Summary:
The Principal Investigator (PI) is ultimately responsible for every aspect of the clinical trial. Even though some responsibilities may be delegated to qualified staff, this does not alleviate the responsibility of the PI (as specified in FDA Form 1572, which is the agreement between the PI and the FDA). This position reports to the Medical Director.
Ark’s Principal Investigators function within the scope of the American Medical Association (AMA), as well as State Laws, and Federal Regulations pertaining to the conduct of clinical trials and Good Clinical Practices. Responsibilities of the PI include, but are not limited to:
DUTIES INCLUDE
CLINICAL:
- Ensuring that clinical trials are conducted according to the signed investigator statement (FDA Form 1572), the investigation plan (the protocol), and applicable regulations
- Thoroughly evaluating and knowing all aspects of study protocols as well as the study drug profile
- Training study team members on study design, objectives, study drug, study indication, and appropriate selection of study participants, assuring adequate safeguards for study participants and strict adherence to the study protocol
- Reviewing potential study participant's medical history and performing physical examinations and/or any other investigator required procedures as specified by the protocol
- Diagnosing and/or excluding medical/psychiatric conditions for purposes of study participation
- Interpreting all medical/diagnostic test results to determine eligibility of potential study participants and accessing consulting physicians if needed for test result interpretation
- Determining appropriate tapering and titration schedules for studies that require such procedures
- Reviewing pertinent medical records requested for study participants
- Reviewing all laboratory reports including screening reports and reports obtained per study protocol and determining the clinical significance of abnormal test results and further appropriate evaluation
- Consulting with potential study participants' personal physicians concerning their participation in clinical trials and clarifying medical issues before potential study participant randomization when appropriate
- Obtaining informed consent from potential study participants and documenting that process according to Ark’s guidelines
- Assessing adverse events and reviewing concomitant medications at each study visit, unscheduled study visits, and as needed at any other point during trial participation
- Determining the clinical significance of adverse events including abnormal lab results and ECGs, and assessing their relationship to study medication
- Making clinical determination of study participant's ability to continue in a trial based upon study participants’ wishes, adverse events, lab tests, ECG results, concomitant medications, and efficacy of study medication
- Consulting with CRO and/or Sponsor contacts concerning study participant safety issues, Inclusion/Exclusion criteria for study participation, serious adverse events, and other participant issues
- Responsible for protecting the rights, safety, and welfare of all subjects under Ark Clinical Research’s care
- Facilitate patient flow and oversee operational execution of trials
ADMINISTRATVIVE:
- Maintaining and updating knowledge of Ark’s Standard Operating Procedures (SOPs) and their proper application
- In conjunction with administration, ensuring continuous investigator coverage when needed as determined by the patient schedule and Site Manager
- Participating in the interview and hiring process for research nurses and sub-investigators when requested
- Attending investigator start-up and site initiation meetings before study enrollment
- Being on-site at each monitor/sponsor visit to meet with monitor and be available for questions, discussions about patients and general study status, including study wide enrollment numbers, recruitment issues, and projected enrollment end dates
- Determining study feasibility for all potential studies with attention to the ability to successfully enroll and conduct the trial – PI is responsible for the success of both the conduct, quality of data, and enrollment of each trial
- Collaborating with the Site Manager in evaluating the clinical/administrative performance of the Research Nurses and Study Coordinators
- Collaborating with medical leadership and CEO in providing performance appraisal for sub-investigators.
- All other duties as assigned.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience:
MD or DO with appropriate certifications and medical license(s). Clinical research experience as a sub-investigator and/or principal investigator. Current American Heart Association Basic Life Support certification required. Current American Heart Association Advanced Cardiac Life Support (“ACLS”) certification recommended. American Heart Association Pediatric Advanced Life Support (PALS) Certification recommended.
Language Ability:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.
Math Ability:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.
Reasoning Ability:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
Computer Skills:
To perform this job successfully, an individual should have knowledge of Microsoft Word and Excel software; Accounting software; Inventory software; Payroll systems; E-mail and internet software and Project Management software.
Certificates and Licenses: See Education and Experience section.
Supervisory Responsibilities:
Directly oversees employees’ study-related performance. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include Close vision. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit.
About Ark Clinical Research:
At ARK Clinical Research, we strive to improve each patient’s quality of life through the development of more effective therapies and devices by conducting high quality clinical trials
Pay: $130.00 - $200.00 per hour
Experience:
- Clinical research: 5 years (Required)
License/Certification:
- MD or DO License (Required)
Ability to Commute:
- Long Beach, CA 90815 (Required)
Work Location: In person
