About Company
A pioneering force in medical innovation, Career.zycto champions groundbreaking research that profoundly transforms patient lives. We cultivate an environment where Clinical Research Coordinators flourish, furnishing the essential resources and steadfast support required to excel across diverse and complex studies. Our vibrant, collaborative culture prioritizes scientific precision, unwavering ethical conduct, and the profound, far-reaching impact of impeccably managed clinical trials. Joining our team means becoming an indispensable conduit in bringing novel therapies to fruition, collaborating intimately with passionate professionals dedicated to accelerating scientific discovery and enacting a tangible, positive difference in global health outcomes.
Job Description
Are you a highly organized, detail-oriented clinical research professional seeking the flexibility and autonomy of a remote role? Career.zycto is actively searching for a dedicated and experienced Remote Clinical Research Coordinator to join our dynamic team. In this pivotal position, you will be instrumental in managing the day-to-day operations of assigned clinical trials, ensuring strict adherence to study protocols, regulatory guidelines (ICH-GCP, FDA), and ethical standards. This is an exceptional opportunity to contribute significantly to cutting-edge medical advancements from the comfort of your home office, while collaborating with a passionate team committed to improving patient outcomes worldwide.
As a Remote Clinical Research Coordinator, you will be responsible for coordinating all aspects of clinical research studies, from site initiation and participant recruitment to data management and study close-out. Your expertise will ensure the integrity, quality, and timely completion of clinical trials. This role demands exceptional communication skills, meticulous attention to detail, and the ability to manage multiple priorities effectively in a virtual environment. You will serve as the primary point of contact for investigators, study participants, sponsors, and vendors, facilitating seamless information flow and ensuring all study activities proceed smoothly and compliantly. We value proactive problem-solvers who can navigate the complexities of clinical research with confidence and precision. Join Career.zycto and be a part of accelerating medical breakthroughs.
Key Responsibilities
- Manage and coordinate all assigned clinical trials remotely, from study initiation to close-out, ensuring adherence to study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements (e.g., FDA guidelines).
- Oversee remote participant recruitment, screening, consent processes, and scheduling of virtual or in-person (if applicable for specific study components) study visits, ensuring timely enrollment and retention targets are met.
- Conduct comprehensive source documentation review, accurate data entry into Electronic Data Capture (EDC) systems, and timely resolution of data queries.
- Maintain diligent and accurate study records, including regulatory binders, participant files, and all relevant documentation, ensuring audit-readiness at all times.
- Facilitate remote monitoring visits from sponsors and Contract Research Organizations (CROs), providing necessary documentation and addressing any findings promptly.
- Report all adverse events (AEs) and serious adverse events (SAEs) to the Principal Investigator (PI), sponsor, and Institutional Review Board (IRB) in accordance with protocol and regulatory requirements.
- Collaborate closely with Principal Investigators (PIs), sub-investigators, study team members, and external stakeholders (sponsors, CROs, IRBs) to ensure seamless trial execution.
- Assist with the preparation and submission of IRB applications, amendments, and continuing reviews.
- Provide patient education regarding study procedures, potential risks, and benefits in a clear and compassionate manner.
- Stay current with evolving clinical research regulations, guidelines, and industry best practices to ensure continuous compliance.
Required Skills
- Minimum of 2 years of experience as a Clinical Research Coordinator or similar role.
- In-depth knowledge of ICH-GCP guidelines, FDA regulations, and ethical principles of human research.
- Proficiency in Electronic Data Capture (EDC) systems, Electronic Health Records (EHR), and clinical trial management systems (CTMS).
- Exceptional organizational skills and meticulous attention to detail for accurate data management and record-keeping.
- Strong written and verbal communication skills, capable of effectively interacting with diverse stakeholders remotely.
- Demonstrated ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced, remote environment.
- Proficiency with standard office software (Microsoft Office Suite) and virtual collaboration tools.
- Problem-solving aptitude with a proactive approach to identifying and resolving study-related issues.
Preferred Qualifications
- Bachelor's degree in a health-related science, nursing, or related field.
- Certification as a Clinical Research Coordinator (e.g., CCRC, CCRP) from an accredited organization.
- Experience in specific therapeutic areas such as oncology, cardiology, neurology, or infectious diseases.
- Familiarity with remote monitoring tools and strategies.
- Ability to adapt to new technologies and processes quickly.
Perks & Benefits
- Competitive salary commensurate with experience.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off (PTO) and company holidays.
- 401(k) retirement plan with company match.
- Opportunities for professional development and continuous learning.
- Flexible remote work environment, promoting work-life balance.
- Stipend for home office setup and internet connectivity.
- Collaborative and supportive team culture dedicated to scientific advancement.
- The chance to contribute to impactful, life-changing research.
How to Apply
To apply for this exciting opportunity, please click on the application link below. We look forward to reviewing your qualifications and learning more about your experience in clinical research.
