Principal Investigator

CenExel•Marlton, NJ

22d•$260,000 - $350,000•Onsite

About The Position

About Us: Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCPs), and federal/state regulations. Generates independent, high quality, and reproducible results. Collaborate with our study team, as well as various medical, pharmaceutical company and regulatory personnel to ensure the health and welfare of study participants. Responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project. Compensation: $260,000 - 350,000, depending on education, experience and skillset.

Requirements

Must be able to effectively communicate verbally and in writing.
Possess a valid M.D. or D.O. degree.
Board Certified or Eligible.
1-3 years’ experience conducting clinical research trials as either a PI or Sub-investigator, or other relevant experience.
D. or D.O. required.
Active DEA license, or able to obtain one.
Active license to practice medicine in the state of practice, or ability to obtain one.
Medical knowledge and ability to provide clinical information to study teams
Knowledge of medications and general medical conditions
Knowledge and Understanding of GCP/ICH guidelines
Possess a thorough understanding of the requirements of each protocol
Experience in conduct of clinical trials
Demonstrating the proper education, training and experience to conduct the clinical investigation
Knowledge of drug delivery systems and ability to prepare injections, infusions, etc.
Skill in organization and record maintenance
Skill in developing and maintaining effective working relationships with supervisors and co-workers
Ability to complete paperwork with precision and attention to detail
Ability to react calmly and effectively in emergency situations
Ability to interpret, adapt and apply guidelines and procedures
Ability to work independently as well as functioning as part of a team
Ability to communicate clearly, both verbally and in writing.

Responsibilities

Maintain current license to practice medicine.
Maintain current board certification, if applicable
Assume responsibility as the Principal Investigator for the duration of clinical trials
Strong working knowledge of regulatory requirements and GCP standards
Possess thorough understanding of the clinical research protocol and patient population for which the trial is designed
Ensures recruitment goals are reasonable and attainable
Perform any evaluations deemed necessary for the conduct of the trial
Complete training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols
Conduct testing and rating scales per sponsor’s instructions and protocols.
Completion of all documentation, paper and electronic, as required per protocol
Evaluate participants for clinical research trials based on their past medical history in comparison to the protocol specific inclusion and exclusion criteria
Ensure appropriate delegation and training of the clinical research staff
Educate study staff on patient population and mechanism of action of the investigational product
Evaluate subject safety and compliance with the investigational product as specified in the clinical research protocol as well as collaborate with the medical director
Assess participant’s response to investigational therapy and evaluate any adverse events
Adhere to reporting requirements for safety reports, protocol noncompliance and any other protocol required reports
Ensure subject’s informed consent is obtained appropriately throughout the duration of the clinical trial
Adhere to the requirements detailed on the FDA 1572 or Statement of Investigator form
Collaborate with Site Leadership to ensure company goals are met
Provides key budgetary decisions and verifies that appropriate budgets and cost projections are prepared to deliver the proposed project scope
Attend Investigator Meetings and educational seminars.
Assumes other duties and responsibilities as assigned.