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@ Pharmaron
  • Post Date : Oct 22, 2024
  • Apply Before : Nov 22, 2024
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Job Detail

  • Offered Salary 0
  • Commitment Full Time
  • Compensation Paid
  • Required education level Bachelor’s degree

Job Description

We are seeking a dedicated and experienced Principal Investigator (PI) to join our Phase I Clinical Research Unit. The ideal candidate will possess an MD degree and have at least 5 years of clinical experience. While clinical research experience is not required, a strong commitment to patient care, ethical standards, and the ability to lead and collaborate within a multidisciplinary team is essential.

The Principal Investigator will be responsible for a variety of specialized clinical research activities, ensuring that established protocols are implemented, maintaining protocol integrity, monitoring participants’ status and safety, and playing a significant role in the education of clinical staff and clinical trial participants.

 

Key Responsibilities:

Clinical Oversight:

  • Lead and oversee clinical trials in Phase I, ensuring adherence to all regulatory and ethical guidelines.
  • Provide medical expertise and oversight for study participants, ensuring their safety and well-being throughout the trial.
  • Conduct physical examinations and review medical histories of study participants.

Protocol Development and Implementation:

  • Collaborate with cross-functional teams to develop study protocols, including the selection of appropriate endpoints and safety assessments.
  • Ensure proper implementation of study protocols and make necessary adjustments to protocols as required.

Data Analysis and Interpretation:

  • Review and interpret clinical data to ensure accuracy and completeness.
  • Collaborate with biostatisticians and other team members to analyze study results and prepare clinical study reports.

Regulatory Compliance:

  • Ensure all clinical trials are conducted in compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements.
  • Prepare and submit required documentation to regulatory authorities.

 

  1. Patient Interaction and Communication:
  • Communicate effectively with study participants, explaining the trial process, potential risks, and benefits.
  • Obtain informed consent from participants and address any concerns they may have.

Team Leadership and Collaboration:

  • Lead a multidisciplinary team of clinical research professionals, including nurses, coordinators, and data managers.
  • Foster a collaborative and productive working environment, providing guidance and mentorship to team members.
  • Oversee all staff involved in obtaining informed consent from potential participants.
  • Be available to provide medical advice and support in case of emergency or unanticipated serious incident.

Study Monitoring and Reporting:

  • Attend dosing of studies and review adverse events to determine the relationship of the event to the investigational drug.
  • Review and complete case report forms.
  • Ensure subject safety throughout participation.
  • Provide consultation to scientific staff and study sponsors in the design, implementation, conduct, and reporting of research studies.
  • Support activities related to clinical studies, including meeting with study sponsors, and providing input to scientific staff on study design.
  • Identify and develop additional capabilities that may lead to additional business opportunities.
  • Develop good medical practices for all clinical staff to ensure Pharmaron CPC continues to provide the highest level of participant care and safety.
  • Assure compliance with external regulatory agency standards.

Clinical Research Activities:

  • Work closely with the Medical Director to develop and implement policies and procedures that ensure high-quality service.
  • Provide oversight to all staff involved in study execution as signatory on FDA Form 1572.
  • Function as the Principal Investigator or Sub-Investigator for Clinical Research Studies, ensuring all protocol guidelines are met.
  • Provide medical safety review of clinical research protocols as requested by sponsors.
  • Maintain external relationships with physicians, hospitals, and community health centers to assist with study needs and participant recruitment.
  • Evaluate clinical laboratory and study examinations.
  • Monitor and document all participants’ adverse events, medical conditions, and responses to study medications and treatments.
  • Attend industry events to ensure optimum exposure of Pharmaron CPC.

Qualifications:

  • MD degree from an accredited medical school.
  • Minimum of 5 years of clinical experience in a healthcare setting.
  • Demonstrate proficiency in performing essential functions, such as data collection, data entry, and data retrieval within Pharmaron CPC’s electronic data collection system, ClinSpark, in accordance with role responsibilities and study specific protocols.
  • Attend required company-wide or departmental trainings to ensure knowledge of processes and the ability to perform essential tasks are current and aligned with standard requirements and protocols.
  • Strong understanding of medical ethics and patient care.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team-oriented environment.
  • High level of attention to detail and strong organizational skills.
  • Commitment to continuous learning and professional development.
  • Current and valid state medical licensure.
  • Current CPR Certification is required.
  • ACLS Certification is required.
  • Knowledge of state and federal laws and FDA regulations governing healthcare, clinical research, and pharmaceutical drug development.
  • Demonstration of interpersonal, oral, and written skills for communication with research subjects and healthcare professionals.
  • Good Clinical Practice (GCP) knowledge.
  • Competency in medicine, biology, administration, and management.
  • Critical thinking, active listening, judgment, and decision-making skills.

Preferred Qualifications:

  • Previous experience in clinical research, though not required, is a plus.
  • Familiarity with regulatory requirements and GCP guidelines.
  • Strong analytical and problem-solving skills.
  • Board certified / eligible by a specialty board approved by the American Board of Medical Specialties.
  • Specialty in Internal Medicine, Emergency Medicine, or Family Medicine.
  • Maintains current DEA license.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to work on cutting-edge clinical trials and contribute to the development of new therapies.
  • Supportive and collaborative work environment.
  • Professional development and career advancement opportunities.
  • Generous benefits program including health, dental, vision, dependent care, and health flexible spending account, vacation, holiday and sick pay, short and long-term disability, life insurance, and 401(k).

Work Schedule:

  • Full-time
  • Monday to Friday, weekends as needed

Primary Care Specialties:

  • Internal Medicine
  • Primary Care

License/Certification:

  • BC/BE (Preferred)
  • Medical License in [State] (Preferred)
  • Current CPR Certification (Required)
  • ACLS Certification (Required)

 

Availability:

  • The PI or their designee will be available 24/7 when there are participants enrolled in a study for which the PI has signed an FDA Form 1572

 

Supervisory/ Mentoring Responsibilities:

  • Provide oversight to all staff involved in study execution.
  • Provide direction to Clinical Staff, Clinical Research Coordinators, Clinical Laboratory Staff, Pharmacy Staff, Business Development, and Data Management.

 

Work Environment:

  • The worker is not substantially exposed to adverse environmental conditions; works in a temperature-controlled environment.

 

Physical Demands:

  1. Physical Activity:
  • Reaching, standing, walking, pushing, pulling, lifting, fingering, grasping, talking, hearing, and repetitive motion.
  1. Physical Requirements:
  • Medium work, exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
  1. Visual Acuity:
  • The worker is required to have close visual acuity for activities such as preparing and analyzing data, transcribing, viewing a computer terminal, extensive reading, visual inspection, using measurement devices, and assembly or fabrication of parts at distances close to the eyes.

 

Position Type and Expected Hours of Work:

  • Full-Time – 40+ hours per week

 

Travel:

  • None
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