Principal Investigator Jobs

Possesses extensive experience in clinical research and a passion for advancing medical knowledge

Design and execute clinical research studies in accordance with study protocols, regulatory requirements, and ethical guidelines

Act as key source of knowledge/information on understanding of the medical environment, company's & competitor's product data and unmet medical needs.

Proven experience as a Principal Investigator or substantial involvement in clinical research studies

In-depth knowledge of clinical research regulations, including FDA and ICH guidelines

Strong communication and interpersonal skills to effectively collaborate with colleagues and stakeholders

Strong working knowledge of regulatory requirements and GCP standards.

Adhere to the requirements detailed on the FDA 1572 Statement of Investigator form.

Previous clinical research experience as a Principal Investigator

Assume responsibility as the Principal for the duration of clinical trials.

Possess thorough understanding of the clinical research protocol and patient population for which the trial is designed.

Perform and supervise/review ratings performed by outside physicians, as needed, in accordance with the clinical research protocol.

Substantial experience leading technical teams on advanced R&D programs (e.g., DARPA, AFRL, ONR, ARL research projects)

Experience developing mathematical and physics-based algorithms for constraint-based search and optimization, autonomy and planning, machine learning, networking, or agent-based software design

Knowledge of binary file structures and formats

Knowledge of assembly languages (e.g., x86, ARM)

Knowledge of operating system internals (e.g., scheduling, data structures)

Experience with both offensive and defensive cyber tools

BS with 5+ years' experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field

MS with 3+ years’ experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field

Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.

Experience evaluating, developing, and qualifying manufacturing equipment.

Coauthor sections of regulatory documents relevant to Process Engineering platforms.

PhD in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field

Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required

Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements

Maintain trial documents as specified by guidelines and applicable regulatory requirements

Understanding of regulatory requirements, principles of GCP and biomedical research ethics.

Critical thinking, dynamic problem-solving skills, and attention to detail

Training and certification in Good Clinical Practice (GCP)

Experience and Qualifications for the Principal Investigator Role

Proven experience as a Principal Investigator or Sub-Investigator

You will act as a guardian of participants' health and safety, carefully supervising the study's execution.

Play a key role in maintaining clinical oversight and quality, driving the commercial success of the site.

Engage in thorough review processes, examining enrollment progress, pre-screening, and screening success rates, as well as participant retention.

Participate in strategic initiatives aimed at patient recruitment, and interpret protocols and Investigator Brochures (IB).

Demonstrate the proper education, training, and experience to conduct the clinical investigation

Provide medical management of Adverse Events and emergent events as appropriate

Collaborate with operational and management team to ensure site goals are met

Follow protocol requirements including concomitant medication allowances and review inclusion/exclusion criteria

Complete protocol specific training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols

Attend Investigator Meetings and educational seminars, and travel to Investigators meetings as needed

Job Type: Contract, Part time

Pay: $150 - $200 an hour

•MD or DO, Active License

Proficiency in project management skills

Ability to demonstrate the proper education, training and experience to conduct clinical investigation.

Assists and provides guidance to clinical operations, research staff, and to sponsor client managers as required.

Must be aware of and comply with all applicable regulatory requirements.

Experience as Endocrinologist or GP experience in treatment of Diabetes. Experience with insulin pump therapy.

Strong knowledge of good documentation practices.

Experience with oral solid dosage form manufacturing equipment and processing parameters including scale-up and support for GMP manufacturing.

Experience and understanding of the fundamentals of processes and formulation development for spray dried dispersions.

Managing multi-disciplinary project teams of scientists for technical capability, program progression and career growth.

Leading programs to ensure quality of technical approach, progress reports, and successful client relationships.

Understanding, reviewing, and optimizing workplans to effectively challenge formulation attributes critical to successful formulation strategies.

Utilizing risk assessments to effectively communicate and plan for program considerations associated with formulations and processes.

Strong communication skills and analytical abilities; follows best practices for reproducible research and code version control

Develop/oversee clinico-genomic data analysis plans and manage relationships with clinical assay labs, genomic data vendors and academic research institutes

Experience using public data/annotations such as AACR GENIE, ClinVar, Exome Variant Server, 1000 Genomes, OncoKB, TCGA and COSMIC

Conduct multi-omic data analysis (RNA-seq, DNA-seq, cell-free, single-cell, proteomic, etc.) and integrate with other preclinical, clinical and real-world data sets

Keep well annotated analytical notebooks and code with appropriate version control

Familiarity with industry standards and regulatory guidance for analysis and reporting of clinical biomarker data is desired

Demonstrated advanced level of knowledge in state or federal regulatory FWA requirements or 5+ years of experience

Operational experience with a pharmacy and/or pharmacy benefits manager (PBM)

Demonstrated advanced level of knowledge in health care fraud, waste and abuse (FWA) or 5+ years of experience

Demonstrated advanced level of knowledge analyzing data to identify fraud, waste and abuse trends or 5+ years of experience

Participate in legal proceedings, arbitration, and depositions at the direction of management

Demonstrated intermediate level of knowledge in health care policies, procedures, and documentation standards or 5+ years of experience

Assure that all key research personnel have met training requirements.

Medical Degree and broad-based post-graduate experience

A minimum of 3 or more years of experience in a clinical research position

Broad knowledge of general medicine

Strong analytical and problem-solving skills

Excellent organizational skills, detail oriented, efficient, and able to multi-task and prioritize effectively.