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Hawthorne Health, Inc. · 21 hours ago

Rheumatologist Consultant - Sub Investigator

Horsham, PA

Full-time

Hybrid

Senior Level

Hawthorne Health is a leading community site network and home research visit solution provider, with a focus on accelerating patient access to clinical trials. The role involves performing comprehensive rheumatologic evaluations, managing patients with autoimmune disorders, and assisting in overseeing clinical trials while ensuring adherence to protocols and patient safety.

Clinical TrialsHealth CareInformation Technology

Responsibilities

Perform comprehensive rheumatologic evaluations and manage patients with autoimmune and inflammatory disorders

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

Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements

Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI

Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings

Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision

Assist the PI in making 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 the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities

Assist with investigational product accountability, storage, and administration according to protocol

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

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

Qualification

Rheumatology expertiseClinical trial managementClinical judgmentCommunication skillsCTMS familiarityEDC systems familiarityEthical conductPatient safetyProblem-solving abilitiesAttention to detailOrganizational skillsTime management