Job Description
Join Apex Medical Innovations, a leader in pioneering clinical solutions, as our next Senior Medical Research Associate. We are seeking a detail-oriented and innovative professional to drive our clinical trials from inception to publication. If you possess a deep understanding of medical research protocols and a passion for improving patient outcomes, we want to hear from you.
At Apex, we pride ourselves on a culture of excellence and collaboration. As a Senior Medical Research Associate, you will play a pivotal role in shaping the future of healthcare, working alongside world-class scientists and regulatory experts.
Responsibilities
- Design and execute complex clinical trial protocols in alignment with FDA and ICH guidelines.
- Analyze medical data using advanced statistical software (SAS, R, or Python) to ensure accuracy and compliance.
- Oversee the entire study lifecycle, including monitoring site performance and ensuring data integrity.
- Collaborate with cross-functional teams, including biostatisticians, physicians, and regulatory affairs specialists.
- Prepare and submit regulatory submissions, including INDs and clinical study reports.
- Conduct regular audits and quality assurance checks to maintain HIPAA compliance.
- Present findings to internal stakeholders and external conference attendees.
Qualifications
- Master’s degree in Medicine, Biostatistics, Pharmacology, or a related Life Science field (PhD preferred).
- Minimum of 5 years of experience in clinical research, medical writing, or pharmaceutical development.
- Proven proficiency in statistical analysis tools and electronic data capture (EDC) systems.
- Strong understanding of Good Clinical Practice (GCP) and regulatory standards.
- Excellent written and verbal communication skills, with the ability to explain complex medical concepts.
- Ability to travel to clinical sites and attend industry conferences as required.
- Certification as a Clinical Research Coordinator (CRC) or similar is a plus.