ABOUT WILMINGTON HEALTH

Since 1971, Wilmington Health has been committed to the care and health of our community in Wilmington as well as all of Southeastern North Carolina. Wilmington Health is structured as a multi-specialty medical practice with primary care providers integrated into the system. In this way, Wilmington Health is able to provide a comprehensive and coordinated approach to the care of all our patients. Wilmington Health is committed to using collaborative, evidence-based medicine in providing the highest quality of care to the patients we serve.

Purpose:

Perform a variety of clinical procedures and assist with daily workload planning. Collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs) and Good Clinical Practice (GCP).

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
• Review study protocols, Case Report Forms (CRFs), and other study-specific documents,
• Audit/Monitor electronic data capture systems used to record clinical research data
• Attend all relevant study meetings
• Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research
• Recruit and screen patients for clinical trials and maintain subject screening logs
• Orient research subjects to the study, including the purpose of the study, procedures, and protocols issued
• Design and maintain source documentation based on protocol requirements
• Schedule and execute study visits and perform study procedures
• Collect, record and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness
• Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics
• Monitor subject safety and report adverse reactions to appropriate medical personnel
• Correspond with research subjects and troubleshoot study-related questions or issues;
• Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards
• Assist with study data quality checking and query resolution
• Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring.
• Record, report and interpret study findings appropriately to develop a study-specific database.
• Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
• Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
• Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
• Assist research site with coverage planning related to staffing and scheduling for research projects.

OTHER DUTIES:

• Performs other duties and projects as assigned

Required Skills

QUALIFICATIONS

REQUIRED:

• Bachelor’s degree in a related field • 1-2 years’ clinical experience • 1-2 years’ experience in healthcare or related field • Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies Preferred: • relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training, and experience • Master’s degree in a related field • Knowledge of MS Windows and Office applications such as Access • SQL training • Understanding of medical terminology • Strong organizational skills

ADA PHYSICAL DEMANDS: Rarely (Less than .5 hrs/day) Occasionally (0.6 – 2.5 hrs/day) Frequently (2.6 – 5.5 hrs/day) Continuously (5.6 – 8.0 hrs/day) Physical Demand Required?                              Frequency Standing                               Occasionally Sitting                                  Continuously Walking                                Occasionally Kneeling/Crouching               Rarely Lifting                                  Rarely

Required Experience

QUALIFICATIONS

REQUIRED:

• Bachelor’s degree in a related field • 1-2 years’ clinical experience • 1-2 years’ experience in healthcare or related field • Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies Preferred: • relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training, and experience • Master’s degree in a related field • Knowledge of MS Windows and Office applications such as Access • SQL training • Understanding of medical terminology • Strong organizational skills

ADA PHYSICAL DEMANDS: Rarely (Less than .5 hrs/day) Occasionally (0.6 – 2.5 hrs/day) Frequently (2.6 – 5.5 hrs/day) Continuously (5.6 – 8.0 hrs/day) Physical Demand Required?                              Frequency Standing                               Occasionally Sitting                                  Continuously Walking                                Occasionally Kneeling/Crouching               Rarely Lifting                                  Rarely