Senior Clinical Research Associate – Early-Stage Development

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Responsible for ensuring performance and compliance for designated protocols and sites within a country.

• Guarantee that study execution adheres to ICH/GCP, national regulations, company policies, quality standards, and adverse event reporting obligations.

• Serve as the main point of contact and site manager during all stages of clinical research studies.

• Enhance and grow the clinical research territory by identifying and developing new sites.

• Engage in internal meetings and workstreams as a subject matter expert in monitoring processes.

• Build strong relationships with sites and ensure continuity throughout all phases of trials.

• Conduct clinical study site management and monitoring in accordance with relevant standards, laws, regulations, protocols, and monitoring plans.

• Coordinate tasks with sponsor roles to achieve Site Ready status.

• Take part in site selection and validation processes.

• Execute both remote and on-site monitoring and oversight activities.

• Conduct validation, initiation, monitoring, and close-out visits.

• Document accurate visit reports and non-visit contact summaries.

• Gather, review, and oversee regulatory documentation for study initiation, maintenance, and closure.

• Communicate with investigators and site personnel regarding protocol execution, recruitment, retention, deviations, documentation, audits/inspections, and site performance.

• Identify, evaluate, resolve, and escalate issues related to site performance, quality, and compliance.

• Collaborate with internal operations, finance, regulatory affairs, pharmacovigilance, legal, regional, and headquarters teams, as well as vendors, IRB/IECs, and regulatory bodies.

• Manage information and documentation within CTMS, eTMF, and other systems.

• Act as a process subject matter expert, sharing best practices, recommending enhancements, and providing training.

• Support or lead audit and inspection activities.

• Identify prospective new sites and assist in developing their clinical research capabilities.

• Mentor and support junior CRAs and conduct co-monitoring visits.

• Carry out quality control visits when assigned and adequately trained.

⛳️ Requirements

• ESD experience is essential.

• An Associate’s degree, certificate, or equivalent in a scientific or healthcare field plus at least 7 years of relevant healthcare experience, including at least 4 years of direct site management (monitoring) experience in bio/pharma/CRO; OR a bachelor’s degree or higher with a minimum of 4 years of direct site management experience in bio/pharma/CRO.

• Willingness to travel domestically and internationally approximately 65%-75% of the working time; expected travel of about 2-3 days per week.

• A valid driver’s license is required.

• Proficient in local languages and English, both verbal and written.

• Strong understanding of clinical research, clinical trial phases, current GCP/ICH, and national clinical research laws and guidelines.

• Knowledge of global and regional clinical research guidelines and the ability to operate within them.

• Proven ability to mentor and lead others.

• Working knowledge of Good Documentation Practices.

• Demonstrated site management skills, including independent oversight of site performance and patient recruitment.

• Proven monitoring skills with the ability to exercise independent professional judgment.

• Proficient in IT, including MS Office and clinical IT applications on computers, tablets, and mobile devices.

• Capable of understanding and analyzing data/metrics and responding appropriately in a virtual environment.

• Experience in conducting motivational site visits to enhance site enrollment.

• Ability to manage complex issues and work in a solution-focused manner.

• Proficient in root cause analysis and implementing preventative/corrective actions.

• Competent in mentoring junior CRAs and conducting co-monitoring visits.

• Strong time management, organizational, interpersonal, conflict management, and problem-solving abilities.

• Ability to work independently across multiple protocols, sites, and therapy areas.

• Capacity to prioritize and manage multiple tasks in a dynamic environment.

• Effective in a matrix multicultural environment while maintaining culturally sensitive working relationships.

• Customer-focused with a high-quality and compliance-oriented mindset.

• A valid driving license is necessary.

• Visa sponsorship is not available.

🏝️ Benefits

• Eligibility for annual bonuses.

• Long-term incentive eligibility, if applicable.

• Medical, dental, and vision healthcare benefits for employees and their families.

• Additional insurance benefits for employees and their families.

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

• Paid holidays.

• Vacation days.

• Compassionate leave days.

• Sick leave days.

• Remote work options available.

• No relocation necessary.