Site Manager

3 weeks ago


Boston, United States DM Clinical Research Full time

Site Manager

The Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. Also To ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES

  • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
  • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
  • Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations.
  • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
  • Sponsor-provided and IRB-approved Protocol Training
  • All relevant Protocol Amendments Training
  • Any study-specific Manuals Training as applicable
  • Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
  • It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study.
  • Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites.
  • Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s).
  • Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents.
  • Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
  • Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations
  • Coaching, counseling, and disciplining the employees as applicable.
  • To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
  • Communicating and effective implementation of strategic goals from senior management to the site team.
  • Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
  • Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s).
  • Being prepared for and available at all required company meetings.
  • Submitting required administrative paperwork per company timelines.
  • Occasionally attending out-of-town Investigator Meetings.
  • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
  • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
  • Facilitate effective communication between patients, healthcare providers, and research staff
  • Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:

  • Bachelor’s degree preferred
  • Advanced degree preferred

Experience:

  • At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization.

Credentials:

  • Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.

Knowledge and Skills:

  • Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail.
  • Critical Thinking
  • Active Listening
  • Reading Comprehension — Understanding written sentences and paragraphs in work-related documents.
  • Speaking and Writing to communicate effectively as appropriate for the needs of the audience.
  • Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.
  • Strong computer skills in relevant software and related clinical systems are required.
  • Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
  • Proficient communication and comprehension skills both verbal and written in the English language are required.
  • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.


  • Boston, Massachusetts, United States Sleeping Dog Properties Full time

    Job DescriptionWe are seeking a skilled Site Supervisor to provide on-site coordination for all phases of construction projects, including coordinating subcontractors, material and equipment, ensuring that specifications are being strictly followed, and work is proceeding on schedule and within budget.The ideal candidate will be responsible for scheduling,...

  • Site Manager

    4 weeks ago


    Boston, Massachusetts, United States STP Full time

    Job Summary:We are seeking a highly skilled Site Manager to oversee the execution of our construction projects in the Worcester, MA area. The ideal candidate will have a strong background in concrete construction and excellent leadership skills.Key Responsibilities:* Manage lead personnel and staff to ensure projects are completed on time and within budget*...


  • Boston, United States Action For Boston Community Development Full time

    Community Site ManagerDepartment: Community Coordination Employment Type: Permanent - Full Time Location: South End Description Community Coordination handles direct case management services to clients currently at or below 200% of the Federal Poverty Line who live in Boston, Malden, Medford, and Everett. Join us as a Community Site Manager in creating a...


  • Boston, Massachusetts, United States Klaviyo Full time

    Klaviyo is committed to empowering creators to own their destiny by making first-party data accessible and actionable like never before. To achieve this goal, we need a talented Site Reliability Engineering Manager to join our team.The Site Reliability Engineering Manager will be responsible for leading a team of Site Reliability Engineers in Klaviyo's...


  • Boston, United States Adecco USA Full time

    Exciting Opportunity: Legal Firm Site Manager Join a dynamic team in the heart of Boston! We're seeking a Site Manager to oversee daily operations at a prestigious law firm, leading a talented staff dedicated to delivering exceptional hospitality and office services.Key Responsibilities:Act as the main liaison between our team and the client's...


  • Boston, Massachusetts, United States brightview Full time

    At BrightView, we're passionate about delivering exceptional results and fostering a supportive environment for our team members to thrive.Key Responsibilities:Oversee field operations for commercial site development projects from inception to completion.Manage multiple projects simultaneously, ensuring timely completion and high-quality...

  • Site Safety Manager

    4 weeks ago


    Boston, Massachusetts, United States Steel Erectors Association Full time

    This is a 1099 position for a 1-year commitment as a site safety manager in Massachusetts.You will be representing a top Structural Steel Erection Company on this project.The project needs someone to start immediately.The pay is $45 an hour straight time, time and a half for overtime (over 40 hrs), and double time for Sunday's and major holiday's worked.This...

  • Community Site Manager

    3 months ago


    East Boston, United States Action for Boston Community Development, Inc., (ABCD) Full time $30

    We are hiring Site Managers at the following locations:East BostonSouth EndCommunity Coordination handles direct case management services to clients currently at or below 200% of the Federal Poverty Line who live in Boston, Malden, Medford, and Everett. Join us as a Community Site Manager in creating a supportive and enriching environment for our community....


  • Boston, Massachusetts, United States Geeks on Site Full time

    Job OverviewAbout Geeks On Site:We are a leading provider of technology services, specializing in home and business solutions. Our team is dedicated to delivering exceptional customer service and high-quality technical support.Position Summary:As a TV Mounting Technician at Geeks On Site, you will be responsible for providing professional and efficient TV...

  • Site Specialist

    4 weeks ago


    Boston, Massachusetts, United States Thermo Fisher Scientific Full time

    Job Title: Sr. Site Specialist (Chemical Inventory)This role is located in Boston, MA, and focuses on service delivery quality for Unity Lab Services, a division of Thermo Fisher responsible for providing onsite services at customers' locations.We provide services at over 400 customer sites globally. The successful candidate will be responsible...


  • Boston, United States Commonwealth Care Alliance Full time

    Why This Role is Important to Us: CCA partners with the Commonwealth of Massachusetts to provide supportive temporary emergency shelter to families under the Executive Office of Housing and Livable Communities' Emergency Assistance program. Our shelter program is part of the Commonwealth's response to a rapidly growing number of unhoused families, including...


  • Boston, Massachusetts, United States Tufts Medicine Full time

    Job DescriptionTufts Medicine is seeking a highly skilled and experienced Executive Site Director IT to lead our Information Services team. As a critical role at Tufts Medical Center, this position will be responsible for overseeing the development and implementation of technology infrastructure, information system assets, and telecommunications for the...


  • Boston, United States Network Building + Consulting Full time

    The Site Acquisition Specialist will work independently and contribute to the project team with advanced degrees of direct and indirect project responsibilities utilizing a fully developed knowledgebase of the telecommunications site development process. Project work will focus on new site development of macro and small cell sites, the modification of...


  • boston, United States Network Building + Consulting Full time

    The Site Acquisition Specialist will work independently and contribute to the project team with advanced degrees of direct and indirect project responsibilities utilizing a fully developed knowledgebase of the telecommunications site development process. Project work will focus on new site development of macro and small cell sites, the modification of...


  • Boston, Massachusetts, United States Mass General Brigham Full time

    Job DescriptionThe Sr. Project Manager of the Research Site is responsible for overseeing all operational aspects of the TIMI local MGB/BWH Clinical Research Site. This position reports directly to the TIMI Director of Operations and the TIMI Research Site Physician Director.Key ResponsibilitiesCollaborate with TIMI Principal Investigators (PIs) and study...

  • Project Manager

    1 month ago


    Boston, Massachusetts, United States LJV Development Full time

    Job OverviewLJV Development LLC is seeking an experienced Project Manager to lead our construction projects from concept to completion. As a key member of our team, you will be responsible for overseeing project schedules, finances, and ensuring a safe and efficient worksite.Key Responsibilities:Develop and manage project schedules, budgets, and resource...


  • Boston, Massachusetts, United States Action for Boston Community Development, Inc., (ABCD) Full time

    Community Site ManagerWe are seeking a highly skilled and experienced Community Site Manager to join our team at Action for Boston Community Development, Inc., (ABCD). As a Community Site Manager, you will be responsible for overseeing the daily operations of a Community Coordination Site, ensuring that program activities and performance meet and exceed...

  • Site Superintendent

    4 months ago


    Boston, United States brightview.com Full time

    At BrightView, the best teams are created and maintained here. If you are searching for your next fulfilling career, picture yourself on a best-in-class team where you can grow to be your brightest. We’re looking for a Site Superintendent. Can you picture yourself here? You’d be responsible for: Managing field operations for commercial site development...


  • Boston, Massachusetts, United States Tufts Corporate Full time

    About the RoleTufts Corporate is seeking an experienced Executive Site Director IT to lead our Information Services team. As a critical role at Tufts Corporate, you will be responsible for developing and implementing a plan that addresses governance, system-wide IS strategies, goals, and objectives.Key ResponsibilitiesLead Information Services to support the...

  • Site Supervisor

    3 weeks ago


    Boston, United States Chenega Full time

    SummaryJoin our team! The Site Supervisor oversees guard force personnel at the assigned respective location.This position is contingent upon award and not currently funded. ResponsibilitiesWhat You'll Get To Do:Manage and supervise Shift Supervisors and hourly staff, ensuring compliant execution of access control, visitor support, alarm response, and...