Central Clinical Research Coordinator II
United States · À temps plein
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- Expérience
- 2–3 ans
- Salaire
- 75 000 à 90 000 USD par an
- Ouvertures
- 1
- Publié
- il y a 2 heures
- Mode de travail
- Au bureau
- Éducation
- Licence
- CV
- Candidature requise
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Description de l'emploi
About Adams Clinical
Adams Clinical is a prominent network of clinical trial sites dedicated to speeding up the development of transformative medicines. Their mission is to achieve exceptional standards of data quality, participant safety, and diverse enrollment to propel healthcare forward. Their vision is to become the benchmark for clinical trial excellence. The organization values scientific rigor, operational excellence, commitment to sponsors and participants, and authentic collaboration, fostering a culture where impactful work drives meaningful change.
At Adams Clinical, employees experience a culture filled with respect, openness, and ongoing improvement, along with opportunities for professional growth and working in a team focused on innovation and integrity to positively impact lives.
Role Overview
The Central Clinical Research Coordinator II plays a pivotal role as the operational lead across the entire multi-site research network specialized in late-phase industry-sponsored trials focusing on psychiatric and neurological conditions. They are responsible for ensuring operational excellence from study initiation through close-out by collaborating with site teams, central departments including Enrollment, Quality, Regulatory, and sponsors to guarantee consistent execution, enrollment success, data integrity, and protocol compliance.
Key Responsibilities
- Own full accountability for study success network-wide by monitoring enrollment metrics, data quality, protocol adherence, and milestones from activation through close-out.
- Continuously assess study status at assigned sites by analyzing enrollment, screening data, visit compliance, deviations, query responses, data quality, and operational KPIs, proactively addressing potential risks to outcomes.
- Support the database lock process by ensuring all data queries and sponsor requests are completed timely for successful closure readiness.
- Serve as a clinical operations consultant by conducting periodic site visits to evaluate readiness for new studies, expansions, sponsor audits, and operational improvements.
- Collaborate closely with Site Managers and teams to devise and implement action plans tackling operational risks, enrollment challenges, sponsor escalations, and corrective measures.
- Oversee adherence to procedures, study protocols, Good Clinical Practice (GCP), and sponsor requirements at the site level.
- Conduct operational readiness evaluations, reviewing staffing, training, workflow, facilities, equipment, and regulatory compliance.
- Lead new site launches and integration of acquired sites by ensuring systems, standard operating procedures, staffing, and reporting frameworks are effectively established.
- Identify and drive standardization of Site Operations workflows to reduce variability, enhance consistency, and minimize operational risks.
- Bridge Clinical Operations and Quality teams to support audit preparation, inspection readiness, and implementation of corrective/preventative actions.
- Manage network-wide projects by tracking metrics, timelines, dependencies, and standardizing reporting and documentation.
- Coordinate rollouts of protocol amendments, study updates, and operational changes across all sites, sharing best practices to encourage standardization and ongoing enhancement.
- Lead or assist in cross-functional initiatives like process improvement, technology deployments, workflow optimization, sponsor-driven projects, and organizational scaling.
- Provide operational expertise for business development, including site readiness assessments, enrollment forecasting, and sponsor engagement support to ensure their satisfaction.
- Build and maintain effective sponsor relationships by delivering proactive updates, resolving execution challenges, and facilitating successful study completion.
Qualifications
- Previous experience as a Clinical Research Coordinator (CRC) is mandatory.
- A bachelor's degree is required.
- 2 to 3 years of experience in clinical research, project management, or clinical operations, preferably in site management, CRO, or sponsor settings.
- Comprehensive knowledge of clinical trial operations encompassing study execution, site workflows, participant coordination, regulatory compliance, GCP standards, and use of Electronic Data Capture (EDC) systems.
- Experience managing relationships with sponsors effectively.
- Capability to translate corrective strategies into operational actions and lead their execution with urgency and consistency across the network.
- Exceptional organizational and analytical skills to handle multiple priorities across complex multi-study, multi-site portfolios in a dynamic environment.
- Excellent communication skills skilled at issue escalation, analysis of operational data, and proposing effective solutions.
- Familiarity with reporting tools, dashboards, and operational monitoring systems is preferred.
- Experience in neurology or psychiatry therapeutic areas is advantageous.
- Willingness to travel as needed for site visits or conferences to support operational readiness and initiatives.
- Experience reviewing Clinical Trial Agreements is a plus but not mandatory.
Compensation and Benefits
The salary range offered for this position is from $75,000 to $90,000 per year.
- 401(k) matching program.
- Comprehensive medical, dental, and vision insurance coverage.
- Employee assistance programs.
- Flexible spending accounts and health savings accounts.
- Life insurance benefits.
- Paid time off and parental leave.
- Support for professional development initiatives.
Equal Opportunity and Employment Verification
Adams Clinical is dedicated to being an equal opportunity and affirmative action employer. Hiring and employment decisions are made solely based on qualifications relevant to the position, without discrimination based on legally protected characteristics including age, gender identity, race, ethnicity, religion, disability, or military status.
Employment is contingent on providing valid documentation as proof of identity and work authorization within the required timeframe. The company also participates in E-Verify to confirm employment eligibility.