The Clinical Research Site Monitor performs site monitoring duties at clinical study sites. Essential Duties & Responsibilities include the following. Other duties may be assigned. Ensure informed consent procedure is properly followed per IRB/FDA guidelines Prepare any study specific documents (i.e. source documents, chain of custody logs, Case Report Forms, etc.) Ensure study site personnel maintain and update regulatory binder and other study documents throughout the study Ensure study drugs are stored and dispensed appropriately as well as proper documentation is on file Ensure adverse events are properly documented and reported to the IRB and FDA, when appropriate Ensure the code breaking process is properly followed and documented Ensure the study site is following all study required procedures and document/monitor any events of non-compliance or protocol deviations Ensure study site is recrniting from the appropriate population and enrolling at an acceptable rate Ensure accuracy of the data on case report fonns (CRFs) when compared to source documents Ensure completion and legibility of CRFs Ensure the Principal Investigator reviews and signs the CRFs before being brought back to Amphastar Set up and maintain regulatory file folders Research and purchase necessary clinical supplies Assist clinical research associate during pre-study site evaluation meeting, study initiation meeting, monitoring visits and study close-out Prepare submission materials for clinical study report, as needed Prepare for an audit, as needed

Education & Experience:

Bachelor in Science in life sciences or other science related field (i.e. biology, chemistry, microbiology, engineering, etc.); one year or more of related experience and/or training; an equivalent combination of education and experience.

Language Skills:

Ability to read, create and understand clinical study reports; ability to read and understand clinical research protocols/ documents and FDA/local regulations; ability to effectively communicate with clinical research personnel and other essential departments; ability to effectively communicate instructions and study concepts to clinical study sites.

Mathematical Skills:

Ability to calculate figures and amounts. Ability to convert units between SI and empirical system.

Reasoning Ability:

Ability to collect data and establish facts; ability to draw valid conclusions based upon facts.

Additional Requirements:

Computer knowledge including programs (e.g. MS Word, Excel and Outlook), Internet search engines and databases; ability to travel on a regular basis; ability to effectively perform all clinical research analyst duties/requirements. Sunshine Act Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider's name, address, and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address, and the amount of payments made currently will be reported to the government. EEO & Employment Eligibility Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Amphastar also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer. Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Type:

Full-time Pay:

$26.40 - $28.40 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off

Education:

Bachelor's (Preferred)

Work Location:

In person