Clinical Research Coordinator (Crc)-Ft

Title: Clinical Research Coordinator

Location: San Antonio, TX

ECT

Benefits

· 401(k) matching

· Dental insurance

· Health insurance

· Paid time off (PTO)

· Vision insurance

· Bonus opportunity

Job Description:

The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities:

· Obtains detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.

· Develop draft source documents and review the documents for accuracy and clarity prior to study start up

· Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate

· Reviews with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.

· Manages studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.

· Manages studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.

· Serves as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.

Education and experience:

· High School Diploma or its equivalent; College degree preferred.

· Two+ years of experience, certification as a Clinical Research Coordinator a plus

Skills:

· Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.

· Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.

· Work independently, initiating activity as required and making appropriate decisions within the constraints of study protocols.

• Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Excellent communication skills (interpersonal, written, verbal)
• Basic computer skills to include Word, Excel, as well as proprietary applications unique to the Clinical Research industry (such as Study Manager)

About us:

ERG is a leading U.S. based, privately held, independent Clinical Research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 22 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV Clinical Research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.