Clinical Research Coordinator II; Frederick​/Germantown

Overview

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 $58,798 -$77,435. 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.

Responsible for recruiting, screening, consenting and enrolling patients in clinical trials. CRC II also coordinates and oversees the subject’s visits in accordance with the protocol requirements. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers. Acts as resource for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs.

Compiles and reports protocol activity; accrual data, and financial information. 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.

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
• Coordinates patient care in compliance with protocol requirements. May disburse investigational drug. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Packages and ships lab specimens to central vendors where applicable. Required to complete Hazmat and or IATA training.
• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
• Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents and annual continuing review reports.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite. May collaborate with Research Site Leader in the study selection process.
• Participates in required training and education programs. May be responsible for education of clinic staff regarding clinical research. Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality.
• May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians. May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum three years of experience in a clinical or scientific related discipline required, preferably in oncology.
• SoCRA or ACRP certification preferred.

• Experience in Microsoft Office
• Experience working with physicians preferred
• Experience working in clinical research is preferred

• Must have excellent communication skills
• Excellent organizational 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
• May be responsible for basic clinical assessments

Environment (Office, warehouse, etc.) -

• Traditional 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 will be offered to enable individuals with disabilities to perform the essential functions. Exposure to…