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Clinical Research Specialist
2 months ago
The Clinical Research Provider (CRP) collaborates with the CND team to facilitate various scientific investigations for the organization. This includes (a) conducting IRB-approved clinical trials, (b) engaging in IRB-approved exploratory research programs involving human participants, and (c) implementing quality enhancement initiatives with healthy individuals. The CRP is instrumental in the evaluation, treatment, and assessment of human subjects involved in these sanctioned research domains, which encompasses the collection of punch skin biopsies in accordance with the company's validated diagnostic testing protocols. The CRP leverages extensive clinical expertise and refined research methodologies while interacting with patient-subjects and healthy participants, consistently upholding high standards of professionalism as a licensed healthcare provider.
Key Responsibilities:
- Engages in various aspects of research programs, studies, and initiatives, including subject recruitment, eligibility assessment, and enrollment of individual participants, clinical evaluations, management of symptoms resulting from adverse events, and basic treatment as outlined in approved protocols.
- Assumes a primary role in obtaining small skin biopsy samples from patient-subjects following established protocols, conducted at authorized clinical facilities.
- Interprets approved research protocols and the Investigator Brochure.
- Documents necessary data on subjects as specified by research protocols using electronic data capture (eDC) and other data collection methods.
- Ensures quality and participant safety through ethical practices.
- Adheres to all medical responsibilities as per protocol, including CND's standard operating procedures (SOPs), OSHA regulations, Good Clinical Practice (GCP), and local laws.
- Escalates potential study risks to the Clinical Program Manager (CPM).
- Performs additional duties as assigned.
Qualifications:
- At least 5 years of clinical research experience as an Investigator or Sub-Investigator within a healthcare system, life sciences organization, or Contract Research Organization (CRO).
- Preferred therapeutic experience in neurology, particularly in movement disorders.
- Eligible to provide patient care and perform procedures in the United States.
- Experience in Phase I, II, or III clinical trials for drug development or large-scale validation studies is required.
- Significant experience and proficiency in conducting skin biopsy procedures.
- Familiarity with NIH and other government-sponsored protocols is advantageous.
- Strong communication skills with patients.
- CITI GCP certification or willingness to obtain within the first month of employment.
Education and Licensure:
- Current unrestricted license to practice as a Nurse Practitioner (NP), Physician Assistant (PA), Medical Doctor (MD), or Doctor of Osteopathy (DO) in Arizona.
- Bachelor's degree in a relevant field.
