Research Assistant - Clinical Trials
Curalta Foot + Ankle, LLC
Westwood, NJ
Posted April 3
Job Description
Curalta Foot + Ankle is the largest and foremost network of podiatrists in the Northeast, focused on delivering high-quality, complete foot and ankle care. Our providers combine decades of experience with a forward-thinking, innovative treatment approach to maximize patient outcomes and experiences across all lower extremity conditions.
The Research Assistant assists with patients involved in Curalta Clinical Trials through evaluating and enrolling patients, including the performance in the medical management of study patients.
Essential Functions, Job Duties & Responsibilities:
- Perform history & physicals (H&P) for study patients as part of the inclusion criteria
- Perform H&P for preoperative medical clearance on study surgical patients
- Review study labs and ECG’s
- Oversee and collaborate with all clinical trial team members as it relates to:
- Regulatory documentation
- Patient advertising, recruitment & scheduling
- Data entry and data quality control
- Consents eligible patients for clinical trials
- Purchasing of supplies and equipment
- General study coordination activities
- Review participant's inclusion and exclusion criteria
- Collect vitals: temp, pulse oximetry, respirations, heart rate, etc.
- Specimen collections and diagnostic assays
- Patient education
- Study treatment administration
- Perform study sub investigator responsibilities in compliance with the approved protocol. The Sub-Investigator may also perform all or some of the functions of the Principal Investigator as delegated by the Principal Investigator. The sub-investigator is under the supervision of the PI and is responsible for performing study-related procedures and/or making important decisions in compliance with the study's ethical conduct.
- Provide ongoing assessment of the study subject/patient to identify Adverse Events and provide medical management of adverse events as appropriate
- Possess a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form.
- Participate from time-to-time in on-call activities as required to ensure adequate medical coverage
- Adheres to protocols and amendments
- Document all findings in subject specific source documents
- Monitors, documents, and reports adverse events according to study criteria and the protocol
- Assists the Director and staff with reports related to the clinical trial as requested
- Delegate study responsibilities as appropriate to trained study staff
- Performs other duties as assigned
Education & Experience:
- Licensed and Certified Physician Assistant (PA-C), or
- Licensed and Board Certified Nurse Practitioner, or
- Licensed MD or DO required
- Licensed DEA and CDS in the State of New Jersey required
- Minimum 2 years research experience required
- Experience with Electronic Health records software (EHR) preferred
Skills and Abilities:
- Excellent verbal and written communication skills
- Solid written and oral communications
- Ability to motivate and lead in a team-based environment
- Proactive and independent with the ability to take initiative
- Resourcefulness, time-management, organization, problem solving and critical thinking skills
- Excellent time management skills with a proven ability to meet deadlines
- Diagnosis and treatment Planning
- Patient Assessment
- Patient Education
- Orders Clinical Tests
- Prescribes medications
- Proficient with Microsoft Office Suite or related software
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer
- Prolonged periods of standing while working with patients
- Must be able to lift to 20 pounds at times