Clinical Research Associate II

Required Qualifications (as evidenced by an attached resume):
Bachelor’s degree (foreign equivalent or higher). Three (3) or more years of full-time related human clinical research experience working with study participants in person. Experience with data analysis, data collection and electronic database entry.

Preferred Qualifications:
Certifications for clinical research (i.e Certified Human Research Biomedical Course, research HIPPA training, GCP certification). Experience in Microsoft Office. Experience with hospital electronic medical record review (i.e Cerner Powerchart). Experience working with an IRB (Investigational Review Board) for research protocol submissions, amendments and reviews. Experience with professional communication and correspondence with sponsors and IRB in obtaining approvals and maintenance of clinical trial materials and documents. Experience with research informed consent process for subject enrollment into trials in-person. Experience speaking with patients in acute (i.e ED or ICU settings) and non-acute settings (i.e outpatient office), explaining procedures involved with the clinical trials, reviewing the consent form and obtaining signatures. Experience writing clinical notes in hospital EMR. Experience with accountability of trial materials and data. Experience with organizing and coordinating subject visits and communication with clinical teams and physicians regarding these visits. Experience with coordinating various research trials and ensuring compliance with federal guidelines.

Brief Description of Duties:
Be responsible for management of clinical trials conducted at Stony Brook University, Neurosurgical Department. Will conduct screening and recruitment of patients; obtain study informed consent, data collection, and quality assurance. Will assist with study-related administrative tasks, such as preparing IRB submissions, interim progress reports, updating study databases and study-related correspondence. Will work closely with the sponsors and site physicians for study management. Demonstrates basic computer proficiency. Meets clinical competency requirements. Develops and maintains open dialogue with patient and key personnel to communicate schedule and protocol changes to assure compliance with research project. 

Duties:

• Recruit, screen, consent and assist with schedule of research patients for Neurosurgery clinical research trials; collect and submit clinical trial patient data, coordinate patient appointments.

• Maintain collected data in an electronic database.

• Maintain study protocol documents and IRB compliance.

• Perform various administrative duties; maintenance of clinical research study supplies and drug/device accountability.

• Educate families as well as clinical staff on the research protocol and investigative study drugs/devices.

• Coordinate patient appointments and assessments as per study protocols.

• Demonstrate proficiency with hospital EMR, basic computer skills.

• Coordinate various research trials and ensure compliance with federal guidelines.

• Interact and correspond with various internal and external constituents including sponsors, cooperative groups, Institutional Review Board and regulatory agencies.

• May assist the principal investigator with grant submissions and renewals.

• Attend conferences and research meetings.

• Assure timely communication of regulatory documents to the IRB. Reports Serious Adverse Events as they occur and assist with the completion of FDA and Sponsor forms in accordance with GCP timelines. Oversees research equipment and study supplies.

• Maintain knowledge and assure adherence to the Code of Federal regulations related to clinical research. 

• Maintain current certification in Human Subjects Research as required

• Facilitate the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication

• Partner with departmental IT resources in the development of databases; data coding manuals and data entry guidelines.

• Ensure that adverse events and protocol deviations are submitted to the IRB.