Oncology Clinical Site Monitor II

Advocate Health and Hospitals Corporation•Charlotte, NC

11d•Remote

About The Position

This position is fully remote with the possibility of infrequent travel. The ideal applicant would have a bachelor’s degree with clinical research experience, including oncology experience and/or experience monitoring clinical research studies and/or conducting audits of studies. In addition to experience at a contract research organization (for example - PPD, ICON, Parexel, IQVIA Clinical Research Experience) or pharmaceutical company (Merck, Bristol-Myers Squibb, Astra Zeneca, Novartis, Johnson and Johnson), working at a site level as a research data manager, clinical research coordinator, clinical research assistant, research project manager have more transferrable experience than solely work in research labs.

Requirements

Excellent written and verbal skills as well as excellent organizational and interpersonal skills.
Be familiar with current Good Clinical practices and the Code of Federal Regulations.
A Bachelor's degree in a healthcare or other scientific discipline required.
At least 4 years' experience in clinical research at a pharmaceutical company or a Contract Research Organization (CRO) required with at least 2 years auditing / monitoring experience preferred.
Must be able to be mobile within the entire healthcare system and external locations that participate in LCI clinical trials. Some of these locations maybe out of state.

Nice To Haves

Relevant certification (ACRP, SoCRA, Risk Based Quality Management or equivalent) preferred.
Oncology experience and/or experience monitoring clinical research studies and/or conducting audits of studies.
Experience at a contract research organization (for example - PPD, ICON, Parexel, IQVIA Clinical Research Experience) or pharmaceutical company (Merck, Bristol-Myers Squibb, Astra Zeneca, Novartis, Johnson and Johnson), working at a site level as a research data manager, clinical research coordinator, clinical research assistant, research project manager have more transferrable experience than solely work in research labs.

Responsibilities

Work both independently and as part of a sponsor team commensurate with responsibilities of an Industry/CRO Clinical Trials level II monitor
Handle several priorities within multiple, complex trials
Perform site selection, interim and close-out monitoring visits
Manage studies to ensure adherence to protocol, GCP and regulations, ensuring patient safety, and well-being, as well as verifying accuracy of clinical trial data with minimal oversight from mentors/QA manager
Review study drug storage, stability, inventory, and accountability. Verify destruction of unused product as required
Perform essential Site Regulatory File review and reconciliation.
Communicate findings in a timely manner to all sites per timelines defined in LCI QA SOPs and guidelines.
Set-up meetings, when necessary, to communicate concerns/findings to the site PI/SI
Develop Protocol Specific Monitoring Plans
Independently collaborate with research sites to prepare site for Co-operative Group audits and/or FDA Inspections
Conduct training/presentations to Clinical Trials Site on Quality Assurance and site expectations
Participate in Protocol and eCRF development
Participate in developing and updating LCI QA SOPs, guidelines and processes

Benefits

Comprehensive suite of Total Rewards: benefits and well-being programs
Competitive compensation
Generous retirement offerings
Programs that invest in your career development
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program