Clinical Research Associate Jobs

Description:

POSITION DESCRIPTION

Position Title: Clinical Research Associate

Reports To: Vice President, Clinical Affairs

Department: Clinical Affairs

FLSA Status: Exempt

Scope of Role: Individual Contributor

Version Date: 2022.02.15

Job Code: ClinResAssoc

Job Grade: TBD

PURPOSE OF POSITION

The Clinical Research Associates (CRA) will participate in the planning, development, and execution of clinical studies to evaluate the safety, effectiveness, and performance of the Quantra system. He/she will support study activities to ensure compliance with the protocol and regulatory requirements and within the projected timelines.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

• Lead the development of case report forms and serve as sponsor contact for company providing electronic data capture system.
• Support and maintain documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.
• Ensure quality by maintaining compliance with the protocol. Review adverse events and device complaints, reviewing audit reports, and implementing corrective actions (when needed)
• Develop site and study documentation including protocol training materials, work instructions, reports, consent documents and monitoring plans.
• Support investigational device administration including all documentation for forecasting, shipping, receiving, disposition, and returned goods.
• Train and support site staff and project staff on all aspects of the clinical monitoring and study protocol (investigators, coordinators).
• Coordinate clinical study activities including site screening, initiation, and monitoring visits.

Requirements:

KEY COMPETENCIES

• Good prioritization and organizational skills
• Good understanding of biostatistics and study design
• Ability to be point of contact for investigators and site staff on a clinical study
• High attention to detail and accuracy
• Ability to independently oversee study activities with little supervision
• Excellent problem-solving skills
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Ability to identify customer requirements and manage expectations for clinical studies
• Working knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.
• Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Understands databases, data analysis, and data presentation
• Proficient computer skills including WORD, EXCEL and database querying and reporting skills
• General clinical data monitoring skills: paper and EMR
• Demonstrated skills in organizational and project administration skills, tracking study activities for timeliness and completeness
• Working auditing and self-auditing skills

EDUCATION & EXPERIENCE REQUIREMENTS

• 2 + years clinical site monitoring experience
• BS degree in life science, nursing or equivalent
• Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support

PHYSICAL AND COGNITIVE DEMANDS

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential functions of the job. Reasonable accommodations may be made to

enable individuals with disabilities to perform the essential functions.

• This position may include Domestic US and International travel as needed, up to 40%.
• This position is primarily based out of the company Headquarters in Durham, NC.

While performing the duties of this job, the employee is regularly required to:

• Listen and communicate using both verbal and written feedback. Must be able to exchange accurate information in these situations.
• Maintain a high level of consistent cognitive function.
• Lift up 50lbs at times.
• Be fully vaccinated against Covid-19 or meet the requirements for a medical or religious exemption
• Stoop, kneel or crouch when maneuvering the office environment.
• Perform consistent keyboarding/computer use in a typical office environment for extended periods of time, up to 8 hours per day
• Frequently move about the office.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions and perform any other duties, as assigned by their manager