Apply on Employer Site

Hawthorne Health, Inc. · 3 days ago

Dermatology Provider - Clinical Trials - Principal Investigator/Sub Investigator Preferred

Lindenwold, NJ

Contract

Hybrid

Senior Level

Hawthorne Health is a leading community site network and home research visit solution provider, with over 2,000 healthcare professionals across the U.S. They are seeking an MD, NP, or PA-C with Dermatology expertise to support Clinical Trials as a Therapeutic Area Subject Matter Expert. The role involves conducting assessments, managing clinical trials, and ensuring compliance with study protocols and regulatory requirements.

Clinical TrialsHealth CareInformation Technology

Responsibilities

Conduct standardized disease activity and damage assessments using validated instruments, including: SLICC/ACR Damage Index, BILAG (British Isles Lupus Assessment Group Index), SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index), CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index), Physician Global Assessment of Disease Activity (PGA), and Joint count assessment

Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable

Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements

Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff

Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight

Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment

Review and interpret laboratory results, ECGs, and other diagnostic tests

Make critical medical decisions regarding participant care, adverse events, and protocol deviations

Ensure accurate, complete, and timely collection and documentation of all study data

Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities

Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team

Participate in site initiation visits, monitoring visits, audits, and inspections

Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas

Qualification

Dermatology expertiseClinical Trials experienceExperience treating LupusPI/Sub-I experienceGCP knowledgeCTMS/EDCCommunication skillsDetail-orientedOrganizational skillsTime managementCollaboration skills