Lead Clinical Research Investigator

2 weeks ago

Philadelphia, Pennsylvania, United States Denali Health Full time
Job Overview

Position Title: Clinical Research Lead Investigator
Department: Clinical Research
Employment Type: Flexible

Position Summary:

Denali Health is in search of a skilled and committed Clinical Research Lead Investigator to spearhead and oversee clinical studies within our organization. The Lead Investigator will play a crucial role in maintaining the integrity, safety, and efficacy of clinical trials by managing all facets of study design, implementation, and regulatory compliance. The ideal candidate will possess a robust background in clinical research, a dedication to ethical practices, and a fervor for advancing healthcare.

Core Responsibilities:

Pre-Study Activities:

  • Protocol & Feasibility Assessment:
    • Evaluate the study protocol and internal capabilities to ensure alignment with the proposed study.
    • Provide constructive feedback to sponsors regarding study design and operational considerations.
    • Attend initial meetings with sponsors, site qualification assessments, and site initiation discussions.
  • Regulatory Documentation:
    • Approve necessary Study Start-Up documentation including Investigator's Brochures and financial disclosure forms.
  • Study Initiation & Communication:
    • Engage in study initiation meetings with sponsors to gain a comprehensive understanding of study requirements.
  • Participant Interaction & Screening:
    • Clearly communicate study details to potential participants, addressing inquiries and ensuring informed consent is properly obtained.
    • Assist in screening processes to evaluate participant eligibility.
    • Review screening data and authorize participant enrollment in the study.

During/Post Study Activities:

  • Study Execution & Participant Management:
    • Conduct scheduled and unscheduled physical examinations as per the study protocol or in response to adverse events.
    • Assess and manage adverse events, determining their relationship to the investigational product.
    • Review laboratory results, ECGs, and other study data, taking necessary actions based on findings.
    • Collaborate with sponsors to review ongoing safety data.
  • Safety Reporting & Documentation:
    • Submit reports for Serious Adverse Events (SAEs) and other required documentation in accordance with study protocols.
    • Review and finalize Case Report Forms (CRFs) and Clinical Study Reports.
    • Report all SAEs and Suspected Unexpected Serious Adverse Reactions (SUSARs) to sponsors and regulatory bodies within required timelines.
    • Conduct end-of-study data reviews to assess the need for re-checks.
    • Monitor participant safety through end-of-study physical examinations and follow-ups on ongoing adverse events.
  • Case Report Forms & On-Site Evaluations:
    • Review and sign all Case Report Forms (CRFs) at the conclusion of the study to ensure accuracy.
    • Assist in on-site evaluations of Case Report Forms, providing expert insights and feedback.

Additional Responsibilities:

  • Network Development:
    • Support business development and maintain a network of physician specialists for referrals or study assistance.
  • Sponsor Engagement:
    • Represent Denali Health's capabilities at sponsor meetings and medical conferences.
  • Training & SOP Development:
    • Aid in the development of Standard Operating Procedures (SOPs) and training plans to ensure compliance with clinical safety protocols.
    • Facilitate emergency response training and review clinical safety procedures to ensure site preparedness.

Qualifications:

  • Education:
    • MD or DO degree required; a PhD in a related field may be considered.
    • Board certification in a relevant medical specialty is preferred.
  • Experience:
    • Minimum of 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
    • Proficiency in multiple languages is preferred.
  • Skills & Competencies:
    • Strong leadership and team management abilities.
    • Excellent communication and interpersonal skills.
    • In-depth knowledge of GCP, FDA regulations, and IRB processes.
    • Ability to collaborate effectively with multidisciplinary teams.
    • Detail-oriented with the ability to manage multiple tasks efficiently.

Key Benefits of the Role:

  • Flexible Work Arrangements:
    • Conduct research within your own practice or at our facilities, allowing for flexibility in location.
  • Adaptable Scheduling:
    • Commitment typically requires 5-10 hours per week per study, with many activities manageable in a single day.
  • Competitive Compensation:
    • Receive a competitive salary through a profit-sharing model based on your involvement in clinical research studies.

Why Choose Denali Health?

At Denali Health, we are dedicated to accelerating therapeutic innovations by addressing research bottlenecks and bridging the gap from laboratory to market. We foster an inclusive environment that encourages independence and career development. Join our dynamic organization that values integrity, innovation, and excellence in clinical research.

Denali Health is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

  • Research Investigator Sr.

    7 days ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job Summary:We are seeking a highly motivated and experienced Research Investigator Sr. to join our team at InsideHigherEd. The successful candidate will have a strong background in immunology and direct experience with high-dimensional flow cytometry and high-throughput sequencing techniques.Key Responsibilities:Lead complex research projects, manage...

  • Senior Research Investigator

    7 days ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job SummaryThe Senior Research Investigator will play a key role in leading advanced research projects in the field of neuroscience. The successful candidate will have extensive experience in stem cell biology, molecular biology, and biochemistry, and will be responsible for designing and implementing experiments, generating isogenic hiPSC lines, and...

  • Insurance Fraud Investigator

    7 days ago

    Philadelphia, Pennsylvania, United States Veracity Research Company Full time

    Job Description**Job Summary:**We are seeking a highly skilled and experienced Field Investigator to join our team at Veracity Research Company. As a Field Investigator, you will be responsible for conducting various types of investigations, covert surveillance, and background checks. You will work independently with minimal supervision and be required to...

  • Clinical Research Coordinator

    1 week ago

    Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

    Job SummaryThis position will assist in the management of multiple clinical trials and responsibilities in a specific research area.Key ResponsibilitiesCoordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data.Assist with Institutional Review Board (IRB)...

  • Senior Research Investigator

    7 days ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job SummaryWe are seeking a highly skilled Senior Research Investigator to join our team at InsideHigherEd. The successful candidate will be responsible for overseeing the translation of cell and gene therapies from research to clinical applications.Key ResponsibilitiesDevelop and implement strategic plans for product development and clinical...

  • Oncology Clinical Research Nurse

    2 weeks ago

    Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

    University OverviewThe University of Pennsylvania, a prestigious institution and the largest private employer in Philadelphia, is recognized globally for its excellence in education, research, and innovation. Consistently ranked among the top 10 universities in the U.S. News & World Report, Penn comprises 12 esteemed schools that provide a comprehensive...

  • Clinical Research Specialist I-III

    2 weeks ago

    Philadelphia, Pennsylvania, United States Medix™ Full time

    Clinical Research Coordinator - Medix™Job OverviewThe Clinical Research Coordinator plays a pivotal role in overseeing and facilitating the execution of clinical research protocols. These protocols may be supported by various funding sources, including industry partners, cooperative groups, or grant-funded initiatives. This position is essential in...

  • Lead Clinical Research Systems Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States Temple University Health System, Inc. Full time

    Position Overview - Clinical Research Systems LeadThe Clinical Research Systems Lead is responsible for enhancing the ongoing operational activities of the Clinical Research Management System (CRMS). This role includes supervising System Coordinators in their daily functions, training, and providing guidance to the team. The Lead serves as a key resource for...

  • Clinical Research Coordinator

    7 days ago

    Philadelphia, Pennsylvania, United States InsideHigherEd Full time

    Job Summary:The Clinical Research Coordinator will play a critical role in the organization, coordination, and implementation of research studies at InsideHigherEd. This position will be responsible for participating in the review and preparation of protocols, preparing regulatory documents, and coordinating site visits.Key Responsibilities:Participate in...

  • Oncology Clinical Research Nurse

    1 week ago

    Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

    University OverviewThe University of Pennsylvania, recognized as the largest private employer in Philadelphia, stands as a global leader in education, research, and innovation. This historic Ivy League institution consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. With 12 esteemed schools, Penn offers a wide array...

  • Lead Clinical Research Systems Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Temple University Health System, Inc. Full time

    Position Overview - Clinical Research Systems LeadThe Clinical Research Systems Lead plays a crucial role in enhancing the ongoing operational activities of the Clinical Research Management System (CRMS). This position is responsible for overseeing and guiding the System Coordinators in their daily functions, training, and overall management of the team.The...

  • Oncology Clinical Research Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Actalent Full time

    Job Title: Oncology Clinical Research SpecialistJob OverviewWe are in search of an Oncology Clinical Research Specialist with significant expertise in clinical trials and a robust background as a Registered Nurse. The ideal candidate should possess over 5 years of experience in clinical research, demonstrating a comfort level in engaging with medical...

  • Clinical Research Nurse Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States Actalent Full time

    About the RoleWe are seeking a highly skilled Clinical Research Nurse to join our team at Actalent. As a Clinical Research Nurse, you will play a critical role in coordinating studies and working closely with research investigators to translate discoveries from the bench to the bedside.Key ResponsibilitiesCoordinate clinical research studies, ensuring...

  • Clinical Research Coordinator

    7 days ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at the Trustees of University of Pennsylvania. The successful candidate will be responsible for managing multiple clinical trials, coordinating study activities, and ensuring compliance with regulatory guidelines.Key ResponsibilitiesManage clinical...

  • Clinical Research Coordinator

    7 days ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Job SummaryWe are seeking a highly skilled and experienced Clinical Research Coordinator to join our team at the Trustees of University of Pennsylvania. The successful candidate will be responsible for managing multiple clinical trials and coordinating research activities in a specific area.Key ResponsibilitiesAssist in the management of clinical trials,...

  • Oncology Clinical Research Nurse

    2 weeks ago

    Philadelphia, Pennsylvania, United States Temple Health Full time

    Role OverviewAs an Oncology Clinical Research Nurse, you will play a pivotal role in the coordination and facilitation of clinical research protocols. These protocols may be supported by various entities including NCI, industry partners, cooperative groups, or through grant funding and investigator-initiated studies. Key ResponsibilitiesYour leadership will...

  • Oncology Clinical Research Nurse

    2 weeks ago

    Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

    University OverviewThe University of Pennsylvania, a prominent private employer in Philadelphia, stands as a global leader in education, research, and innovation. This prestigious Ivy League institution consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. With 12 esteemed schools, Penn offers diverse opportunities...

  • Clinical Research Manager in Cardiac Electrophysiology

    1 week ago

    Philadelphia, Pennsylvania, United States Trustees of University of Pennsylvania Full time

    Clinical Research Coordinator in the Cardiac Electrophysiology DivisionThis role entails overseeing various clinical research projects within the Cardiac Electrophysiology Division at the Trustees of University of Pennsylvania. The coordinator will be instrumental in facilitating both industry-sponsored and investigator-led clinical trials, as well as...

  • Genito-Urinary Clinical Research Nurse

    1 week ago

    Philadelphia, Pennsylvania, United States Temple University Hospital Full time

    Genito-Urinary Clinical Research Nurse The role of the Clinical Research Nurse in the Genito-Urinary Unit involves coordinating and facilitating the execution of clinical research protocols that may receive support from various sources including NCI, industry, cooperative groups, or grant-funded and investigator-initiated studies. This position requires...

  • Clinical Research Site Supervisor

    2 weeks ago

    Philadelphia, Pennsylvania, United States Barrington James Full time

    Position Title: Clinical Research Site SupervisorOverview: The Clinical Research Site Supervisor is responsible for ensuring the integrity and quality of clinical trials at designated research locations. This role involves strict adherence to sponsor protocols, regulatory standards, and industry guidelines, with a focus on achieving enrollment targets and...