THE CORRIGAN MINEHAN HEART CENTER YOU WILL GET:

• Exposure to cutting edge clinical trials in a collaborative team environment.
• Strong mentorship and education from physician-investigators.
• Direct patient interactions.

• Subject recruitment and enrollment.
• Maintenance of trial IRB and regulatory documentation.
• Study finance management.
• Acting as liaison with internal and external collaborators and sponsors to move trials forward.
• Managing research data, biological samples, and supporting other research project operations as needed.

• Strong interpersonal and communication skills, including the ability to interact with patients and study subjects.
• Excellent attention to detail.
• Capability to work well independently and within a multi-disciplinary team.
• Ability to balance and prioritize multiple dynamic projects and commitments.
• Willingness to commit to at least two years in the position is preferred.

Job Location:Methuen, MAExpected Start Date: August 2025Company Description:Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms.No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements.Job Description:No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives.Job Duties:Maintaining regulatory binders, inventory of study-specific and clinical supplies.Recruiting, and enrolling study subjects.Obtaining informed consent.Collecting nasal swab samples.Testing samples on investigational laboratory PCR analyzers.Data collection and entry.Query resolution.Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc.Key Success Factors:Ability to work independently.Desire to work in a clinical environment with direct patient contact.Genuine interest in research.Timely in all communications.Superior attention to detail.Self-motivatedWhile not a requirement, senior pre-medical students who hope to gain experience in clinical research or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees.Job Type: Full-timePay: $22.50 - $25.00 per hourExpected hours: 40 per weekBenefits:401(k)Dental InsuranceHealth InsurancePaid time offVision InsuranceSchedule:Monday to FridayWork Location: In person

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Provides critical support to Medical Affairs, specifically with the Investigator Initiated Studies (IIS) Program, tracking of Non-Disclosure Agreements (NDAs) and granted study agreements, as well as managing the tracking and shipping of medical devices.

Key Accountabilities

• Maintain accurate records of all NDAs and research agreements
• Monitor the status of research agreements and ensure timely execution
• Manage the inventory of medical devices used in Investigator Initiated Studies, including coordination of shipments and returns of loaned devices to and from research sites
• Maintain approprate records to support successful reporting for loaned / free-of-charge materials; attend audits of compliance records as neeeded
• May support the clinical affairs team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
• Coordinate and communicate with investigators, and legal and compliance teams to address any issues or delays
• Work with logistics and supply chain teams to resolve any shipping issues
• Performs other duties and responsibilities as assigned.

Networking/Key relationships

• Medical Affairs
• Operations (Logistics)
• Legal and Compliance
• External Stakeholders (Investigators, clinical study participants, etc)

Minimum Knowledge & Experience for the position:

• High School Diploma or equivalent required
• 3 years of administrative support experience

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Strong working knowledge of Microsoft Word, Excel, and PowerPoint
• Demonstrated written and oral communication skills
• Detail-oriented and highly organized
• Ability to work independently
• Great attention to detail and exceptional organization skills.
• Respects the need for compliance to applicable regulatory requirements.

Travel requirements:

Up to 5% of time. Periodic travel may be required to other Werfen sites.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

1. Recruit and enroll eligible study participants from clinics throughout the hospital and other sites.
2. Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion.
3. Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports, and other documents.
4. Capture clinical information from record review and patient interview into study database.
5. Manage and maintain regulatory documents for audit by FDA, as needed.
6. Prepare and manage regulatory documents for audit by FDA, as needed.
7. Evaluate and update medical records and maintain study database.
8. Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator.
9. Conduct regular review of study progress and follow-up.

EXPERIENCE:

1. Background in biology, immunology, biochemistry, biostatistics, epidemiology or related pre-medicine discipline preferred, but not required.
2. Experience in a clinical research environment or with specimen biobanking preferred.
3. A 2-year commitment is preferred, but not required.

When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.The Innovation in Cancer (ICan) Program is a vibrant and fast-growing multi-disciplinary team conducting Early Drug Development through Phase 1 clinical trials. We conduct cutting-edge research with novel anti-cancer drugs including immunotherapies and targeted drugs, with many of the trials being First-in-Human studies. The overarching goal of the ICan program is to push the boundaries of biomedical research to change the practice of oncology, discover new treatments and transform the lives of patients living with cancer. The ICan Program is seeking a Clinical Research Coordinator (CRC) with an interest in investigational drugs to have oversight over multiple research projects and support our growing program. The CRC will work closely with patients, providing the resources and close cooperation of many specialists with deep expertise in diagnosing and treating oncology patients. The CRC will work independently, or with general direction, manage and coordinate clinical research protocols, as directed by the Program Manager or Principal Investigator (PI). The CRC will also have the opportunity to learn certain aspects of oncology including but not limited to prevention, early detection, treatment/medication management, and end of life care for cancer patients. This position is an entry-level position focused on patient tracking from enrollment through completion of the study, data entry, and laboratory work. This position's focus will be with clinical trial sample processing, tracking, and shipment and data entry. This position may include patient visit preparation and some limited patient assessments such as collection of electrocardiograms. There may be regulatory and quality exposure in this position. The position typical hours will be from 10:00AM to 6:30PM, but may require later hours depending on patient visits and trial requirements.Job Description:Primary Responsibilities:1. Independently or in conjunction with other clinical research staff and/or research nurse, recruits and enrolls research subjects onto clinical research projects according to study protocols. May assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. (essential)2. Checks all eligibility and ineligibility criteria with the research subjects' medical record. Verifies information with clinical research nurse and/or principal investigator. (essential)3. Discusses informed consent with research subjects. Interacts with research subjects prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests. (essential)4. Learns protocol and monitors strict adherence to protocols by physicians, nurses and research subjects. Reviews protocol requirements with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins to learn how to independently resolve problems with protocol. (essential)5. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols. Enters data into computerized system. (essential)6. Assists clinic staff in obtaining insurance approval for subject protocol participation and scheduling tests and arranging admissions or outpatient visits for subjects. (essential)7. Assists investigator with correspondence with IRB. (essential)Required Qualifications:Bachelor's degree required.0-1 year of related work experience required.Medical terminology.Working knowledge of computer systems required, including web-based applications and some Microsoft Office applications, which may include Outlook, Word, Excel, PowerPoint or Access.Competencies:Decision Making: Ability to make decisions that are based on specific instructions, standard practices and established procedures which generally require little or no supervision.Problem Solving: Ability to address problems that are routine, somewhat repetitive and generally solved by following clear directions and procedures and by identifying opportunities for process improvements.Independence of Action: Ability to follow general instructions and procedures as provided. Work is monitored by supervisor/manager.Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.Teamwork: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.Physical Requirements:Light work: Exerting up to 20 pounds of force frequently to move objects. Some elements of the job are sedentary, but the employee will be required to stand for periods of time or move throughout the hospital campus.As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment. Learn more about this requirement.More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.Equal Opportunity Employer/Veterans/Disabled