Description

About the Job Position 

Avellino Lab USA (Avellino) is seeking a Clinical Research Associate or Senior Clinical Research Associate (depending on qualification) to manage clinical studies data and documentations at various study sites. The successful candidate will play an important role in ensuring that the clinical research studies run smoothly. Experience with managing clinical trials or clinical research studies in the biotech/biopharma industry is required. This individual will work closely with the rest of our R&D team and with the project management group to manage and track timelines, deliverables and be responsible for the reports of the various ongoing projects and new initiatives.?The position will also be involved in leading project planning sessions, coordinating staff and internal resources, managing project progress, ensuring timelines and meeting deadlines, manage relationships with clients and stakeholders, design contracts, oversee project documents, create project reports, as well as design risk mitigation plan. This position may also provide the opportunity to be hands-on in leading external collaboration projects in clinical test development and preclinical drug development. The successful applicant will bring significant experience managing study sites and assist with site training, study monitoring and compliance documentation including IRB submissions. 

Requirements

Job duties 

• Being very familiar with clinical research protocol, case report form, informed consent, source documentation and patient diary (when applicable), for clinical research studies 
• Ensuring study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner 
• Generating reports for supervisors on patient enrollment and tracking 
• Managing tasks for all clinical research studies at the company – make sure the process is followed, track tasks and timelines, coordinate internally and externally with all teams involved 
• Maintaining accountability of own ongoing professional growth and development 
• Maintaining strict confidentiality of patients and adhering to HIPAA (Health Insurance Portability and Accountability) Guidelines 
• Support the maintenance of a clinical database including ensuring proper data entry and audit 
• Ensure that the clinical study is conducted in compliance with IRB regulations 
• Accumulate appropriate documentation for IRB application and clinical study
• Other duties not specifically listed in this job description, as needed and assigned 

Job Qualifications 

• BSc/MSc in Public health, Clinical Sciences, Data Science, Statistics, Genetics or Biology. A Ph.D. degree in the related fields will be a plus. 
• A minimum of 2 years of clinical research experience is required 
• Previous clinical study project management experience is highly desirable 
• Experience working under regulatory regimes, such as CLIA, CAP or FDA 
• Good clinical practices (GCP) certification and/or Clinical Research Associate certification are highly desirable 
• A solid understanding of the genetic and molecular testing process 
• Excellent verbal and written communication skills
• Must demonstrate good judgment and decision-making capabilities 
• Must be a resourceful and independent thinker 

Additional qualifications

• Consistently demonstrates problem solving and communication skills while interacting with co-workers, hospital employees and customers 
• Works with the Research Center Coordinators at study site to manage the development and tracking of budget, intra-hospital payments, investigator payments and patient payments 
• Assists with coordination of residents, pharmacy students, externs, interns, technician students, and volunteers at study site 
• Works with Research Center staff to provide departmental and intradepartmental staff and patient education for clinical trials 
• Flexibility and self-initiative required to support several external and internal projects in clinical testing, clinical development, and projects involving genomics. 
• Proficient in Microsoft Project applications as well as creating presentations 
• Assist in the implementation, conduct and monitoring of all ongoing studies 

Position Type, Work Environment and Physical Demands 

This is a full-time exempt onsite position. This job operates in a professional office environment. Must be able to climb stairs, be able to lift up to 20 pounds, regularly sit, speak and hear, and perform climbing, standing, stooping, twisting, lifting, and other physical movements to perform job. 

Other Duties 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.