Clinical Research Associate jobs in New Haven, CT

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Manager / Associate, Grants and Contracts
  • Advanced Clinical
  • Branford, CT FULL_TIME
  • Overview

    The Manager/Associate of Grants and Contracts (MGC) plays a key role in advancing critical activities within the Clinical Development team and will report to the Sr. Manager, Grants and Contracts.

    Responsibilities

    • Independently negotiates initial or amended site Clinical Trial Agreements (CTAs) and budgets, and/or serves as escalation point and oversight for CROs negotiating site CTAs and budgets in support of assigned global Clinical Studies.
    • Independently negotiates other initial or amended clinical Agreements such as Investigator Initiated Research Agreements (IIRs), Confidential Disclosure Agreements (CDAs), Consulting Agreements, as well as Vendor Agreements such as Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs).
    • Ensures appropriate Data Privacy language is included in applicable ex-US contracts per GDPR guidance
    • Oversees CRO development and review/approval of country-specific site CTA and budget templates
    • Liaises with legal, manager, and study team members as necessary to ensure contracts and budgets are finalized, executed, logged and filed in accordance with Celldex standards and within the timeline needed to meet key company milestones
    • Tracks ongoing projects and maintains supporting documentation for MGC role
    • Gathers, populates, and oversees the review of monthly accrual data for assigned clinical studies and liaises with Clinical Operations and Finance to ensure accurate financial reporting with supporting documentation. Delivers rationale for study-specific approaches in collaboration with team.
    • Attends meetings with finance, clinical operations, study teams, CROs, manager, and other internal or external parties to ensure full understanding of assignments including overall timelines and deliverables. Represents grants and contracts function as assigned and provides status updates, notes any gaps in contractual coverage or new items needed based on project status or changes. Tracks any MGC action items and moves them forward until completion.
    • May assist manager with review of internal contract or budget templates or MGC processes and provide input as requested
    • May assist clinical team in vendor selection/RFP process
    • May be responsible for populating site payment data for studies not outsourced to a CRO, and/or reconciling internally or externally managed final site payments

    Qualifications

    • At least 1 year relevant experience directly negotiating clinical site and vendor contracts, experience negotiating ex-US contracts a plus
    • 3 years in a clinical development or clinical operations team with a pharmaceutical company, CRO, or investigator site
    • Understanding of healthcare compliance and other relevant guidance including GCP, HIPAA, FCPA
    • Experience with EU GDPR guidance and managing data privacy terms a plus
    • Bachelor's Degree required, Juris Doctorate or paralegal a plus
    • A combination of experience and education may be substituted
    • Experience will determine level (MGC or Assoc. MGC)
    • Strong Microsoft skills including Word, Excel, Teams, and Sharepoint
    • Ability to review tracked changes and comments from multiple reviewers within a document and collate/ combine feedback, rewording as appropriate before returning to external parties
    • Ability to manage a high volume workload independently and the agility to prioritize more urgent tasks based on project timelines, company goals, and manager directives

    About Advanced Clinical
    Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

    Regarding your application
    Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

    It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

  • 20 Days Ago

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Clinical Research Unit - Research Physician
  • System One
  • New Haven, CT CONTRACTOR
  • Title: Research Physician Location: MUST be local to CT. Will not consider remote work Type: Contract Start Date: ASAP Leading Pharmaceutical Company located in CT is hiring a Research Physician w/ 3 ...
  • 16 Days Ago

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Clinical Research Nursing Provider
  • Pfizer
  • New Haven, CT FULL_TIME
  • Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compl...
  • 2 Days Ago

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Clinical Research Regulatory Manager
  • Inclusively
  • New Haven, CT FULL_TIME
  • Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Clinical Research Regulatory Manager.ABOUT INCLUSIVELY:Inclusively is a digital tech platform that connects cand...
  • 9 Days Ago

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Clinical Research Specialist
  • Integrated Resources INC
  • New Haven, CT FULL_TIME
  • Company DescriptionIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business m...
  • 14 Days Ago

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Remote Clinical Research Specialist
  • Integrated Resources INC
  • New Haven, CT FULL_TIME
  • Company DescriptionIntegrated 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 ...
  • 14 Days Ago

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0 Clinical Research Associate jobs found in New Haven, CT area

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Clinical Research Associate
  • McInnis Inc.
  • Ridgefield, CT
  • The Clinical Research Associate will support clinical research activities within research sites that are actively partic...
  • 3/28/2024 12:00:00 AM

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Clinical Research Coordinator 2
  • Yale University
  • New Haven, CT
  • Essential Duties 1. Serves as the primary oversight specialist on clinical and operational processes for moderately to h...
  • 3/28/2024 12:00:00 AM

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Site Monitoring Lead - REMOTE
  • Sierra Solutions Group
  • Ridgefield, CT
  • Job Summary We are looking for an Site Monitoring Lead for our Pharmaceutical client located on the East Coast. Primary ...
  • 3/28/2024 12:00:00 AM

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Clinical Research- Registered Nurse
  • Yale-New Haven Health
  • Bridgeport, CT
  • Overview To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mis...
  • 3/28/2024 12:00:00 AM

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Clinical Research- Registered Nurse
  • Yale New Haven Health
  • Bridgeport, CT
  • Overview: To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mi...
  • 3/28/2024 12:00:00 AM

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Senior Clinical Research Associate(Future Opportunities)
  • Alexion Pharmaceuticals, Inc.
  • New Haven, CT
  • This is what you will do: The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of ...
  • 3/27/2024 12:00:00 AM

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Remote Clinical Research Specialist
  • Careerbuilder
  • New Haven, CT
  • Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professiona...
  • 3/25/2024 12:00:00 AM

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Logistics Associate - Commack
  • Memorial Sloan-Kettering Cancer Center
  • Commack, NY
  • The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our...
  • 3/24/2024 12:00:00 AM

New Haven is a coastal city in the U.S. state of Connecticut. It is located on New Haven Harbor on the northern shore of Long Island Sound in New Haven County, Connecticut, and is part of the New York metropolitan area. With a population of 129,779 as determined by the 2010 United States Census, it is the second-largest city in Connecticut after Bridgeport. New Haven is the principal municipality of Greater New Haven, which had a total population of 862,477 in 2010. New Haven was the first planned city in America. A year after its founding by English Puritans in 1638, eight streets were laid o...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Associate jobs
$73,846 to $97,543
New Haven, Connecticut area prices
were up 1.7% from a year ago

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Meet with staff on an annual basis to develop and implement career goals in order to encourage and promote professional growth and development.
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