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Clinical Research Associate 3

The Fountain Group LLC

Durham, NC

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JOB DETAILS
SALARY
$50–$62 Per Hour
SKILLS
Academic Research, Biology, Budgeting, Clinical Monitoring, Clinical Research, Clinical Trial Management, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Management, Data Quality, Documentation, FDA Requirements, GCP (Good Clinical Practices), ICH Regulations, Informed Consent, Investigational New Drug (IND), Metrics, Nursing, Oncology, Performance Analysis, Pharmacovigilance, Pharmacy, Problem Solving Skills, Quality Monitoring, RMON, Regulations, Safety Compliance, Site Evaluation, Standard Operating Procedures (SOP), Startup, Time Management, Trend Analysis
LOCATION
Durham, NC
POSTED
6 days ago
The Fountain Group is currently seeking a Clinical Research Associate III for a prominent client of ours. Details for the position are as follows:
  • Pay: $50-62/hr.
  • 12-month assignment with possibility for extension or conversion based on performance and budget.
Responsibilities:
  • Serve as the sponsor-side point of contact for assigned sites, providing direct oversight of site performance, protocol execution, and overall study conduct throughout the trial lifecycle.
  • Conduct on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, initiation, routine monitoring, and closeout visits, in alignment with the monitoring plan, sponsor SOPs, ICH/GCP, and applicable regulations.
  • Provide sponsor oversight of critical study processes, including informed consent, eligibility confirmation, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data quality.
  • Evaluate site performance, operational readiness, and quality trends using monitoring observations, study metrics, and site interactions to identify actual or emerging risks.
  • Escalate significant site issues, quality concerns, and compliance risks in a timely manner, and partner with the Clinical Trial Manager and broader study team on mitigation strategies and follow-up actions.
  • Collaborate closely with CRO monitors, vendors, data management, medical monitoring, pharmacovigilance, clinical scientists, and study management to ensure alignment on site status, issues, and study priorities.
  • Provide sponsor-level oversight of CRO-delivered monitoring activities, as applicable, including review of monitoring quality, timeliness of follow-up, issue escalation, and adequacy of site action plans.
  • Review source-oriented and site-level information to confirm that subject safety, protocol compliance, and key study endpoints are being managed appropriately, with particular attention to the complexity of early-phase oncology trials.
  • Support study start-up and maintenance activities by contributing to site feasibility, site activation readiness, training, enrollment oversight, and ongoing site engagement.
  • Track and follow critical site issues, protocol deviations, data queries, action items, and inspection readiness activities to resolution, ensuring appropriate documentation and communication across stakeholders.
Qualifications:
  • Bachelor’s degree in life sciences, nursing, pharmacy, or a related scientific field preferred.
  • Minimum of 5 years of clinical monitoring experience, with strong oncology monitoring experience required.
  • Direct Phase 1 oncology monitoring experience is required, including experience with dose-escalation studies, complex eligibility and safety assessments, and early-phase operational challenges.
  • Prior experience in a sponsor-side or sponsor-dedicated CRA role is preferred; candidates should demonstrate the ability to operate with a sponsor mindset and exercise sound judgment beyond routine monitoring activities.
  • Experience monitoring NCI-sponsored studies, cooperative group studies, or academic oncology research networks is preferred.
  • Strong working knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight expectations, including the ability to recognize and escalate risks related to subject safety, data integrity, and protocol compliance.
  • Experience working with CRO partners and cross-functional study teams, with the ability to communicate clearly, influence effectively, and drive issue resolution across multiple stakeholders.
If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
 
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About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/

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