Senior Clinical Research Associate - Oncology - East Coast
What you will be doing:- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
- Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations.
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- Provides regular site status information to team members, trial management, and updates trial management tools.
- Completes monitoring activity documents as required by sponsor's SOPs.
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
- Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed.
- Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
- Verifies serious adverse event (SAE) reporting according to trial specifications and ICH GCP guidelines.
- Communicates with investigative sites.
- Updates applicable tracking systems
- Ensures all required training is completed and documented.
- Functions with little oversight (Sr level)
- May serve as a subject matter expert for clinical operations on monitoring related activities (Sr level)
- May be assigned to complex studies and/or sites.
- Provides leadership skills to assigned projects within the clinical operations department.
What you need to have: - Highly responsive and proactive, team player
- An undergraduate degree or its equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required.
- 2-5 years clinical monitoring experience required (CRA 2 for sponsor)
- 5+ years clinical monitoring experience required (Sr CRA for sponsor)
- Knowledge of ICH and local regulatory authority regulations regarding drug
- Read, write and speak fluent English.
- Oncology monitoring II/III experience required
- Serves as observation and performance visit leader.
- Experience doing feasibility/site selection/site start up required.
- Budget negotiations experience preferred.
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
- May be assigned clinical tasks where advanced negotiating skills are required.
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
