Certified Clinical Research Coordinator

Position Title

Clinical Research Coordinator

Salary Range

$26-30/hr

Schedule

Full-time Non-Exempt Status

Hours: Mon-Fri 7:00 am – 4:00 pm

Professional meetings according to scheduled times

Required Qualifications

·     Bachelor’s Degree or commensurate experience in clinical research

·     Bilingual (English, Spanish)

·     ACRP Certification

Required Training

·     Certifications may be completed upon employment

·     CITI GCP – 3-year renewal

·     IATA/Hazardous shipping – 2-year renewal

·     Infection control/ Blood Borne Pathogens – annual renewal

·     CPR/AED 2-year renewal

·     CSSR-S (Columbia Suicide Severity Rating Scale)

Preferred Qualifications 

Graduate Degree

·      Prior experience in a patient care role such as a medical scribe, medical assistant (MA), LVN, or RN.

·      Experience in diabetes and endocrinology or cardiology is a strong plus.

·      Phlebotomy experience (1 years).

Required Skills/Abilities

 Ability to work in a team setting.

·     Ability to learn and become proficient with industry software and computer applications.

·      Skill and proficiency in verbal and written communication, analytical thinking, problem-solving, and multitasking.

·      Ability to work independently in a fast-paced environment with minimal supervision and multiple ongoing priorities.

·      Possess a positive, friendly, and professional demeanor.

·      Proficiency with Microsoft Office.

Reports To

Lead Clinical Research Coordinator

·     Clinical Research Director/CEO

Position Statement

The mission of all staff at Texas Valley Clinical Research (TVCR) is to conduct ethical clinical research that results in medical advances that improve human health while treating participants with dignity and compassion. TVCR exists to produce clear and concise data for our sponsors while helping community members achieve their healthcare goals. Primary Therapeutic Areas of Interest include, but are not limited to, diabetes, obesity, thyroid disorders, liver or kidney impairment, cardiovascular disease, and Alzheimer's Disease. The Clinical Research Coordinator (CRC) is responsible for conducting phases II – V clinical trials under ICH-GCP guidelines and study protocol standards provided by the study sponsor. Attention to detail and excellent oral and written communication skills are essential to success. A successful CRC possesses excellent time management skills and can educate participants about their disease process, medications and treatment, lifestyle, and relevant technology with patience and compassion. Patient care duties include phlebotomy, collection of patient vitals, ECGs, and other technical procedures and skills. Texas Valley Clinical Research's organizational culture is exceptional, characterized by a strong emphasis on teamwork, a love of learning, and a genuine commitment to helping employees reach their professional goals. Supportive, collaborative colleagues will surround you and are always willing to lend a helping hand. The company also values continuous learning and development, providing ample opportunities for training, workshops, and skill-building activities.

Duties/Responsibilities

·      Performs all clinical research duties within regulatory compliance and industry guidelines as described in the Food and Drug Administration (FDA), Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPPA), institutional review boards (IRB), TVCR policies and standard operating procedures (SOP), and sponsor requirements.

·      Understand the importance of maintaining research subject confidentially throughout the duration and upon completion of a trial.

·      Create study-specific source documents based on sponsor-provided study protocol.

·      Perform timely data entry and documentation of completed study-directed assessments.

·      Recruit and schedule new patients contacted through advertisement campaigns or physician referrals for study screening.

·      Conduct and capture documentation of study-directed assessments with study subjects outlined in each study protocol, including but not limited to recording subject history, obtaining and reviewing medical records, collecting vital signs, performing phlebotomy and informed consent, reviewing adverse events, and subject health assessments.

·      Obtain, process, and ship study lab specimens (blood, saliva, urine) for analysis, if needed.

·      Resolve sponsor-initiated data management queries promptly.

·      Assist in preparing source evaluation by sponsor monitors and provide monitor assistance/ feedback.

·      Communicate effectively with study subjects about scheduling, appointment reminders, review of study procedure results, and relaying information from the principal investigator to the subject.

·      Communicate via email or in person with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and study subjects.

·      Perform new duties that arise due to changing clinic needs.

·      Ensure investigational product/study medication is stored and managed correctly.

·      Ensure compliance with sponsor study-specific manuals and guides.

·      Ensure study supplies are on-site when required and manage inventory.

·      Ensure all screening, enrollment, and randomization logs are kept current.

·      Light office cleaning duties.

Work Environment

·    The work environment and physical demands described here are those that an employee must meet to perform the essential functions of this job successfully.

·    Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

·    Work is performed in an office/laboratory and a clinical environment.

·    Exposure to biological fluids and bloodborne pathogens.

·    Personal protective equipment, such as eyewear, garments, and gloves, may be required.

·    Ability to work upright and stationary for 6-10 hours daily.

·    Frequent mobility is required to include occasional squatting, kneeling, or bending.

·    Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time, with or without notice, as the clinic needs to change and grow.