Description
Senior Clinical Research Associate
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute’s Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
Benefits:
- Student Loan Repayment
- Tuition Reimbursement/Assistance Programs
- Paid Personal Leave
- 401k (100% annual match – 3%-9% of pay based on years of service)
- Medical, Dental, and Vision Insurance
- Identity Theft Protection discounts
- Auto, Home, and Life Insurance options
- Adoption Assistance
- Employee Stock Purchase Program (ESPP)
**This is a Work-From-Home position and you can be located anywhere in the United States to be eligible for this role.
Summary of Position:
The Senior Clinical Research Associate (Sr. CRA) will be a key member of the team and will utilize their knowledge as a resource to help other CRAs develop their skills. The Sr. CRA will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with Sarah Cannon or sponsor standard operating procedures (SOPs), monitoring plan (MP), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), regional specific regulatory requirements, ensuring study completion on time and within budget. They may be called upon to interact independently with sponsors involved in their projects, and to assist in some relevant departmental tasks and initiatives. This position will focus on the onsite monitoring of Early Phase Oncology trials (Phase I-III).
Duties and Responsibilities:
- You will perform Pre-Study Visits (PSVs), Site Initiation Visit (SIVs), Routine Monitoring Visits (RMVs) and Close Out Visits (COVs), in accordance with ICH/GCP, study-specific requirements, monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards.
- You will attend, participate and present at Investigator Meetings.
- You will document routine Monitoring Visit Reports (MVRs) and follow-up letters as per required timelines in the MP ensuring clear and concise documentation of clinical study progress (i.e. patient recruitment, CRF data entered/monitored, outstanding queries, and risks with data integrity, patient recruitment, data backlog, and/or adherence to study procedures according to the protocol)
- You will Review Case Report Forms (CRFs) and source documents to conduct source data verification (SDV) according to the MP, protocol, ICH/GCP and region specific regulations.
- You will ensure inspection readiness by collecting and reviewing documents in the investigator site file (ISF) and submitting them to the Trial Master File (TMF).
- You will conduct investigational product accountability to ensure accuracy, proper storage, dispensation and reconciliation.
- You will update Clinical Trial Management System (CTMS) as required by CTMS user manual and project specific requirements.
- You will ensure site Institutional Review Board (IRB) approval is current and all IRB documentation is complete and accurate.
- You will proactively anticipate/identify issues and errors that put the project at risk, using experience to know what to look for.
- You will ensure the investigator(s), clinical site team, and facility remain acceptable according to the protocol, ICH/GCP and region specific regulations through the life of the clinical trial.
- You will be required to travel 60%-80% for this role, including overnight stays, and may involve travel to meetings or attendance at conferences. In addition, weekend and evening travel may be required depending upon the workload and nature of current programs.
For this position, you must have:
- Bachelor’s College Degree (4 year program)
- At least 3 years of CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites with experience in Phases l ΓÇô lll.
- Have performed all visit types (PSV,SIV, RMV, and COV).
- Demonstrated leadership skills.
- Demonstrated successful high performance in CRA II competencies for candidates with less than 3 years of experience.
- Ability to travel 60%-80%.
It is preferred that you have:
- Bachelor’s College Degree (4 year program)
- At least 5 years of CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites with direct oncology monitoring experience in Phase l ΓÇô lll in solid and liquid tumor types
- Have performed all visit types (PSV, SIV, RMV, and COV)
- Previous experience in a Sr. CRA role.
- Lead CRA experience.
Do you find this opportunity compelling? If so, we encourage you to apply. We promptly review all applications. If you are highly qualified, you will hear from one of our recruiters. We are actively interviewing so apply today.
We are an equal opportunity employer and value diversity at our company. We do not discrimination the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.