Oncology Clinical Research Associate (CRA Manager)
Join a leading edge, award winning, strong growth, industry leader, global organization with immediate Oncology Research & Clinical needs! We are a dynamic , Fortune 500 organization that is recruiting for an Oncology Clinical Research Associate (Senior Site Manager)!! This position is located in the Baltimore, MD area.
We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. What matters most to us is helping people live full and healthy lives .
We develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. You will have an impact to our success !
This position will be responsible for :
- Site recruitment, patient recruitment and retention planning, site initiation, monitoring and close-out .
- You will ensure compliance with all Global Clinical Operations (GCO) Standard Operating Procedures (SOPs), policies and regulatory requirements from start-up through data-base lock.
- You will partner with the Clinical Trial Assistant (CTA)/Investigator Document Assistants (IDA), Local Trial Manager (LTM) and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols .
- You will serve as primary point of contact and liaison between investigational site staff and GCO study team once site is initiated.
- You will lead the Site/Investigator selection process by providing recommendations from local area.
- Execute activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/Work Instructions (WIs)/Instructions for Use (IFUs) and policies.
- Plan, conduct and document site staff training and monitor site performance.
- Work with LTM to ensure Corrective Action/Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits.
- Mentor new hires with supervision and serve as Lead Site Manager (SM)/SM EDC Specialist for a specific trial as needed .
- A minimum of an Associate’s degree or completion of a Nursing Program (RN ) is required. A Bachelor’s degree in a Health or Science discipline is a plus.
- A minimum of 3 years of clinical monitoring experience is required.
- Clinical research monitoring experience in Oncology is required .
- Experience with Phase II and Phase III Clinical Trials required.
- Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Experienceworking with computer software applications is required.
- Willingness to travel approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
We are a " Blue-Chip" leading edge, award winning organization that is making a difference in the cancer fight! Our position has a very competitive $115-135k base salary, plus bonus, plus strong benefit & retirement programs. We have multiple positions open and our interview process will move quickly!