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Medasource · 1 week ago

Senior Field CRA

Phoenix, AZ

Part-time

Hybrid

Senior Level

5+ years exp

Medasource is a company focused on providing clinical research services, and they are seeking a Senior Clinical Research Associate to monitor clinical studies and ensure compliance with regulatory requirements. The role involves coordinating with study teams, reviewing data, training site personnel, and mentoring less experienced team members.

Health CareMedical

Growth Opportunities

Responsibilities

Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits

Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include, but is not limited to:

Reviewing data and source documentation from investigational sites for accuracy and completeness

Ensuring adverse events and protocol deviations are reported in an efficient manner

Ensuring that device complaints and malfunctions are reported according to Policies and Procedures

Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence

Coordinates with study teams, field clinical engineers or designee and specialists to:

Enroll sites into new and ongoing clinical studies

Facilitate enrollment of study subjects via site coordinators

Facilitate resolution of data queries and action items at clinical sites

Promptly reports the findings of monitoring visits according to processes

Collaborates with in-house teams to ensure complete submission of study documents

Participates in conference calls and training sessions

Trains site personnel to ensure compliance with the study protocol and local regulations

Mentors less experienced clinical team members as requested

Demonstrates a high level of written and verbal communication skills with internal and external customers

Qualification

Clinical research experienceClinical monitoring experienceClinical researchCertification (SoCRA/ACRP)Medical devicesAnalytical skillsWritten communication skillsVerbal communication skillsInterpersonal skillsOrganizational skills

Required

A Bachelor's degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field

Superb understanding of all aspects of clinical research

Minimum five years clinical research experience

Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills

Ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees

Basic personal computer skills including a working familiarity with word processing software and relevant clinical applications

The ability to work independently and function within a dynamic, global team environment

The ability to exchange straightforward information, ask questions, and check for understanding

Familiarity with cardiac, vascular, and/or neuromodulation technologies

Preferred

Strong preference for prior clinical monitoring experience

Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment

Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution