Project Manager

Guidehouse•Bethesda, MD

12d•$98,000 - $163,000•Onsite

About The Position

We are currently searching for Clinical Research Coordinator to independently contribute to satisfying the overall operational objectives of the National Heart, Lung, and Blood Institute (NHLBI) through the provision of services and deliverables. This is a full-time, on-site opportunity in Bethesda, MD. Ensure the study is compliant with local and federal laws and regulations. Collaborate with the Principal Investigator (PI) and other team members in the management of protocols from study inception to close-out as well as in the preparation and submission of regulatory reports. Recruit and screen potential study participants, perform intake assessments, and obtain informed consent for non-treatment clinical trials (screening, natural history, and observational trials). Act as a point of reference for study participants by answering questions and keeping them informed on the study progress. Ensure all protocol required testing and patient visits are scheduled in accordance with protocol guidelines including the timely scheduling of patients for appointments/testing and the careful acquisition and distribution of clinical samples. Create and/or maintain all documents and records related to the study, including documenting all patient encounters in the legal medical record and other areas as required by the Institution. Obtain documents from outside providers/laboratories needed as part of the research data. Assess documentation for discrepancies; ensure inaccurate or inconsistent information is addressed in the medical record or other source documents. Participate in office and branch activities to improve documentation. Manage the inventory of equipment and supplies related to the study; place orders as needed according to the standard operating procedures. Draft reports on each study, including notes on protocols, workload, and data collection. Collaborate with data management to ensure the quality of data captured in electronic data capture systems.

Requirements

Master’s degree.
At least SEVEN (7) years of clinical research experience.
Demonstrated proficiency using Microsoft Office 365, electronic medical records and/or electronic data capture systems.
Proven understanding of medical terminology as well as standard clinical procedures and protocols.
Possess a working knowledge of good clinical practices and federal regulations for the implementation of clinical trials.
Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse.
Candidates with an active public trust or suitability are preferred

Nice To Haves

Excellent organizational, time-management, and written/verbal communication skills.
Able to work independently with minimal supervision and as part of a team.
Able to lift a maximum of 20 pounds for short periods.
Able to stand for extended periods of time.

Responsibilities

Ensure the study is compliant with local and federal laws and regulations.
Collaborate with the Principal Investigator (PI) and other team members in the management of protocols from study inception to close-out as well as in the preparation and submission of regulatory reports.
Recruit and screen potential study participants, perform intake assessments, and obtain informed consent for non-treatment clinical trials (screening, natural history, and observational trials).
Act as a point of reference for study participants by answering questions and keeping them informed on the study progress.
Ensure all protocol required testing and patient visits are scheduled in accordance with protocol guidelines including the timely scheduling of patients for appointments/testing and the careful acquisition and distribution of clinical samples.
Create and/or maintain all documents and records related to the study, including documenting all patient encounters in the legal medical record and other areas as required by the Institution.
Obtain documents from outside providers/laboratories needed as part of the research data.
Assess documentation for discrepancies; ensure inaccurate or inconsistent information is addressed in the medical record or other source documents.
Participate in office and branch activities to improve documentation.
Manage the inventory of equipment and supplies related to the study; place orders as needed according to the standard operating procedures.
Draft reports on each study, including notes on protocols, workload, and data collection.
Collaborate with data management to ensure the quality of data captured in electronic data capture systems.

Benefits

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
Care.com 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