Regulatory Coordinator - I ( Onsite Calverton )
Maryland Oncology
Beltsville, Maryland
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JOB DETAILS
SALARY
$26.02–$40.03 Per Hour
SKILLS
Cancer, Centers for Disease Control and Prevention (CDC), Clinical Practices/Protocols, Clinical Research, Clinical Trial, Communication Skills, Detail Oriented, FDA Requirements, Federal Laws and Regulations, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Hearing Impairment, Hematology, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Infectious Diseases, Informed Consent, Interpersonal Skills, Lift/Move 40 Pounds, OSHA, Oncology, Organizational Skills, People Management, Physical Demands, Regulations, Regulatory Compliance, Regulatory Submissions, Research Administration, Standard Operating Procedures (SOP), Startup, State Laws and Regulations, Time Management
LOCATION
Beltsville, Maryland
POSTED
16 days ago
Join Our Team at Maryland Oncology Hematology!
We’re looking for passionate and talented professionals to join our team in providing exceptional cancer care. If you’re dedicated to making a difference for patients, physicians, and colleagues, we want to hear from you! With 15+ locations across Maryland and DC, we offer a dynamic and supportive environment where you can grow and thrive.
Explore opportunities with us and apply today!
The general pay scale for this position at MOH is $26.02 - $40.03 per hour. The actual hiring rate is dependent on many factors, including but not limited to prior work experience, education, job/position responsibilities, location, work performance, etc.
Job Profile Summary
Under general supervision is responsible for supporting the regulatory team with coordinating the research regulatory and administrative activities of clinical trials for the practice. Coordinates the preparation of regulatory submissions for new and continuing review of clinical trials. Works closely with US Oncology Regulatory and Sponsors in coordination of study start-up and closure procedures. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
Job Description
Key Responsibilities
Coordinates Critical Document Collection to facilitate the timely opening of trials at the site.
Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures. Reviews Investigator files and verifies all regulatory documents are filed in accordance with federal, state, and local regulations.
Assists with scheduling for monitoring visits, study start up visits, close out visits, and audits as needed. Communicates issues with regulatory documents or procedures to clinical staff, research management, and investigators.
Assists with preparation of Informed Consent Documents and creates regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions. Coordinates local and central Institutional Review Board submissions.
Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
May compile information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.
Minimum Job Qualifications (Knowledge, Skills, & Abilities):
Education/Training -
High school diploma or equivalent required; some college coursework or other relevant background preferred
Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required
Business Experience -
Experience in Microsoft Office
Experience working with Sponsor Monitor representatives
Specialized Knowledge/Skills -
Experience working in clinical research is preferred
Must have excellent communication skills
Strong ability to multi-task
Excellent time management skills
Must have strong interpersonal skills to be able to interact with multiple people on many different levels
Must have a high level of attention to detail
Must be able to work in a fast paced environment
Working Conditions:
Environment (Office, warehouse, etc.) –
Traditional outpatient clinic/office environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an
oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.) –
Large percent of time performing computer based work is required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
(This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)
About the Company
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