Senior Clinical Research Associate – Early Stage Development

This is a fully remote position, open to applicants in Florida, +1 more state.

📋 Description

• This position is responsible for overseeing performance and compliance for designated protocols and sites within a specified country.

• Under the guidance of the CRA-Manager or CRD, the individual ensures that study conduct adheres to ICH/GCP standards, local regulations, company policies, quality benchmarks, and internal and external adverse event reporting requirements.

• Serves as the primary contact and site manager throughout all stages of a clinical research study, taking full responsibility for assigned sites.

• Proactively develops and enhances the territory for clinical research by identifying and cultivating new sites.

• Engages in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.

• Cultivates robust relationships with sites and ensures the continuity of these relationships throughout all trial phases.

• Executes clinical study site management and monitoring activities in accordance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and related documents.

• Attains a comprehensive understanding of the study protocol and associated procedures.

• Coordinates and manages various tasks in collaboration with other sponsor roles to ensure Site Readiness.

• Contributes to site selection and validation activities.

• Conducts both remote and on-site monitoring and oversight activities utilizing various tools to guarantee:

• The data generated at the site is complete, accurate, and unbiased, and that the rights, safety, and well-being of subjects are safeguarded.

• Performs site visits, including but not limited to validation, initiation, monitoring, and close-out visits, documenting clear, comprehensive, and accurate reports in a timely manner.

• Gathers, reviews, and monitors the necessary regulatory documentation for study initiation, maintenance, and closure.

• Communicates with Investigators and site personnel regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

• Identifies, evaluates, and resolves site performance, quality, or compliance issues and escalates as necessary, collaborating with the CRA-Manager, CRM, TA Head, and CRD as appropriate.

• Collaborates internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, as well as externally with vendors, IRB/IECs, and Regulatory Authorities in support of assigned sites.

• Manages and maintains information and documentation in CTMS, eTMF, and other relevant systems in accordance with timelines.

• Contributes significantly to CRA team knowledge by serving as a Subject Matter Expert (SME), sharing best practices, suggesting improvements, and providing training as needed.

• Supports and/or leads audit and inspection activities as required. In alignment with the strategy defined by the CRD and CRA-Manager, aids in identifying new potential sites and collaborates closely with them to enhance clinical research capabilities.

• Mentors and supports junior CRAs on process and study requirements, and performs co-monitoring visits when suitable.

⛳️ Requirements

• Experience in early-stage development is essential.

• An Associate’s degree, certificate, or equivalent in a scientific or healthcare field, along with a minimum of 7 years of relevant experience in healthcare, including at least 4 years of direct site management (monitoring) experience in bio/pharma/CRO. Early Stage Development experience is required.

• Alternatively, a Bachelor’s degree (or higher) with at least 4 years of direct site management (monitoring) experience in a bio/pharma/CRO. Early Stage Development experience is required.

• Proficient in local languages and English (both verbal and written) with exceptional communication skills, including the capability to comprehend and present technical information effectively.

• Strong understanding and working knowledge of clinical research, the phases of clinical trials, and current GCP/ICH & country clinical research laws and guidelines.

• Thorough understanding of Global, Country/Regional Clinical Research Guidelines and the ability to operate within them.

• Proven ability to mentor and lead effectively.

• Practical knowledge of Good Documentation Practices.

• Demonstrated skills in Site Management, including independent management of site performance and patient recruitment.

• Display a high level of monitoring skill with independent professional judgment.

• Proficient in IT skills (including MS Office and various clinical IT applications on computers, tablets, and mobile devices) and the ability to adapt to new IT applications across multiple devices.

• Ability to comprehend and analyze data/metrics and respond appropriately, even in a virtual environment.

• Experience in conducting motivational visits to enhance site enrollment.

• Capable of managing complex issues and working in a solution-oriented manner.

• Engages in root cause analysis and implements preventative and corrective actions.

• Capable of mentoring junior CRAs on process and study requirements and performing co-monitoring visits where applicable.

🏝️ Benefits

• Medical, dental, and vision healthcare, along with other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick days.