Clinical Laboratory Study Manager

4 days ago

Washington, Washington, D.C., United States Parexel Full time

Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy.

Operations Management

Study Team Support

  • Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing

Operational Support of Sample Analysis (including exploratory analysis)

  • Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations
  • Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans

Data Acquisition and Management

  • Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials

Human Sample Management Flow and Compliance

  • Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects
  • Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF
  • Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed

Compliance with Parexel Standards

  • Complies with required training curriculum
  • Completes timesheets accurately as required
  • Submits expense reports as required
  • Updates CV as required
  • Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery

Skills:

  • Excellent written and verbal communication skills
  • Resolve problems spontaneously and possess strong project management and organizational skills
  • Work independently and proactively while still contributing to group initiatives and goals
  • Good interpersonal skills and ability to work with many different groups/teams
  • Microsoft applications

Knowledge and Experience:

6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases. Laboratory sample management experience is a plus.

Education:

Bachelor's degree in a life science, nursing qualification or other relevant experience required.

LI-LO1
LI-REMOTE

  • Clinical Research Assistant

    1 week ago

    Washington, Washington, D.C., United States Children's National Hospital Full time

    The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research...

  • Clinical Research Assistant

    6 days ago

    Washington, Washington, D.C., United States Children's National Hospital Full time

    The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research...

  • Medical Laboratory Scientist III

    1 week ago

    Washington, Washington, D.C., United States MedStar Health Full time

    General Summary of PositionPerforms routine and specialized assays and provides technical advice and information in one or more of several clinical laboratory scientific specialties to provide data for use in the diagnosis and treatment of diseases. Analyzes body fluids, cells and products to identify abnormal and critical disorders associated with disease...

  • Clinical Operations Leader

    4 days ago

    Washington, Washington, D.C., United States Parexel Full time

    Job Summary:The Clinical Operations Leader is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting,...

  • APRN Clinic

    3 days ago

    Washington, Washington, D.C., United States American Oncology Network Full time

    Location:Greater Washington Oncology AssociatesPay Range:$80, $170,000.00This position supports Greater Washington Oncology Associates in DC and Silver Spring, MD.Position SummaryAssists physician in the care and teaching of patients.Key Performance AreasAssess the physical and psychosocial status of patients by means of interview, health history, physical...

  • Clinical Trial Associate

    3 days ago

    Washington, Washington, D.C., United States IQVIA Full time $47,400 - $118,600

    MCRA, an IQVIA business is seeking a strong In-House CRA to join our Clinical team. The In-House Clinical Research Associate will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele. Position OverviewThe Clinical Trial Associate (CTA) supports the In-House Clinical...

  • Clinical Quality Consultant

    4 days ago

    Washington, Washington, D.C., United States Michelle Kusowski Consulting, LLC Full time

    Company DescriptionMichelle Kusowski Consulting, LLC specializes in providing practical, scalable, and regulatory-aligned solutions for clinical quality management. The company offers expertise in areas such as GCP quality consulting, inspection readiness, vendor and CRO oversight, and risk-based quality management. Partnering with organizations, they...

  • APRN Clinic

    2 weeks ago

    Washington, Washington, D.C., United States American Oncology Network Full time $80,000 - $170,000

    Location:Greater Washington Oncology AssociatesPay Range:$80, $170,000.00 This position supports Greater Washington Oncology Associates in DC and Silver Spring, MD.Position SummaryAssists physician in the care and teaching of patients.Key Performance AreasAssess the physical and psychosocial status of patients by means of interview, health history, physical...

  • Primary Care and Family Practice Clinic Physician MD

    14 hours ago

    Washington, Washington, D.C., United States Clinical Management Consultants Full time

    Primary Care and Family Practice Clinic Physician MD — Thrive in a high-growth, patient-centered outpatient setting The Primary Care and Family Practice Clinic Physician MD will join a mission-driven healthcare organization delivering exceptional primary care and family medicine to a grateful community.Primary Care and Family Practice Clinic Physician MD...

  • Phlebotomist/Processing Assistant, Evenings, Laboratory Services

    10 hours ago

    Washington, Washington, D.C., United States Howard University Hospital Full time

    With over 150 years of caring for our community and each other in the Washington DC area, Howard University Hospital has a world-renowned reputation for high-quality, patient-centric care. Howard University Hospital is the nation's only teaching hospital located on the campus of a Historically Black University and has created a superior learning environment,...