Research Associate II

Job Profile Summary 

​This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. A senior level role that requires advanced knowledge of job area typically obtained through advanced education and work experience. Typically responsible for: managing projects / processes, working independently with limited supervision, coaching and reviewing the work of lower level professionals, resolving difficult and sometimes complex problems. 

Job Overview 

This position is responsible for the development, implementation, management, and administration of clinical trial protocols. Interfaces with federal and corporate sponsors, inpatient and outpatient facilities, departments, and personnel to ensure collaborative environment and high-quality outcome. Coordinates and delivers patient care. Supervises and trains support personnel. 

Job Description 

Minimum Qualifications: 

1. Bachelor’s degree in clinical area. 

2. Appropriate licenses, certifications, and/or registrations related to clinical training. 

Preferred Qualifications: 

1. Experience with clinical trials. 

2. Experience in inpatient and outpatient healthcare delivery. 

Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned. 

1. Reviews proposed protocols with the Principal Investigators to assess the feasibility of undertaking the project.  

2. Assists in preparation of initiating documentation, budget preparation, and resource and personnel allocation, and consent form creation. 

3. Works as a liaison with IRB to facilitate approval of projects and ongoing documentation and reporting. 

4. Liaisons with sponsor agency and monitoring personnel.  

5. Corresponds with all industry-sponsors concerning screening information for each clinical trial and other non-patient sponsor requests. 

6. Interacts with PI and collaborating physicians, inpatient and outpatient facilities, and personnel to comply with study protocols and requirements. 

7. Performs all study start-up responsibilities for all cancer clinical trials (including obtaining approval from the Investigational Pharmacy, Grants and Contracts Office, etc.). 

8. Coordinates and manages patient recruitment, monitoring and documentation of care and progress. 

9. Provides direct patient care including interviewing to obtain relevant historical, medical personal and physical data for patient data collection forms. 

10. Collects specimens and prepares, handles, stores, and mails as necessary for various protocols. 

11. Records test results accurately and timely, inpatient hospital records, case report forms, and MD's own record (clinic charts). 

12. Provides patient information, instruction in written and verbal form in patient diary, keeping medication usage and protocol compliance. 

13. Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working groups' achievement of goals, and to help foster a positive work environment. 

14. Responsible for coordination of all Pre-Site Initiation Visits, Site Initiation Visits, Monitoring Visits, Closure Visits for all active clinical trials. 

Physical Requirements:  

1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.  

2. Frequently required to speak, hear, communicate, and exchange information.  

3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters, numbers and symbols.  

4. Requires manual dexterity using fine hand manipulation to operate computer keyboard. 

Skills & Abilities: 

1. High degree of organizational talents, data collection, and analysis skills. 

2. Requires meticulous attention to detail. 

3. Excellent computer skills including word processing. 

4. Ability to prioritize quickly and appropriately. 

5. Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators and sponsors. 

6. Care in organization and systematic record-keeping.