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 workloadVisa sponsorship: NoneMust be able to start in 1-2 weeks

Location:

Must be located in Texas at the time of applicationTravel 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. Heres 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 - ACRP2. Clinical Research Coordinator (CRC) CertificationOffered 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 Policies3. Good Clinical Practice (GCP) CertificationOffered 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 Practice4.

Human Subjects Protection TrainingOffered 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 Research5. Basic Life Support (BLS) CertificationOffered by: American Heart Association (AHA) or

Red CrossRequirements:

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 TrainingEach certification strengthens a CRCs knowledge base and credibility, and many employers favor candidates with one or more of these credentials. recblid 6d3nq6oje3itik08j2i2hxwsajm9to Not Specified