Clinical Study Coordinator II

Job ID: req3992

Employee Type: exempt full-time

Division: Clinical Monitoring Research Program

Facility: Telework: US

Location: USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

Program Description

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides strategic, operational, and program/project management support to domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and various other institutes within the National Institutes of Health (NIH). CMRPD’s services are strategically aligned with the mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD manages research initiatives and supports clinical trials that investigate the prevention, diagnosis, and therapeutic treatment of cancer, influenza, HIV, and other diseases and disorders.

CMRPD is providing support to NCI’s Division of Cancer Treatment and Diagnosis (DCTD) Virtual Clinical Trials Office (VCTO) pilot. The pilot aims to determine if participant enrollment to NCI clinical trials, particularly for minority and underserved populations, can be improved by establishing a team of remote clinical research support staff. This team provides centralized, virtual support to U.S. NCI research sites, including sites participating in the NCI Community Oncology Research Program (NCORP). The remote support team will supplement and compliment the clinical site staff at NCI research sites to offset clinical trial activities, such as subject screening, enrollment, and data entry.

Key Roles/Responsibilities

Provide remote study coordination support to an assigned caseload of research protocols. This is not a monitoring role. Duties include, but are not limited to:

• Protocol Coordination 
• Prepares regulatory and protocol-specific documents
• Tracks and manages IRB submissions
• Reviews study protocols and assist in the planning, implementation, and close-out phases of study protocols. Examples of associated tasks:
• Sets up electronic regulatory binders
• Develops study-specific forms and processes
• Assist with participant coordination activities (e.g., scheduling visits, performing protocol defined long-term follow-up assessments)
• Reviews medical records to correctly identify con-meds and AEs/unanticipated problem/SAEs
• Maintain con-meds and AEs lists
• Report SAEs in a timely manner
• Track and assist with follow-up AE/SAE reporting requirements and close-out procedures
• Works with the study team and regulatory monitors to monitor participant safety and protocol endpoints by:
• Reviewing protocol data accuracy and completeness
• Monitoring protocol compliance with Good Clinical Practice (GCP), site-specific standard procedures, and applicable FDA regulations
• Patient Identification, Screening, and Enrollment
• Communicates with participants and referring providers about the screening and enrollment process
• Facilitates the procurement and review of potential participants’ medical records and materials for the purpose of screening to determine participant eligibility
• Reviews participant materials to appropriately advise local teams on potential participant eligibility for protocols
• Assists with the informed consent process
• Documents screening and enrollment activities in appropriate databases (such as, NCI Oncology Patient Enrollment Network system, also known as OPEN; internal tracking files)
• Data Management
• Completes the collection and entry of research participant data and study-related information sourced from the Electronic Health Record (e.g., Epic, Cerner, etc.) into electronic clinical data capturing systems (e.g., eCRFs, Medidata Rave, REDCap, etc.) and clinical trial management systems (e.g., OnCore, Florence e-Reg, Velos eResearch, Complion, etc.) in a timely and accurate manner, to ensure data integrity
• Tracks and confirms source materials (e.g., images, path, etc.) and submits for protocol-defined processing
• Files and maintains records in accordance with protocol and site-specific guidance
• Evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of clinical trial participant data
• Collaborates with local site staff and remote VCTO team members to resolve queries to meet protocol requirements in an efficient and effective manner
• Alerts site study teams to adverse events, abnormal outcomes, or problematic trends, specifically regarding protocol requirements
• Collaboration
• Works collaboratively with VCTO team members, site staff, and data monitors to meet program and protocol requirements, deadlines, and deliverables
• Updates and maintains tracking tools to ensure protocol and program milestones are met in a timely manner
• Effectively tracks and accurately presents the status of assigned tasks at team meetings and other reporting periods
• Participates in virtual/online meetings with the clinical care teams at various clinical sites to review clinical research protocols, procedures, and reports
• This position is 100% remote. Candidates must reside in the U.S. or a U.S. territory
  

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Knowledge

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• Intermediate technical knowledge and understanding of:
• Biological principles and scientific methods.
• International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, regulatory, ethics, processes, and clinical protocol implementation.
• Cancer pathophysiology, treatment modalities and side effects.
  

Skills/Experience

• In addition to the education requirement, a minimum of two (2) years of progressively responsible, relevant study coordination experience in clinical research, including directly managing multiple concurrent projects and a study team
• Competency with:
• Cloud–based clinical trial data management systems (e.g., Medidata Rave) and enrollment tracking systems (e.g., OPEN)
• Electronic health record systems (e.g., Epic, Cerner, etc.)
• Microsoft Office products (e.g., Excel, Word, etc.)
• Online/virtual platforms (e.g., Webex, Zoom, Microsoft Teams)
• Highly effective:
• Interpersonal and cross-cultural communication skills (e.g., written, verbal, non-verbal, and virtual)
• Organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detail
• Planning, and problem-solving skills
• Computer skills
  

Additional Role-specific Requirements

• Ability to work effectively, both independently and collaboratively, with team members to track work progress, and contribute to the team’s performance
• Identify trends and appropriately escalate findings
• Demonstrate strong initiative, accountability, and reliability
• Multidirectional leadership
• Manage customer relationships
• Independently troubleshoot basic IT problems
• Ability to obtain and maintain a security clearance
  
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

Prior Experience With

• Clinical oncology
• NCTN/ECTN trials
• Performing user acceptance trainings
• Epic, OPEN, Medidata Rave, RedCap, OnCore, Velos eResearch, Advarra eReg
• Working with multiple clinical research sites simultaneously
  
  

Nationally Accredited Certification In

• Clinical Research
  
  

Commitment to Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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