Clinical Research Coordinator

Background Information

We are looking for a clinical research coordinator, with research experience. We are looking for a full-time worker, 5 days/week 8:00 am-4:30pm (flexible) with paid holidays and time-off and flexibility. Life/Work balance is an important aspect of our company and we strive to maintain a high degree of flexibility for personal time.

We offer a unique environment for all where you will have the opportunity to work with pharmaceuticals on the development of new drugs. As a study coordinator, you'll be responsible for executing the study protocol, collecting study data, and reporting data to the study sponsor. Patient care is about 20-30% of the daily work, with desk and lab work taking up the remainder of the day. We have a friendly and relaxed work environment that makes it enjoyable to be at work.

Job Requirements

The candidate should have experience and CRC skills such as starting taking vital signs, performing basic assessments, starting IVs, etc. Must have excellent interpersonal, written, and verbal communication skills. The candidate must be well organized, honest, and hard-working, and have strong ethics as it relates to human subject clinical trials. Ability to work with a variety of people from various backgrounds, including physicians, study monitors, participants.

Typical Responsibilities

• Read and review study protocol, including the study indications, methodology, proceedings, timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Coordinates with the Principal Investigator (PI) and study management team to help ensure that clinical research and related activities are performed in accordance with company standard operating procedures and federal regulations.
• Prepare documents necessary to conduct study research.

• Collects documents needed to initiate the study and submit to the sponsor.

• Works with the management team to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.

• Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Capture and record data regarding patients, screenings, and visit data as required by the protocol or company policy with a high degree of accuracy.
• Coordinates participants tests and procedures, ensure phone calls, emails, and text messages are sent prior to visits (these can be automated).
• Collects data Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Completes study documentation and maintains study files in accordance with sponsor requirements
• Maintains effective and ongoing communication with sponsor, research participants, and PI during the course of the study.
• Works with the PI to manage the day to day activities of the study including problem-solving, communication and protocol management
• Process labs and package for shipment to the central laboratory.
• May be required to travel to various local sites where we operate. Typically, schedules will be for the entire day at a site.

Job Type: Full-time

Benefits:

• Paid time off

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday
• Night shift
• Weekends as needed

Education:

• High school or equivalent (Preferred)

Experience:

• Clinical Trials: 1 year (Required)
• Clinical Research: 1 year (Required)

Language:

• Bilingual English - Spanish (Preferred)