Clinical Research Coordinator

7 days ago

Bethesda, Maryland, United States Guidehouse Full time

Job Family
:
Patient Care Coordinator (Digital)

Travel Required
:
None

Clearance Required
:
Ability to Obtain Public Trust

What You Will Do
:
​​We are currently searching for a Clinical Research Coordinator to provide clinical research coordination and protocol navigation for the NINDS Intramural Research Program. This is a full-time, on-site opportunity in Bethesda, MD.

  • Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates, and practices.
  • Prepare and submit accurate source documents related to all research procedures for review.
  • Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields.
  • Enter data into research databases, systems, and applications for ongoing studies.
  • Assist researchers with study testing, observations data entry and other duties associated with study sessions.
  • Assist researchers in collecting, organizing, and maintaining accurate records of all protocols and study applications, investigator qualifications, study logs, safety reports, annual reports, and correspondence.
  • Work with staff on the design, development, and preparation of documents such as CRFs, spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries.
  • Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
  • Adhere to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
  • Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • Work with investigators to assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.
  • Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
  • Document, collect, record, and retain all research related participant encounters including in person, phone, or electronic in the research record e.g., source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
  • Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.
  • Research changes and updates to Good Clinical Practices (GCP) and prepare summaries, job aids and training materials for research staff and new clinical research coordinators. ​​

What You Will Need
:

  • Bachelor's degree
  • At least four (4) years of clinical research experience.
  • Experience with electronic systems such as Clinical Trial Management System (CTMS), Electronic Medical Records System, or Electronic Data Capture System

What Would Be Nice To Have
:

  • Professional certification highly desired specifically from one of the following organizations Association of Clinical Research Professionals Certified Professional (ACRP-CP); Association of Clinical Research Professionals (ACRP); Certified Clinical Research Professional (CCRP); Certified Clinical Research Coordinator (CCRC); Certified Clinical Research Associate (CCRA).
  • Oversee and document IP dispensing, inventory, and reconciliation.
  • Close clinical trial sites down on completion of clinical trial.
  • Order tracking, managing IP and trial materials.
  • Implementation of clinical trial site action plans.
  • Train clinical trial site staff.
  • Coordinate project meetings and monitor remote sites.
  • Previous clinical research or trial work, specifically Phase I or II experience.
  • Electronic medical records.
  • Protocol development, review, revision, and navigation.
  • Maintain patient confidentiality and regulatory compliance.
  • Data Monitoring and Integrity.
  • Recruitment, scheduling, and screening of study participants.
  • Liaise with regulatory authorities and the ethic committee.
  • Oversee regulatory affairs and IRB submissions.

What We Offer:


Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.


Benefits include:

  • Medical, Rx, Dental & Vision Insurance
  • Personal and Family Sick Time & Company Paid Holidays
  • Parental Leave
  • 401(k) Retirement Plan
  • Group Term Life and Travel Assistance
  • Voluntary Life and AD&D Insurance
  • Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
  • Transit and Parking Commuter Benefits
  • Short-Term & Long-Term Disability
  • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
  • Employee Referral Program
  • Corporate Sponsored Events & Community Outreach
  • annual membership
  • Employee Assistance Program
  • Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
  • Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.


Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.


If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at or via email at .

All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

_Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies.

All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

_

  • Clinical Research Nurse III

    2 weeks ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Clinical Research Nurse III - Center for Immuno-Oncology (CIO)Job ID: req3973Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute...

  • Patient Care Coordinator III

    7 days ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Patient Care Coordinator III - hybridJob ID: req3950Employee Type: nonexempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and...

  • Patient Care Coordinator III

    1 day ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Patient Care Coordinator III - hybridJob ID: req3950Employee Type: nonexempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and...

  • Lasker Clinical Research Scholars

    3 weeks ago

    Bethesda, Maryland, United States NIHODOIR Full time

    The National Institutes of Health is RecruitingLasker Clinical Research ScholarsThe National Institutes of Health, in partnership with the Lasker Foundation, is pleased to announce the 2024 Lasker Clinical Research Scholars Program. This is an opportunity for up to 10 years of funding for clinical researchers.The Lasker Scholars program supports a small...

  • ACUC Coordinator

    4 weeks ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    ACUC CoordinatorJob ID: req3936Employee Type: exempt full-timeDivision: Laboratory Animal Science ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical...

  • ACUC Coordinator

    3 weeks ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    ACUC CoordinatorJob ID: req3936Employee Type: exempt full-timeDivision: Laboratory Animal Science ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical...

  • Clinical Research Assistant I

    7 days ago

    Bethesda, Maryland, United States The Henry M. Jackson Foundation for the Advancement of Military Medicine Full time

    Overview:Join the HJF TeamThis position will be in support of the research portfolios of the Center for Deployment Psychology and the Department of Medical and Clinical Psychology at the Uniformed Services University of the Health Sciences in Bethesda, MD.The Research Assistant will support the Uniformed Services University of the Health Sciences' Department...

  • Assistant Clinical Investigators Transition Program in Clinical Research

    4 weeks ago

    Bethesda, Maryland, United States National Institute of Allergy & Infectious Diseases, NIAID Full time

    The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes at the National Institutes of Health (NIH) and part of the Department of Health and Human Services (HHS), conducts and supports a global program of research to better understand treat, and ultimately prevent infectious, immunologic, and allergic diseases. The...

  • Assistant Clinical Investigators Transition Program in Clinical Research

    3 weeks ago

    Bethesda, Maryland, United States National Institute of Allergy & Infectious Diseases, NIAID Full time

    The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes at the National Institutes of Health (NIH) and part of the Department of Health and Human Services (HHS), conducts and supports a global program of research to better understand treat, and ultimately prevent infectious, immunologic, and allergic diseases. The...

  • Research Associate II, Single Cell Analysis Facility

    7 days ago

    Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Research Associate II, Single Cell Analysis Facility Job ID: req3966 Employee Type: exempt full-time Division: Cancer Research Technology Program Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer...

  • Clinical Communications Coordinator

    7 days ago

    Bethesda, Maryland, United States Cystic Fibrosis Foundation Full time

    The Cystic Fibrosis Foundation is a leading healthcare nonprofit organization like no other. For decades, we have been taking major steps and pioneering new ways to advance the mission to find a cure for cystic fibrosis and to provide all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, partnering with...

  • Clinical Neuropsychologist

    7 days ago

    Bethesda, Maryland, United States Akahi Associates, LLC Full time

    Position Title: Clinical Neuropsychologist Company: National Institute of Mental Health Salary: Starting at $110,000/year Job Overview: If you're passionate about providing support services in the field of neuropsychology, we have a fantastic opportunity for you. As a Clinical Neuropsychologist at NIMH in Rockville, MD, you will play a key role in conducting...

  • Clinical Director

    3 weeks ago

    Bethesda, Maryland, United States National Heart Lung and Blood Institute, NIH Full time

    THE POSITION: The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) is seeking exceptional candidates for the position of Clinical Director to provide leadership in one of the preeminent Institutes. The NHLBI's mission is to provide global leadership for a research, training, and education program to promote the...

  • Clinical Regulatory and Operations Specialist

    7 days ago

    Bethesda, Maryland, United States American Society for Virology Full time

    Jobs in Virology by ASV - Clinical Regulatory and Operations Specialist Clinical Regulatory and Operations Specialist National Institute of Allergy and Infectious Disease Tweet Apply Bookmark Report Categories:OtherJob Type/Arrangement:Full TimeDescription:Division of Clinical ResearchCollaborative Clinical Research BranchThe National Institute of Allergy...

  • Clinical Advisor

    3 weeks ago

    Bethesda, Maryland, United States CAMRIS International, LLC Full time

    OverviewWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with...

  • Clinical Advisor

    1 month ago

    Bethesda, Maryland, United States CAMRIS International, LLC Full time

    OverviewWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with...

  • Patient Care Coordinator III

    7 days ago

    Bethesda, Maryland, United States BioSpace, Inc. Full time

    Job DetailsPatient Care Coordinator III - hybridJob ID: req3950Employee Type: nonexempt full-timeDivision: Clinical Monitoring Research ProgramFacility:NIHLocation:NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute...

  • Clinical Advisor

    3 weeks ago

    Bethesda, Maryland, United States CAMRIS International, LLC Full time

    OverviewWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with...

  • Clinical Advisor

    1 month ago

    Bethesda, Maryland, United States CAMRIS International, LLC Full time

    OverviewWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with...

  • Clinical Director, NHLBI

    3 weeks ago

    Bethesda, Maryland, United States National Heart, Lung, and Blood Institute Full time

    Department of Health and Human ServicesNational Institutes of HealthClinical Director, NHLBITHE POSITION: The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) is seeking exceptional candidates for the position of Clinical Director to provide leadership in one of the preeminent Institutes. The NHLBI's mission is to...