Clinical Research Associate (Cardiology)

Cardiology Associates of Altoona, L.L.P. is a leading provider of cardiovascular care in the Altoona region, dedicated to improving the lives of patients through advanced medical treatment, research, and innovation. We are expanding our clinical research team to further our mission of advancing cardiovascular care through evidence-based clinical trials. We are seeking a Clinical Research Associate (CRA) with a focus on cardiology to join our dynamic team.

Job Summary:
The Clinical Research Associate (CRA) will be responsible for supporting the coordination and management of clinical trials focused on cardiology. This position involves working closely with cardiologists, clinical staff, and research participants to ensure the successful execution of clinical research projects. The CRA will assist with the regulatory, logistical, and operational aspects of clinical trials to ensure compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines.

Key Responsibilities:

• Study Coordination: Assist in the planning, initiation, and execution of clinical cardiology research studies. Coordinate daily study operations, ensuring adherence to the study protocol, timelines, and regulatory requirements.
• Patient Recruitment and Screening: Work closely with the clinical team to identify, screen, and enroll eligible patients for clinical trials. Ensure informed consent is obtained from all participants in compliance with regulatory and ethical standards.
• Data Collection and Management: Oversee the collection, documentation, and management of clinical trial data, ensuring accuracy, completeness, and integrity of patient records. Maintain up-to-date case report forms (CRFs) and patient files in compliance with GCP.
• Monitoring and Compliance: Ensure compliance with institutional, local, and federal regulations, including IRB approvals and regulatory documentation. Conduct routine site monitoring visits, reviewing study progress, and identifying issues or concerns.
• Collaboration: Act as a liaison between cardiologists, study sponsors, research teams, and other stakeholders. Foster effective communication and collaboration to ensure smooth execution of research projects.
• Adverse Event Reporting: Monitor and report any adverse events or side effects during the course of a study. Ensure proper documentation and follow-up on all reported issues.
• Regulatory Documentation: Assist with the preparation and submission of regulatory documentation, including ethics committee applications, regulatory forms, and progress reports.
• Study Documentation: Maintain accurate and complete documentation for all clinical trial activities, including informed consent forms, regulatory documents, study visits, and any necessary correspondence.
• Quality Assurance: Assist in ensuring that the clinical trials meet the highest standards of quality, from recruitment to data collection to study closure. Participate in audits and inspections as required.

Qualifications:

• Bachelor's degree in a related field (e.g., Life Sciences, Nursing, Health Sciences) is required. A Master's degree or relevant certification in clinical research (e.g., ACRP, SOCRA) is a plus.
• At least 1-2 years of experience as a Clinical Research Associate, preferably in cardiology or a related medical field. Experience in cardiovascular clinical trials is highly desirable.
• Solid understanding of clinical research regulations, Good Clinical Practice (GCP), and FDA/ICH guidelines.
• Strong knowledge of medical terminology, clinical trial protocols, and the healthcare system.
• Experience with clinical trial data management, case report forms (CRF), and patient documentation.
• Ability to effectively manage multiple tasks and prioritize responsibilities in a fast-paced environment.
• Strong organizational and analytical skills, with attention to detail and accuracy in documentation.
• Excellent communication skills, both written and verbal, with the ability to work collaboratively in a multidisciplinary team.
• Ability to maintain confidentiality and ensure ethical conduct in all aspects of clinical research.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and experience with clinical trial management software (CTMS) is preferred.

Preferred Qualifications:

• Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification through a recognized organization (e.g., ACRP, SOCRA).
• Previous experience with cardiology-based clinical trials or experience in cardiovascular medicine.
• Knowledge of electronic data capture (EDC) systems, electronic medical records (EMR), and clinical trial documentation software.

Benefits:

• Competitive salary and comprehensive benefits package, including health insurance, dental, vision, and retirement plans.
• Generous paid time off (PTO) and paid holidays.
• Continuing education support and opportunities for professional development.
• Malpractice insurance coverage.
• Opportunities to work in a collaborative and research-focused environment with experts in the field of cardiology.
• Work-life balance with flexible scheduling options.
• A supportive and innovative workplace culture that encourages growth and career advancement.