Clinical Research Principal Investigator

9 hours ago

San Bernardino, United States American Clinical Research Services Full time

Catalina Research Institute (CRI), an ACRS company is located in Montclair, CA and they focus on Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a Clinical Research Principal Investigator.


Part time role: 10 - 20 hours per week

Full time role: 30 - 40 hours per week


  • The successful candidate must be one of the following and must be licensed in California.
  • MD: Doctor of Medicine
  • The expectation is to work on site in Montclair, CA OR San Bernardino, CA.
  • Ideal candidate is fluent in Spanish and English.
  • Must be qualified in the relevant field of healthcare (MD) with a minimum of 3 years’ experience in clinical research.


The Investigator's 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.


DUTIES AND RESPONSIBILITIES:

  • Attend Site initiation visits and/or training in-service for all current protocols.
  • Maintain current license.
  • Complete required SOP training
  • Full involvement and oversight in study tasks that are delegated to employees.
  • Have in depth knowledge of company SOPs, ICH GCP guidelines and protocols assigned.
  • 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.
  • This may include weekends and holidays.
  • 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.
  • Other responsibilities as required by management.
  • Read and understand the information in the investigator's brochure, including the potential risks and side effects of the drug


EDUCATION/TRAINING

A qualified person in the relevant field of health care (MD) with a minimum of 3 years’ experience in clinical research.


SPECIALIZED TRAINING/CERTIFICATES

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.


COMPETENCY REQUIREMENTS

  • Excellent communication skills
  • Problem Solving skills.
  • Planning /Organizational skills
  • Customer Service skills

TECHNICAL COMPETENCY REQUIREMENTS

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.


PHYSICAL REQUIREMENTS AND OR ENVIRONMENTAL FACTORS

• Mid-level Computer Use

• Night/weekend work schedules

• Work is normally performed in a typical interior clinical/office environment.

• Lifting of 20 pounds and occasionally more than 20 pounds.


About ACRS

American Clinical Research Services (ACRS) Holdings was founded to improve the quality of life for millions of Americans through scientific research. Given the challenges in patient recruiting and the increased complexity around clinical trials, ACRS is focused on the opportunity to achieve efficiencies in a highly fragmented sector.

All employees must be authorized to work in the United States. ACRS provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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