Clinical Nurse Practitioner (Per Diem) open to non local candidates, will pay travel expenses to site as needed
The Nurse Practitioner (NP) will conduct standardized clinical assessments, focusing on the evaluation of motor and non-motor symptoms of Parkinson's disease, using validated rating scales (e.g., MDS-UPDRS). This role requires strict adherence to trial protocols, Good Clinical Practice (GCP), and successful completion of sponsor-mandated rater training and certification. The selected candidate will work collaboratively with the Principal Investigator to ensure the highest standards of clinical and research quality. This role is anticipated to extend over a three-year period, with variable weekly hours dependent upon patient identification and scheduled screening activities.
The ideal candidate will possess prior clinical research experience and a strong background in neurology and movement disorders, with the ability to perform all study-related ratings onsite in accordance with protocol requirement
Responsibilities:
-Perform clinical assessments of study participants with Parkinson's disease using standardized rating tools (e.g Hoehn and Yahr, MDS-UPDRS, CGI, PGI, Schwab & England ADL, MoCA, EQ-5D-5L, PDQ-39, C-SSRS).
Collaborate with the Principal Investigator and clinical research team to ensure protocol adherence and patient safety.
Participate in and complete all required study and rater training and certification programs provided by the sponsor/CRO
Ensure accurate, consistent and unbiased data collection and documentation in compliance with the study protocol
Report adverse events and other safety data in accordance with protocol and regulatory requirements
Document and report study data in accordance with GCP, sponsor, and site policies.
Maintain compliance with all regulatory, ethical, and institutional standards.
Qualifications:
Expert knowledge of legal and ethical standards for the delivery of medical care.
Expertise regarding applicable compliance requirements including the ability to maintain quality, safety, and/or infection control standards.
Fully GCP trained and able to explain the importance of GCP guidelines to staff.
Ability to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements, and role of the IRB
Strong scientific, analytical, and problem-solving skills.
Collaborative spirit and dedication to team accomplishments, perseverance to overcome short-term challenges and accomplish long-term objectives.
Demonstrated ability to work collaboratively with cross functional departments/groups and different levels of employees to identify quality solutions and effectively achieve business results.
Self-motivated and able to work independently to complete tasks and respond to department requests.
Clear and concise written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively.
Strong organization/prioritization skills for the management of multiple concurrent projects and tasks.
Proactive and timely follow-up skills, including the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
Exceptional ability to develop and maintain strong professional relationships with sponsors, key opinion leaders, and internal stakeholders.
Demonstrated ability to coordinate complex protocols with overlapping timelines.
Proven ability to lead cross-functional teams and manage complex clinical programs.
Knowledge of related accreditation and certification requirements, including ongoing engagement in maintenance of certification for primary board certification.
Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems and eSource.
Education and Experience:
NP degree required from a U.S. accredited Nurse Practitioner Program.
Active Board Certification is required.
Current and Active license to practice in the U.S.
Five (5) or more years of healthcare experience in a U.S. community practice setting, including in neurological disease management or administering clinical scales is highly desirable.
Familiarity with Parkinson's disease and neurodegenerative disorders.
Minimum two (2) years of experience FDA clinical research
Must have experience with movement disorders
Must have experience performing cognitive and behavioral ratings
Must be familiar with performing the following cognitive and behavioral ratings, Hoehn and Yahr, MDS-UPDRS, CGI, PGI, Schwab & England ADL, MoCA, EQ-5D-5L, PDQ-39 and C-SSRS.
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