Clinical Research Sub-Investigator

Clinical Research Sub-Investigator Buffalo, NY Job Details Full-time $110,000 - $128,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance Life insurance Qualifications Health screenings Medical documentation Clinical research Research ethical considerations RN License Phone communication EKG Adverse event reporting Customer service Bachelor of Science Patient assessment Writing skills Clinical research experience (1-2 years) Well-being program (employee development activity) Physical examinations Mid-level Diagnostic evaluation Drug therapy monitoring Clinical staff training Clinical research compliance Certified Family Nurse Practitioner Bachelor's degree Staff training Newsletters (communication methods) Patient recruitment Communication skills Health education and counseling FDA regulations

Physician Assistant License Nursing Full Job Description Job Summary:

The Sub-Investigator, under the supervision of the Principal Investigator, is responsible for both clinical and educational aspects of clinical trial studies while focused on interpreting clinical protocols and conducting study visits with subjects.

Duties/Responsibilities:

Clinical Responsibilities Interpret clinical protocols Create telephone screening tools for the call center's use in pre-screening patients Create study summaries, providing a basic overview of the research study as a reference for staff. Advise on Inclusion/Exclusion set up Draft correspondence to subjects and follow up letters to primary care physicians Be familiar with all assigned studies Resource for all staff clinical questions Review marketing materials and give clinical input Conduct study visits with subjects Adhere to good clinical practices and FDA human subject protection guidelines Administer Informed Consent Review and record medical histories Review and record physical assessments Review inclusion/exclusion criteria to determine patient eligibility Review and record medications, indications for use, dates of use Assess patient compliance with study drug and follow-up visits Assess patient's response to therapy Review and sign off lab results and tests in consultation with Principal Investigator if needed Review ECG's and provide a provisional interpretation Assess and document adverse events per company SOPs with final sign off by the Principal Investigators Conduct other visit procedures as assigned by supervisor and delegated by Principal Investigator May share on call phone as needed to support subjects in trials Educational Responsibilities Train applicable staff on informed consent Train recruitment/marketing team on telephone screen tools/protocols Assist in recruitment team training including mock calls Assist staff in understanding clinical requirements of the protocol Attend Investigator's Meetings for new studies, as needed Perform "Free Screen" assessments, provide interpretation and education regarding results. Provide in-services on scientific rationales of studies for clinical staff, as needed. Develop, attain, and provide patient education regarding the clinical trial process as well as diseases and treatments Assist in writing for RCR website and newsletter as needed Assist with workplace wellness initiatives

Required Skills/Abilities:

Excellent verbal and written communication skills. Excellent interpersonal and customer service skills.

Education and Experience:

RN, BS, NP

with NYS certification as Family or Adult NP or PA Two years clinical research experience preferred

Wage/Salary:

$110,000 -128,000/year

Job Type:

Full-time Pay:

$110,000.00 - $128,000.00 per year

Benefits:

401(k) Dental insurance Employee assistance program Health insurance Life insurance Paid time off Vision insurance Application Question(s): Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)? Ability to

Commute:

Buffalo, NY 14217 (Required)

Work Location:

In person