Clinical research coordinator

Job: Fulltime or pat time, in person only Remote option: None Monday to Thursday 730am to 430 pm Friday 9-1 or off depending on workload Visa sponsorship: None Must be able to start in 1-2 weeks Location: Must be located in Texas at the time of application Travel reimbursement: None Experience; Must have clinical research experience and understanding of below expectations and certifications must be up to date at the time of application Commitment: Minimum 2 years commitment required A Clinical Research Coordinator (CRC) plays a key role in managing clinical trials and studies, working under the supervision of a principal investigator (PI) and within a clinical research team. Their responsibilities include coordinating and overseeing clinical trial operations to ensure they comply with regulatory standards, protocol requirements, and ethical guidelines. Here’s an overview of key tasks a CRC typically handles: Key Responsibilities: Participant Recruitment and Screening: Identifying and recruiting eligible participants, obtaining informed consent, and screening participants according to the study protocol. Data Collection and Management: Collecting accurate data during study visits, managing patient files, and ensuring data integrity. Regulatory Compliance: Ensuring that all aspects of the study comply with regulations from institutional review boards (IRBs), the FDA, and other regulatory bodies. Study Coordination: Scheduling and organizing study visits, tracking patient progress, and ensuring that study procedures are followed. Documentation and Reporting: Completing case report forms (CRFs), maintaining proper documentation, and preparing reports for regulatory authorities and the sponsor. Budget and Resource Management: Assisting in budget preparation, tracking expenses, and managing study-related resources. Essential Skills: Attention to Detail: Vital for ensuring accuracy in data collection and regulatory compliance. Communication: Strong interpersonal skills for interacting with participants, researchers, and regulatory authorities. Organizational Skills: Ability to manage schedules, documentation, and data efficiently. Knowledge of Clinical Research Regulations: Familiarity with Good Clinical Practice (GCP), FDA, and HIPAA requirements. Educational Background: Typically, CRCs have a background in life sciences, nursing, or a related field, often with certifications like Certified Clinical Research Coordinator (CCRC) or Clinical Research Professional (CRP). While not always mandatory, certain certifications significantly enhance a Clinical Research Coordinator's (CRC) qualifications and are often required or preferred by employers. Here are some key certifications for CRCs: 1. Certified Clinical Research Coordinator (CCRC) Offered by: Association of Clinical Research Professionals (ACRP) Requirements: A minimum of 3,000 hours of professional experience performing tasks related to clinical research coordination, along with completion of an eligibility review and passing a certification exam. Focus: This certification covers study management, ethics, safety, data handling, and GCP compliance. CCRC Certification - ACRP 2. Clinical Research Coordinator (CRC) Certification Offered by: Society of Clinical Research Associates (SOCRA) Requirements: Candidates must have at least two years of experience in clinical research and meet other educational or professional requirements. Focus: Emphasizes the knowledge and skills needed for conducting clinical trials, including study management, regulatory practices, and patient care in clinical trials. Certification Program Policies 3. Good Clinical Practice (GCP) Certification Offered by: Various organizations, including the National Institute on Drug Abuse (NIDA) and The Collaborative Institutional Training Initiative (CITI) Requirements: Completing a GCP course to understand and comply with the principles of Good Clinical Practice, a key aspect of clinical research. Focus: Teaches international ethical and scientific quality standards for designing, conducting, and reporting trials. Good Clinical Practice 4. Human Subjects Protection Training Offered by: CITI Program, NIH, and other research institutions Requirements: Online training that covers ethical principles and regulatory requirements for protecting participants in clinical trials. Focus: Provides CRCs with an understanding of ethical considerations and informed consent processes for human subjects. Courses in Clinical Research 5. Basic Life Support (BLS) Certification Offered by: American Heart Association (AHA) or Red Cross Requirements: A course and exam, generally requiring renewal every two years. Focus: Teaches basic emergency care skills, which can be helpful in clinical settings. 6. HIPAA Certification (Health Insurance Portability and Accountability Act) Offered by: Multiple online training providers Requirements: Completion of an online training on HIPAA regulations. Focus: Helps CRCs understand and comply with privacy regulations for handling patient data. HHSC HIPAA Privacy Training Each certification strengthens a CRC’s knowledge base and credibility, and many employers favor candidates with one or more of these credentials. #J-18808-Ljbffr