Job Title: Principal Investigator

Location: Montclair and San Bernardino, CA

Compensation: $126-$150/hr

Shift/Schedule: First shift hours – can have slight flexibility dependent on patient schedule

Type: Contract

Overview:

The Investigator (Principal or Sub) primary duties are to protect human subjects and their rights during the conduct of a clinical trial. In addition, provide oversight of the study team to ensure delegated duties are being performed within protocol, GCP, and federal regulated standards. Ensure integrity and validity of the data obtained during conduct of clinical trials. Promote SOPs, GCPs, ICH guidelines and protocols are consistently being followed on site.

RESPONSIBILITIES:

• Attend Site initiation visits and/or training in-service for all current protocols. Full involvement and oversight in study tasks that are delegated to employees. Oversee and provide guidance to clinical team. Assist in training of all support staff for all clinical trials you oversee.

• Assist in recruitment for clinical trials; refer to other site trials. Set schedule to accommodate patients onsite and/or offsite as necessary. Conduct proper informed consent process according to SOP’s, attain most current ICF version. Evaluate eligibility of patients for inclusion into clinical trials. Collect medical and surgical history, concomitant medication use, and adverse events.

• Document source documents, all inpatient activities, visit progress notes, adverse events, information observed and/or reported along with procedures performed during clinical trial additionally to maintain adequate and accurate records throughout. Review all lab results, fully sign along with providing clinical significance to any out of range, and/or abnormal value.

• Evaluate appropriateness of inclusion into trials; repeat labs if necessary or screen fail patient. and counsel patient to seek appropriate medical care when appropriate. Reinforcement study restrictions, diets, and study guidelines.

• Review, provide insight and sign impending CRFs, electronic CRFs, data clarification forms, and/or data query upon completion. Review contents of source documents, lab and procedures throughout. Assess adverse events and drug reactions, thoroughly record details including relationship to study drug

• Assist in reporting of any serious adverse events to sponsor and IRB. Participate in monthly staff meetings and annual SOP meetings. Read and understand the information in the investigator's brochure, including the potential risks and side effects of the drug.

• Other responsibilities as required by management.

  REQUIREMENTS:

• A qualified person in the relevant field of health care (MD, PhD, PharmD, PA-C, NP) with a minimum of 3 years’ experience in clinical research.

• In depth knowledge of FDA-GCP regulations pertaining to protecting human rights and safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers.

• Have in-depth knowledge of federal regulations regarding responsibilities of a Primary or Sub- Investigator. The Investigator is deemed competent when he/she can thoroughly manage project, read and understand the available information (IB) on the product under investigation, including the potential risks and side effects of the drug and possesses the ability to adhere to the study protocol and investigate the drug under investigation.

• Approximately 20% travel required

• Night/weekend work schedules can occur based on patient availability

• Work is normally performed in a typical interior clinical/office environment. Lifting of 20 pounds and occasionally more than 20 pounds.

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.