Job Description
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.
Essential Responsibilities And Duties - 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. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills - 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.
Working Conditions - Indoor, Clinic environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Job Tags
Full time,