Premier Pulmonary Critical Care and Sleep Medicine Clinical research coordinator Denison, TX · Full time

Apply for Clinical research coordinator

Job: Fulltime, 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

Travel reimbursement: None

Experience; Must have clinical research experience and understanding of below expectations and certifications.

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:

1. Participant Recruitment and Screening: Identifying and recruiting eligible participants, obtaining informed consent, and screening participants according to the study protocol.
2. Data Collection and Management: Collecting accurate data during study visits, managing patient files, and ensuring data integrity.
3. Regulatory Compliance: Ensuring that all aspects of the study comply with regulations from institutional review boards (IRBs), the FDA, and other regulatory bodies.
4. Study Coordination: Scheduling and organizing study visits, tracking patient progress, and ensuring that study procedures are followed.
5. Documentation and Reporting: Completing case report forms (CRFs), maintaining proper documentation, and preparing reports for regulatory authorities and the sponsor.
6. 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.