Clinical Research Assistant

Title: Clinical Research AssistantFLSA Status: Non-ExemptShift: 8-5 with flexibility to meet the needs of the business.Reports to: Director of Clinical ResearchDepartment: ResearchEmployment Status: Full-Time Supervisory Responsibilities: NoneLocation: WilmingtonDate Created/Last Evaluated: 06/03/2024Knowledge, Skills and AbilitiesSupervisory Responsibilities: NoneEssential Functions (%)

• Administrative role in a clinical trial site setting*** Summary: To serve as a clinical research assistant during the conduct of clinical research at the investigative site. Provides administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the Principal Investigator and governed by Good Clinical Practice and International Council for Harmonization and assisting with ongoing study activity. Qualification Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Minimum Qualifications
• Clear criminal history
• Demonstrated human relations and effective communications skills are required
• Understand the ethics of confidentiality and the ability to maintain confidentiality of sensitive information
• Ability to communicate well with physicians, staff, and patients
• Employees shall exhibit tact and diplomacy at all times
• Maintain a positive and professional attitude in all aspects of work from patient care to interaction with co-workers and physicians
• Demonstrated computer skills including working knowledge of Microsoft Office Applications and applicable EMR/Practice Management systems
• Valid drivers’ license and reliable transportation to allow individuals to provide support to offsite locations as necessary
• Enjoys a fast paced, challenging, changing environment; possesses the energy and commitment to help the organization move forward
• This employee must demonstrate the ability to perform the essential functions of the job outlined in the position description.
• Maintains confidentiality of patients and their medical information
• Detailed oriented and excellent records maintenance skills.
• Ability to communicate effectively both orally and written
• Proactive individual with the ability to be a self-starter with strong independent decision-making skills and attention to detail
• Ability to foster a cooperative work environment. Possess willingness to accept orders and to perform repetitive tasks.
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to make evaluative judgments.
• Skill in the use of personal computers and related software applications to include Microsoft Office
• Ability to function well while involved in multiple task assignments. Ability to concentrate on details and deal with constant interruption. Skill in organizing resources and establishing priorities.
• Attends and completes in-service training as required and provides appropriate documentation to supervisor and Human Resources
• Knowledge of HIPPA and other compliance requirements
• Willingness to obtain research specific training as needed
• Must be able to meet deadlines for multiple concurrent projects
• Ability to understand and follow study specific protocol and direction
  
  

Note: The statements below are intended to describe the general nature and level of work to be performed by employees within this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Maintains mandatory training requirements according to guidelines/conditions set by, for example, the International Air Transport Association (IATA), Good Clinical Practice (GCP), etc.

• Completes Clinical Trials Management System and electronic/paper case report forms in an accurate and timely manner
• Obtains and prepares regulatory documents throughout the duration of a study as directed including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms. Documents and forms are compiled and submitted in a timely manner, as requested to the CRO or study sponsor
• Maintains constant communication with Institutional Review Boards, study sponsors, dialysis facility and field staff as necessary to ensure timely study start-up or the effective and efficient progression of the study
• Assist with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of the study as directed
• Interfaces with patients for the purpose of promoting participation in research studies
• Assists with scheduling of potential research patients
• Assists with the screening of patients for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol under the direction of the Principal Investigator
• Assists with and documents the obtaining of informed consent
• Assists with the timely and accurate data entry of study specific data into case report forms. Timely and accurately addresses and resolves study sponsor questions, concerns, queries in accordance with timelines established by the study sponsor
• Processes and ships study specific lab specimens as directed by the Principal Investigator
• Performs study specific procedures at protocol directed intervals under the supervision of the Principal Investigator as instructed
• Provides general support for research projects as directed by the Principal Investigator, Direct Supervisor, or site colleagues
• Obtains and updates licensure and regulatory documents for specific studies, study site, as necessary
• Assists with study close-out activities as directed by Principal Investigator or Direct Supervisor
• Restocks and cleans exam rooms maintaining a clean and orderly work are
• Keep supervisor informed of high-risk situations
• Provides at minimum a four (4) week notice in the event of terminating employment willingly
• Other duties as assigned
  
  

Physical Demands

• Hearing, visual acuity, depth perception, balancing, handling, and talking.
• Reaching, grabbing, holding – fine motor skills
• Extended periods in a stationary or standing position
• Repetitive motion such as entering data into computer-based programs
• Lift or move up to 25 pounds. Employee is expected to use appropriate ergonomics and tolls such as hand carts for heavier loads
  
  

Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work Schedule is Monday- Friday, 8 am to 5 pm with a one-hour lunch. Modifications may be made to this schedule with approval from Director of Clinical Research Site Operations
• Work is normally performed in a typical interior/office work environment. The noise level is usually moderate.
• Interaction may include but not limited to patients, field staff, physicians, study sponsor representatives
• While performing the duties of this job, the employee is regularly required to stand and talk or hear.
• The employee is occasionally required to sit and stoop, kneel or crouch and requires full range of body motion, manual and dexterity and eye-hand coordination
• The employee must frequently lift and/or move up to 30 pounds. The employee is expected to use the appropriate tools provided such as hand carts to carry heavier loads.
• The employee may be required to assist in patient transfer and should use appropriate techniques and equipment to safely transfer patients.
• Keying of data requires repetitive motion
• This position requires eyesight (corrected or uncorrected) that allows the employee to accurately read job related materials, accurately read and record patient related information, and any other functions that require the employee to accurately see data
• Moderate risk of exposure to blood borne pathogens and OPIM
• Must be willing to travel to research dialysis facilities and other office locations of the organization
• Ensure patient safety through all processes and procedures
• Must be able to work overtime hours as needed to accomplish the mission of the organization
  
  

Benefits: 401(k) includes Safe Harbor and Profit Sharing / Choice of Medical Insurance Plans / Dental / Paid Disability and Life Insurance / Optional Life, Accident and Critical Insurance / Generous Paid-Time-Off

Eastern Nephrology is the region’s largest, private medical practice specializing in diseases and disorders of the kidney. Our continued growth is a direct result of providing excellent service and care to our patients. ENA is always seeking talented and compassionate clinical and administrative people to join our practice family.

Eastern Nephrology is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited by local, state or federal laws. We are an E-Verify Employer. Pre-employment background checks are required for all employment positions. If you are a qualified individual with a disability and are unable or limited in your ability to use or access the online application system process due to your disability, please contact the Human Resources Department at 252-864-2049 to request assistance. The company provides reasonable accommodations to qualified individuals with a disability to enable them to effectively participate in the application process, as required by law.

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