Post Job

Clinical Research Coordinator Jobs in Lowell, MA

- 648 Jobs
All
Clinical Research Coordinator
Clinical Research Associate
Senior Clinical Research Coordinator
Clinical Trial Coordinator
Clinical Research Manager
Clinical Trial Manager
Study Coordinator
Clinical Research Scientist
Clinical Research Specialist
Clinical Research Administrator
Senior Research Coordinator
Research Project Coordinator
Clinical Trials Associate
Clinical Scientist
Research Administrator
  • Clinical Trial Scientist

    Prokatchers LLC

    Clinical Research Coordinator Job 22 miles from Lowell

    You have acquired 7+ years of experience in clinical research/development/real world evidence (RWE); scientific study design, strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation. You have deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics. Your skills include a demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices. You have strong writing skills to product quality clinical documents, including final reports. Strong knowledge and experience with study design is also desired. You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.
    $112k-142k yearly est. 20h ago
  • Clinical Trial Associate

    Beacon Hill 3.9company rating

    Clinical Research Coordinator Job 22 miles from Lowell

    Job Title: Clinical Trial Associate Contract Term: 6 months to start; could extend Experience required: Biotech/pharma preferred Position Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment. Key Responsibilities: Organize/maintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-out Assist with the development and review of clinical documents including protocols, ICFs and clinical study plans Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision Facilitate vendor engagement from RFP distribution through to final contracting and PO set up Setup and organize Sharepoint and central study files Coordinate training for the assigned clinical study Manage study laboratory sample tracking and vendor management support Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages Support Clinical Operations team with specific projects Effectively communicate with study team members and work closely to address challenges Minimum Qualifications BS/BA degree or equivalent and at least one year experience in clinical operations in Sponsor company with 1+ years strongly preferred Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations Experience with eTMF; ability to directly apply essential document knowledge to file documents Effective communication, organizational and interpersonal/team skills Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred. Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines Participate in inter-departmental workgroups to create or enhance processes Strong attention to quality/detail Good organizational and time management skills Willingness to work in a flexible environment Preferred Qualifications Experience with global studies, using an outsourced CRO model Experience in clinical drug development Experience with regulatory affairs, including IND/CTA submissions Experience working for gene therapy/ gene editing companies Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: ***************************************** Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: ***************************************** Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. "
    $76k-126k yearly est. 12d ago
  • Contract Clinical Trial Manager, Clinical Operations 2070536

    Stratacuity: Proven Scientific Placement

    Clinical Research Coordinator Job 11 miles from Lowell

    Focus: Rare Disease Job Overview: The Clinical Trials Manager oversees moderate-complexity clinical trial execution, ensuring adherence to protocol, budget, and regulations, while addressing issues and supporting process improvements. Primary Job Responsibilities: Oversees Phase 1-3 clinical studies, ensuring adherence to timelines, budgets, and plans with CRO and vendor collaboration. Leads the selection and qualification of Investigators and vendors. Contributes to the development of clinical study protocols and documents. Develops operational plans and maintains timelines through coordination with internal teams. Identifies and mitigates study risks, ensuring alignment with stakeholder expectations. Manages drug supply coordination with CMC for consistent site delivery. Assists in budget management and financial forecasting for resource allocation. Enhances operations through project management skills, improving performance and SOPs. Primary Job Requirements: Scientific/healthcare Bachelor's or higher, with 4-6 years of clinical operations experience in the industry. Deep knowledge of ICH-GCP and drug development processes, ensuring compliant clinical trial operations. Experienced in key site visit processes, with a preference for Rare Disease and Neurology study experience. Proficient in Microsoft Office and MS Project, enabling efficient clinical trial management. Strong communicator, able to work both independently and in team settings, adaptable to fast-paced environments. Analytical, with excellent problem-solving and multitasking skills, capable of prioritizing multiple projects. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
    $76k-121k yearly est. 9d ago
  • Clinical Trial Manager

    Genabio Diagnostics

    Clinical Research Coordinator Job 11 miles from Lowell

    Job Responsibilities: Manage assigned clinical studies within a designated budget and timeline. Conduct CRO, Vendor and site assessment and selection; negotiating budget and contracts. Conduct site qualification, initiation, interim monitoring and close-out visits. Collecting and reviewing trial master documentation. Document results of visits in monitoring reports for review and finalization. Facilitate IRB submissions and renewals when needed. Oversee clinical sites, central lab, and other third parties to ensure issues are resolved timely. Motivating investigational sites to close queries and action items. Develop or review clinical project plans and clinical trial documentation. Collaborate with Regulatory to prepare FDA pre-submission and submission packages. Oversee the development of a clinical study database by third party, review and summarize clinical data, perform data analysis and reports. Oversee all study team members training to ensure accurate execution of clinical protocols. Qualifications: Bachelor's degree (or higher) in science or health-related discipline Minimum 3 years of clinical research experience for medical device and IVD products, specialty in respiratory diseases or STD is preferred Strong understanding of GCPs, ICH, and knowledge of regulatory requirements Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization Ability and willingness to travel ~10-15% of the time
    $76k-121k yearly est. 29d ago
  • Sr. Clinical Trial Manager

    Proclinical Staffing

    Clinical Research Coordinator Job 27 miles from Lowell

    Sr. Clinical Trial Manager - Contract - Boston, MA Are you looking to drive groundbreaking medical research and make a real impact-join us as a Sr. Clinical Trial Manager and lead the way in advancing clinical trials! Primary Responsibilities: This role involves managing trial start-up, maintenance, and closure while ensuring compliance with ICH-GCP standards and internal policies. You will play a crucial role in maintaining data integrity and quality across projects, working closely with vendors and stakeholders. Skills & Requirements: Experience in leading clinical operations for Neuro and Cell & Gene Therapy trials. Strong understanding of ICH-GCP guidelines and clinical trial regulations. Excellent project management and leadership skills. Ability to manage multiple stakeholders and cross-functional teams. Proficiency in maintaining trial documentation and ensuring inspection readiness. Strong problem-solving skills and ability to propose process improvements. Effective communication skills for interacting with external partners and vendors. The Sr. Clinical Trial Manager's responsibilities will be: Lead clinical trial operations, ensuring adherence to timelines, budget, and scope. Ensure compliance and quality management, maintaining accurate documentation and trial master files. Define and execute quality control steps, including study performance metrics. Guide and manage stakeholder communications regarding clinical trial information. Oversee clinical monitoring activities and ensure regulatory compliance. Support Trial Master File strategy and inspection readiness activities. Coordinate data review activities and manage protocol deviation reviews. Provide clinical supply projections and approve demand. Lead project team meetings and mentor team members. Contribute to study protocol development and clinical system design. Conduct study feasibility and ensure proper site selection and setup. Serve as the primary contact for project communication and coordination. If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
    $76k-122k yearly est. 17d ago
  • Senior Research Administrator (632306)

    The Planet Group 4.1company rating

    Clinical Research Coordinator Job 27 miles from Lowell

    Seeking a Contract to Potentially Hire Permanently Senior Research Administrator for Prestigious Hospital in Bostone. On-Site. 32 hours a week, 6+ Months. $41-$44/hr. Apply here or call me at ************ Senior Research Administrator Contract: 6+ months Onsite: Boston, MA 02115 Must Haves: Bachelors Degree 4+ of research administrative experience Experience working heavily with financial aspects of grants/research administration Analytical skills, proficient to expert level in Excel Preferred: Research Administration Certification (CRA) Healthcare industry experience Job Description: a healthcare system is seeking a Senior Research Administrator to support the pre & post award process. Responsibilities include:
    $41-44 hourly 13d ago
  • Clinical Research Scientist

    Healthcare Financial, Inc. 3.7company rating

    Clinical Research Coordinator Job 31 miles from Lowell

    Winner of the Best and Brightest Companies to Work for in Boston and in the Nation by the National Association for Business Resources (NABR) for the third consecutive year. Join Our Team as a Part-time (20 Hours) Clinical Research Scientist Are you passionate about leveraging data and medical research to drive meaningful change in healthcare? We are seeking a Clinical Research Scientist to join our dynamic Data Science team. In this role, you will conduct medical research, analyze clinical and claims-related healthcare data, and contribute to the development of machine learning algorithms and statistical data analysis to assess SSI/MC eligibility. Key Responsibilities: Collect and coordinate data from various sources, including claims, medical records, and lab results. Support the data science team in identifying relevant datasets and resolving short-term research-related questions. Conduct statistical analysis and programming on large, complex datasets. Implement advanced statistical and programming techniques for sophisticated quantitative research. Identify key business questions or hypotheses for analysis. Utilize Excel, statistical analysis, and research methodologies to analyze trends and enhance decision-making. Ensure accuracy and validity of methods and results, working independently with sound judgment. Conduct online and other research to support data-driven insights. Collaborate with analysts and data scientists to integrate expanded datasets and query techniques. Provide medical and clinical insights for the assessment of client members. Contribute to the evaluation and enhancement of data-driven clinical products. Educate clients and internal stakeholders from a medical/clinical perspective. Stay updated with the latest literature, emerging policies, clinical developments, and guidelines. What We're Looking For: Bachelor's Degree from a medical school and Public Health background, demonstrating strong analytical and quantitative skills. 1-3 years of relevant analytical experience in healthcare (e.g., health plans, hospitals, medical research organizations). Strong fluency with Excel and knowledge of statistics. Familiarity with statistical software (SPSS, SAS, STATA) and Microsoft Office Suite. Coding familiarity with R, SQL, or Python is a plus. Experience with data visualization tools (Tableau, Power BI) and dashboarding software. Strong analytical thinking and problem-solving skills. Keen attention to detail with the ability to manage multiple projects and deadlines. Effective verbal, written, and interpersonal communication skills. Self-driven, results-oriented, and able to thrive in a fast-paced environment. Why Join Us: Competitive salary and comprehensive benefits package. Opportunities for career growth and development within a dynamic organization. Collaborative and inclusive work environment that values teamwork and innovation. Flexible work options: Remote or Hybrid. Our Massachusetts based starting annual salary for this role is 40K. The salary does not reflect total compensation, which includes a base salary, benefits and other options. EEO Statement: HFI is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. HFI is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. HFI will not tolerate discrimination or harassment based on any of these characteristics. HFI encourages applicants of all ages.
    $80k-123k yearly est. 5d ago
  • Clinical Research Associate

    Integrated Resources 4.5company rating

    Clinical Research Coordinator Job 15 miles from Lowell

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

    Alira Health 4.4company rating

    Clinical Research Coordinator Job 25 miles from Lowell

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

    Mindlance 4.6company rating

    Clinical Research Coordinator Job 15 miles from Lowell

    • Requires Bachelors degree from accredited US College or University can NOT be remote, no relocation • This is a 6 month contract - may be extended but not guaranteed • Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) • Experience with finances, accounting or invoicing a plus Qualifications • Requires Bachelors degree from accredited US College or University Candidate must have at least 1 year experience with clinical trials (CRO, Trial site or Sponsor) Additional Information All your information will be kept confidential according to EEO guidelines.
    $56k-79k yearly est. 5d ago
  • Clinical Research Finance Manager

    Iterative Scopes Inc.

    Clinical Research Coordinator Job 22 miles from Lowell

    Iterative Health is a healthcare technology and services company on a mission to advance gastrointestinal care through relentless innovation. With deep expertise in artificial intelligence and clinical research, we empower healthcare professionals to provide consistently high-quality colorectal cancer screenings and support clinical research teams and study sponsors to expand and accelerate patient access to novel therapeutics. What you'll be doing: In this role, you will act as the subject matter expert for clinical research site finances both internally, and externally. You will be a strategic partner to potential & existing clinical research sites within the Iterative Health network in order to establish and grow the research clinic's financial process and health. Key Responsibilities: * Iterative Health Activities * Support IH finance team with AR and AP as they relate to the RealTime platform and clinical research studies * Invoicing/ collections for clinical research sites * Monitor contract progress and invoice sponsors accordingly * Collect Precision enrollment data from Professional Services Team * Build new study profiles within CTMS in accordance with Clinical Trial Agreements (CTA) * Understand relationship between study protocol and Clinical Trial Agreement (CTA) * Create and maintain monthly Clinical Research Coordinator (CRC) visit report for all research sites * Site-facing Activities * Train sites on clinical research finances and financial activities best practices * Create and present monthly and end-of-year financial reports to key stakeholders at each research site with an eye towards continuous improvement * Liaise between site finance department and site research department * Conduct full study financial closeout reviews for each research site * Assist in setting up P&L and balance sheet (GAAP principles) * Guide use of patient stipend cards keeping overall site goals in mind * Reconcile research subject stipend cards * Work with Iterative Health's internal finance team to post sponsor study payments in research site CTMS, and ensure accuracy and quality control * Assist research sites in creating and distributing research study invoices to sponsor * Make appropriate changes to financial institutions information (e.g., updating financial data in the CTMS, updating third party vendor costs in the CTMS) * Manage CDA and CTA process with IH site network * Sponsor-facing Activities * Negotiate study budgets between the site and the Sponsor/CRO, and IH * Work with study sponsor financial contact to ensure invoicing is accurate, and sponsor payments are timely Required skills: * At least 7 years' experience working with clinical research finance, for a research site * 5+ years experience in a strategic customer facing role * Strong working knowledge of invoicing, tracking account payable/ receivable, and clinical research budgets * Knowledge of a Clinical Trials Management System (CTMS); RealTime and/or CRIO is required * ~15% travel required * Willingness to occasionally work outside of normal working hours in your timezone to accommodate varying time zones Preferred skills: * Knowledge of Generally Accepted Accounting Principles (GAAP) * Bachelor's degree New York pay range $110,000-$130,000 USD Some of our benefits include: * Vision/Dental/ Medical Insurance * Life/Disability Insurance * Parental Leave * Stock Options * Flexible Work Hours * Unlimited Paid Time Off At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
    $110k-130k yearly 60d+ ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical Research Coordinator Job 27 miles from Lowell

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K
    $60k-92k yearly est. 60d+ ago
  • Lead Clinical Research Associate

    Bicara Therapeutics Inc.

    Clinical Research Coordinator Job 27 miles from Lowell

    As a Lead Clinical Research Associate (CRA) at Bicara Therapeutics, you will support the planning and execution of clinical trials to ensure they meet regulatory standards and timelines. This role will primarily focus on monitoring clinical trial data, site management, ensuring compliance with Good Clinical Practice (GCP), and assisting in various aspects of clinical trial management. You will work closely with study teams, clinical sites, and vendors to support trial execution and provide critical operational support. Key Responsibilities: * Assist in the preparation, initiation, and execution of clinical trials, ensuring adherence to timelines and regulatory requirements. * Assist with site selection and initiation including attendance at remote or onsite site evaluation visits (SEVs) and site initiation visits (SIVs), ensuring site and staff qualification and readiness to conduct clinical trial. * Attendance at remote or onsite interim monitoring visits (IMVs) and/or close out visits (COVs) ensuring the proper implementation of clinical trial protocols, study plans and regulatory requirements. * Review and maintain clinical trial documentation, ensuring it is complete, accurate, and compliant with all regulatory requirements. * Support the preparation of regulatory submissions. * Ensure that all trial activities are conducted according to the study protocol, GCP, and applicable regulations. * Track and report clinical trial metrics and site performance, helping to ensure that studies stay on schedule and within scope. * Review and monitor study reports and assist in resolving any issues regarding adverse events or protocol deviations. * Maintain accurate, up-to-date files for all clinical trial documentation, ensuring compliance with internal standard operating procedures (SOPs) and regulatory guidelines. * Support Sponsor oversight activities including risk management, eTMF reviews, and oversight visits, reporting, and follow-up. * Liaise with CRO partner and other internal and external stakeholders in day-to-day operations of outsourced clinical trial activities * Ability and willingness to travel as needed (up to 50%, with potential for increase during start-up, data locks and close-out) Qualifications: * Bachelor's degree in Life Sciences or a related field * Minimum of 2 years of experience as a Clinical Research Associate or in clinical trial management, with a focus on site management and trial monitoring of Phase I, II, and II studies; oncology experience with both Sponsor and CRO preferred. * Current ICH GCP training (within the last 3 years) * Experience with Medidata Rave and CTMS * Excellent organizational and time-management skills with the ability to manage multiple tasks and priorities. * Strong attention to detail and accuracy in data management and documentation. Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit ************** or follow us on LinkedIn or X. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
    $60k-92k yearly est. 7d ago
  • Clinical Research Associate

    Stratacuity

    Clinical Research Coordinator Job 27 miles from Lowell

    Clinical Research Associate 2064742Location: Boston, MA (Onsite) Focus: OncologyJob Overview: Join our client as the inaugural in-house Clinical Research Associate to oversee quality and patient safety, coordinating with a CRO and facilitating daily study operations. Primary Job Responsibilities:Partner with CROs for trial monitoring, maintaining compliance, data accuracy, and site relations. Perform site visits to ensure protocol compliance and manage essential documentation. Build relationships with study sites and vendors, and develop monitoring tools for data review. Assist in audit support, track enrollment, oversee data collection, and collaborate on study goals. Primary Job Requirements:Bachelors degree with 6 years of clinical trials experience Skilled in managing complex oncology studies with a quality and compliance emphasis. Solid understanding of ICH/GCP, regulations, and relationship-building with sites/vendors. Willing to travel 50% and adept with Microsoft Office, EDC, CTMS, and eTMF. About Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems. com or ************.
    $60k-92k yearly est. 41d ago
  • Senior Research Coordinator

    Ophthalmic Consultants of Boston 3.4company rating

    Clinical Research Coordinator Job 36 miles from Lowell

    Ophthalmic Consultants of Boston (OCB) was established in 1969 to offer patients the highest quality eye care and laser/surgical treatment. OCB is the premier eye care provider in the region with nineteen practice locations in the greater Boston area, South Shore, and Cape Cod. OCB ophthalmologists use the most advanced diagnostic, laser and surgical techniques available, and their level of care has earned Ophthalmic Consultants of Boston a national and international reputation for excellence. Are you a team player, energized by superb patient care and impressed by efficient operations of a world-class health care provider? Are you looking to continuously bringing your skills to the next level while getting recognized by the great work you do? Participates in training of new research coordinators and assistants on GCP guidelines, SOPs, and clinical skills, and serves as a resource for study team members on questions and issues as they arise. Oversees or directly coordinates multiple research studies, including enrolling subjects, conducting study visits, maintaining data, and communicating with study sponsors, monitors, and regulatory personnel in writing and in person. We are currently hiring a Senior Research Coordinator/Technician for our Retina Team. This is a multi-site location opportunity working in our Weymouth, Waltham, and Boston locations. Performance Requirements: Working knowledge of theory and application of FDA and ICH Good Clinical Practice (GCP) guidelines. Excellent organizational, interpersonal, computer, and verbal/written communication skills. Working knowledge of anatomy and physiology of the eye. Understanding of the theory and the workings behind specific testing. Possesses a clear understanding of pertinent tests, including the “why,” “how,” and “when” behind pertinent testing. Knowledge of ocular diseases. Knowledge of systemic diseases and their impact on the eyes. Ability to travel between OCB office locations such as Boston, Weymouth, and Waltham, as needed. Education and Experience: Preferred: COT/COA and Clinical Research Coordinator (CRC) certification. At least 3 years research coordinator experience required. Bachelor of Science degree preferred. Example of Responsibilities: Participates in training of new research coordinators and research assistants on GCP guidelines, team policies/ procedures, and clinical skills. Functions as helpful and resourceful liaison between research team and clinical teams to ensure productive use of limited resources such as physician time, exam lanes, supplies and equipment. Coordinates Investigator-initiated studies. Identifies the need for new or revised research policies and procedures and brings these to Research Manager or Research Director as appropriate. Assists Investigator/Practice Manager/Practice Research Director in design, updating, and implementation of research programs standard operating procedures. Also includes all responsibilities of a Research Coordinator: Actively applies knowledge of FDA and ICH Good Clinical Practice guidelines throughout study performance to ensure compliance with these standards. Primarily responsible for acquiring detailed knowledge of components of assigned studies, including protocol, masking, scheduling, reporting and related issues and ensuring all aspects of study performance are in accordance with the protocol. Obtains informed consent, coordinates screening of possible candidates, and enrolls participants in clinical trials, in accordance with team's enrollment goals. Conducts study patient visits through direct patient care (including manifest refractions, visual acuity examinations, intraocular pressure readings, electrocardiograms, phlebotomy, etc,) and through coordination with Testing Department and study fellows and attending physicians. Maintains accurate accountability of investigational drug/product. Maintains accurate and comprehensive study files, including completion and maintenance of source documents, case report forms, regulatory documents and required logs. Function as primary liaison between Investigator, participants, sponsor, monitor, and regulatory bodies for assigned studies: Function as primary liaison between Investigator, participants, sponsor, monitor, and regulatory bodies for assigned studies: Obtains and maintains approval of institutional review boards and FDA, as required. Establishes and maintains a professional working relationship with all study participants. Communicates with Investigator, Practice Manager and other team members about progress of studies and issues as they arise. Communicates with study sponsor and monitor and promptly and accurately seeks resolution of and responds to monitor queries. Benefits Offered: Health & Dental Insurance- eligible 1st day of employment Paid time off and paid holidays Health & Dependent Reimbursement Accounts 401(k) Plan with company contribution Company paid Life and LTD Insurance Employee discounts To find out more about OCB, please visit our website at ****************** OCB is an Equal Opportunity Employer. All Employees must be fully vaccinated.
    $76k-96k yearly est. 60d+ ago
  • Sr Clinical Research Coordinator

    System One 4.6company rating

    Clinical Research Coordinator Job 24 miles from Lowell

    Title: Clinical Research Coordinator Type/Duration: Contract, 6 month/renewable, 100% onsite Schedule: Monday-Friday, core daytime business hours based on clinic hours, could have some earlier morning starts Summary of Key Responsibilities : Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and monitoring while the subjects are on study. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports. Duties and Responsibilities: Duties include but are not limited to: - Supports enrolling patients onto the clinical trial through screening, enrollment and follow up of eligible subjects according to protocol requirements - Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance - Collects, completes, and enters data into study specific case report forms or electronic data capture systems - Ensures timely and accurate data completion - Collects blood samples and tracks shipments and requests supplies as needed - Implements study-specific communications - Ensures timely adherence to protocol requirements - Responsible for completion of all required documentation - Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications - Communicates all study-related issues to appropriate study colleagues or manager - Apprises principal investigator and management of all study specific medical issues for guidance - Attends study specific meetings as required or asked to do so - Reviews and responds to any monitoring findings and escalates issues Ref: #568-Clinical System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
    $60k-93k yearly est. 3d ago
  • Senior Clinical Research Coordinator - Clinical Research Coordinator Core

    Beth Israel Lahey Health 3.1company rating

    Clinical Research Coordinator Job 27 miles from Lowell

    **Job Type:** Regular **Time Type:** Full time **Work Shift:** Day (United States of America) **FLSA Status:** Non-Exempt **When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.** This position is part of the BDIMC Clinical Research Coordinator Core at Beth Israel Deaconess Medical Center (BIDMC). The Clinical Research Coordinator Core provides support for investigator-initiated and sponsor-initiated research for investigators across the departments and divisions of BIDMC. This position is responsible for managing/overseeing the recruiting, screening and enrolling of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including assisting with the grant application process and monitoring expenses for all protocols. Supervisory duties including overseeing the progress of protocols; supervising, planning and prioritizing the work of the Clinical Research Coordinators. **Job Description:** **Essential Responsibilities:** + Participates in hiring and training Clinical Research Coordinators. Monitors performance of staff. Contributes to annual performance evaluations of staff. Ensures that schedules, follow up and completion of research protocols progress as planned. Works with staff to resolve day-to-day problems. (essential) + Assists in the execution of new IRB applications and processes annual reviews for the IRB committees with regard to consents. May attend IRB meetings as required or address IRB questions regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and terminations to the IRB for review and approval. (essential) + Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients. Revises protocol consent form to comply with federal, state and IRB guidelines. (essential) + Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with clinical research nurse and/or principal investigator. May enroll patients onto clinical trials. (essential) + Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors and/or pharmaceutical company representatives. May prepare reports for pharmaceutical company monitors as well as routine audits for the FDA, if applicable. (essential) + Monitors strict adherence to protocols by physicians, nurses and patients. Reviews protocol requirements with physicians, nurses and fellows. Identifies and resolves problems with protocol compliance. Keeps principal investigator and research nurse aware of any problems. (essential) + Prepares records for audits. Interacts with industry or sponsoring organization representatives to review records at time of audits. Answers queries from sponsoring organization regarding ambiguous or incomplete data. Monitors quality and timeliness of data submissions. Ensures data extracts completed by staff are in compliance with protocols. (essential) + May assist physician investigator in reviewing data from research protocol in order to assess efficacy of therapy and make subsequent treatment decisions. Serves as a resource to physicians and nurses to locate information for special reports and treatment decisions. (essential) + Ensures compliance with funding agencies and assists principal investigator in the preparation of annual progress report of the grant. May oversee the application process for grants. Develops financial and statistical reports. Monitors expenses related to each protocol. May work to prepare budget. (essential) + May assist the principal investigator in obtaining new sources of funding and negotiating with prospective sponsors and collaborating institutions. Must have full understanding and ability to explain research protocols thoroughly including goals, methods and design. (essential) **Required Qualifications:** + Bachelor's degree required; Master's degree preferred. + 1-3 years of related work experience in a medical setting; clinical research setting preferred. + Knowledge of Medical Terminology. + Working knowledge of computerized applications, including web-based applications and Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access. **Competencies:** **Decision Making:** Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance. **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. **Team Work:** 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 Nature of the Job:** 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) and COVID-19 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**
    $54k-88k yearly est. 22d ago
  • Clinical Research Specialist

    Nashoba Learning Group 2.8company rating

    Clinical Research Coordinator Job 11 miles from Lowell

    Job Details Nashoba Learning Group Bedford - Bedford, MADescription Job Title: Clinical Research Specialist Schedule: Monday - Friday, full time at 35 hours per week; year-round, onsite Supervisor: Director of Applied Research Position Summary: The Clinical Research Specialist will support the development, implementation, and dissemination of ongoing research at NLG. This role will focus heavily on the integration of clinical practice and research in the assessment and treatment of severe problem behavior, but may include other areas of research as well. Responsibilities will include working with the Director of Applied Research to identify clinical needs that can be addressed through research, recruiting participants internally, conducting or supervising sessions, collecting data, and preparing data for publication. The Clinical Research Specialist will also work with participants' clinical team to provide training, recommendations, or support following a participant's discharge from a study, or to assist the team in implementing a particular evidence-based practice. Responsibilities: Position Specific Responsibilities Work with Director of Applied Research to determine research priorities, including providing support to high-need cases both within the research process and outside of it Design and conduct functional analyses in collaboration with participants' clinical team, including conducting open-ended interviews, observations, and interview-informed synthesized contingency analyses Design and supervise the implementation of treatments to address severe problem behavior, in collaboration with participants' clinical team Oversee participants' progress through research projects, including but not limited to conducting or supervising research sessions, collecting, graphing, and interpreting data, and meeting with the participants' clinical staff to share progress updates Organize and maintain data files for all students who participate in research Work with Director of Applied Research to plan future projects, including writing and submitting IRB applications Work with Director of Applied Research to prepare manuscripts for publication, including conducting literature reviews, preparing visual displays of data, and writing sections of the manuscript Represent NLG at professional conferences by presenting our research, conducting workshops, speaking on discussion panels, or similar conference activities Participate as a member of NLG's weekly Behavior Council meetings to review complex cases Regularly reflect on practice, seek and respond to feedback, and demonstrate self-awareness and commitment to continuous learning and development Participate in ongoing professional development activities to stay up to date with current topics in research and practice Complete other related duties as requested and meet regularly with supervisor General Responsibilities Reporting to work promptly at: 8:30am and remaining at work until 3:30pm (unless their responsibilities require them to come in earlier or stay later, which will occasionally occur). 15 minutes may be flexed before/after school hours as long as the employee works the required minimum 7 hours per day and their responsibilities for the day have been completed. Following NLG's emergency procedures (administering SOLVE strategies, First Aid or CPR), whenever needed. Adhering to NLG's policies and procedures expected for full time staff. Ensuring the safety and well-being of all students within NLG and while out in the community. Attendance at the following: Staff Meetings: All staff members are required to attend any mandatory staff meetings as scheduled which may be before, during, or after program hours.. Trainings: All staff members are required to participate in a minimum of 24 training hours each year. Staff will be assigned mandatory trainings to complete on Paycom. Additional trainings that fulfill this requirement can be found on Paycom, NLG University, and occasionally are provided by external trainers on the half days. Maintenance of the following certifications: CPR & First Aid The initial and renewal trainings are provided by NLG. The initial training occurs during the Orientation week. Renewal trainings are communicated by NLG's Nursing Department as necessary. SOLVE (see Physical Job Capabilities) The initial and renewal trainings are provided by NLG. The initial 16-20 hour training occurs within the first 3 months of employment. Staff members are expected to participate in an annual 1.5 hour refresher course to be scheduled via Paycom. Any other certifications/licenses as required per the position qualifications Please note: The essential functions listed in this section are not limited only to the tasks listed and may include other duties as assigned. Supervision and Performance Assessment: Nashoba Learning Group adheres to the principles of Applied Behavior Analysis in its management of employees as well as in its teaching of children. Performance requirements are clearly specified, performance is measured frequently, feedback is given immediately and mastery of particular skills allows access to higher-level skills. Reinforcement is tied to performance in the form of pay, professional development opportunities, and recognition. This position will be evaluated/assessed annually by Supervisor on general performance, cooperation, and teamwork. Qualifications Qualifications: Applicants must hold a BCBA in good standing and have completed the 8-hour BCBA supervisor training (or be willing to complete it upon hiring) Minimum 3 years' experience as a BCBA providing supervision or consultation for cases with complex clinical needs, including severe problem behavior Commitment to NLG's values of serving individuals with autism and their families in a compassionate and person-centered manner that prioritizes dignity, rapport, and choice Experience designing and conducting practical functional assessments for a variety of learner profiles Experience designing and implementing skill-based treatment for problem behavior, including thorough knowledge of each treatment component and the ability to apply it flexibly to meet individual learner needs Experience conducting behavior analytic single-subject design research preferred, but not required. We will train you. Willing to engage in public speaking activities such as internal staff training presentations or external presentations at conferences, workshops, etc. Strong writing skills, organizational skills, and time management skills Strong interpersonal skills, energy, work ethic, ability to work on a team, leadership skills, integrity, and the ability to accept and learn from feedback At least two references that will attest to the staff's interpersonal skills, energy, work ethic, ability to work on a team, leadership skills, integrity, and ability to accept and learn from feedback Satisfactory results for new hire and recurring background and CORI check A driver's license in good standing Thorough knowledge of NLG's policies and procedures Thorough knowledge of NLG's daily operations and guidelines Physical Job Capabilities: Physical Job Requirements of this job include: Physically capable of keeping students/members safe and in close proximity at all times, particularly during outings Safely implement crisis prevention techniques and restraining members 50 pounds up to and in excess of 125 pounds when necessary Physical Movements Required for Safe Implementation of Crisis Prevention Techniques: Quick and abrupt movements of upper and lower body (moving quickly, brisk and vigorous use of hands and arms) Rotating upper torso movements Arm and hand movements to grasp, range of motion movement with upper body and arms Balance Lifting and lowering (bending at knees repeatedly) Prolonged duration of exertion with both upper and lower body, being in one position for periods of time
    $59k-72k yearly est. 60d+ ago
  • Clinical Research Manager - Imaging

    Elucid 3.8company rating

    Clinical Research Coordinator Job 27 miles from Lowell

    We are a rapidly growing, Boston-based medical technology company using AI to help clinicians make more informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes! Our Clinical Development team is dedicated to providing evidence to support our products and drive the business forward. The Clinical Research Manager - Imaging plays a vital role in this mission by ensuring data quality and protocol adherence in clinical investigations. This role will manage imaging projects across global clinical sites, liaison with internal stakeholders and handle Core Lab relationships, ensuring seamless data transfer and compliance with PHI and HIPAA guidelines. The chosen candidate will bring a background in carotid and coronary imaging expertise, along with technical knowledge and project management skills, to effectively bridge key teams, including Clinical Operations, IT, Cybersecurity, and Data Management. The ideal candidate will have: * Bachelor's degree in science or related discipline or 5 years of related work experience. * Required minimum 2-5 years of experience managing operational aspects of clinical studies. * Strong project management, organizational, and communication skills to effectively share best practices with supporting teams. * Experience in project management related to clinical study start-up and execution. * A collaborative approach and experience working with cross-functional teams, including clinical research associates, engineering, quality control, and other clinical development teams. * Cardiac CT post-processing experience; Invasive Coronary Angiogram experience preferred. * Excellent written and verbal communication skills, with a proficiency in Microsoft 365 suite. Work Location: * This role is based out of our office in Boston, MA. For local candidates, we operate in a hybrid model with regular in-office collaboration. While we have a preference for local hires, if a candidate is outside of a reasonable commuting distance, we are open to remote arrangements for the right individual. Travel Requirements: * Periodic travel is required. * --------------------------------------------------- At Elucid, we believe the best work happens in a flexible hybrid environment. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed. We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability. We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid, even if you don't meet every qualification, we encourage you to apply!
    $81k-123k yearly est. 10d ago
  • Senior Clinical Research Coordinator

    Actalent

    Clinical Research Coordinator Job 24 miles from Lowell

    Job Summary: The Clinical Research Coordinator (CRC) Level III is responsible for overseeing and performing routine operational activities for multiple research protocols. This role involves liaising between site research personnel, industry sponsors, and supervisors, as well as collaborating closely with various site departments and teams. The CRC Level III will assist with training CRC Level I and II personnel, act as a role model to peers, and ensure compliance with all protocol requirements. General Duties: + Adhere to the "Code of Conduct" philosophy and "Mission and Value Statement." + Demonstrate ability to fulfill responsibilities and duties of CRC Level I and II. + Assist with training CRC Level I and II personnel. + Act as a role model to peers. Clinical Research Operations: + Perform routine operational activities for multiple research protocols. + Liaise between site research personnel, industry sponsors, and supervisors. + Collaborate with various site departments/teams, including finance, hospital administrative representatives, and the local IRB, if applicable. + Coordinate schedule of assessments from initial submission of feasibility until study closeout. + Coordinate submission and approval for the Site's Facility Review Committee, if applicable. + Provide awareness of research protocols to appropriate site-level personnel, including physicians, nurses, clinical staff, and administrators. + Document all specific tasks required by the protocol (e.g., medication forms, quality of life questionnaires, neuro exams, vital signs sheets, times of lab draws). + Accurately perform/calculate and document the BSA, mRS, NIHSS, STS risk score, or any other approved CRC task, as needed per protocol. + Document all patient, staff, and sponsor correspondence, including follow-up encounters, adverse events, interventions, pharmacy dispensations, and patient phone calls. + Ensure follow-up appointments, imaging, or any related procedures are scheduled correctly according to protocol requirements. + Accurately complete all data requests (including queries) and submit with source documentation within the timeframe specified in the SOP. + Re-consent patients in a timely manner and document the process appropriately. + Support the study team in mitigating risks and optimizing site compliance. Site Development: + Work with site personnel and local investigators to assess site feasibility and performance. + Regularly meet with physicians and administrators, when applicable, to assess study performance and investigator satisfaction. + Collaborate with other departments (non-invasive, finance, laboratory, etc.) to develop and implement processes in support of research activities. + Assist with providing a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.). + Guide research team members on the management of non-compliant data and/or study activities. Reporting and Analysis: + Monitor patient enrollment at the site through weekly reports and report results to the supervisor. + Facilitate continuing education and training to investigators, as applicable. Qualifications: + Proven experience in clinical research coordination. + Strong understanding of research protocols and compliance requirements. + Excellent communication and organizational skills. + Ability to collaborate effectively with various departments and teams. + Leadership skills and ability to act as a role model to peers Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision- Critical Illness, Accident, and Hospital- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available- Life Insurance (Voluntary Life & AD&D for the employee and dependents)- Short and long-term disability- Health Spending Account (HSA)- Transportation benefits- Employee Assistance Program- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Manchester,NH. Application Deadline This position is anticipated to close on Apr 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $30-35 hourly 1d ago

Learn More About Clinical Research Coordinator Jobs

How much does a Clinical Research Coordinator earn in Lowell, MA?

The average clinical research coordinator in Lowell, MA earns between $38,000 and $78,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average Clinical Research Coordinator Salary In Lowell, MA

$54,000

What are the biggest employers of Clinical Research Coordinators in Lowell, MA?

The biggest employers of Clinical Research Coordinators in Lowell, MA are:
  1. Ora
Job type you want
Full Time
Part Time
Internship
Temporary