In-House Clinical Research Associate

MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA’s value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

The In-House Clinical Research Associate will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm’s clientele. Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. The In-House CRA will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

Responsibilities

• Review and approve research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials
• Review clinical protocols to ensure collection of data needed for regulatory submissions
• Contribute to protocol-specific manuals, plans, and documents as needed
• Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan
• Assist project manager with clinical study planning and management, as required.
• Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
• Assist in the identification and recruitment of potential investigators and study sites, as needed.
• Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
• Assist with site training for assigned clinical trials.
• Assist with site audits and site quality management activities as needed
• Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas

Required Qualifications

• Bachelor’s degree (B.A./B.S.) in pharmacy, pharmaceutics or a related scientific discipline
• 2+ years of clinical trial experience. Monitoring experience preferred.
• Comprehensive knowledge/ fluency of GCPs and clinical monitoring procedures
• Understanding of therapeutic area for assigned clinical projects.
• Experience using Electronic Data Capture (EDC) and clinical trial management systems
• Possesses strong written and verbal communication and presentation skills
• Strong research, analytical, critical-thinking and problem solving skills
• PC/Technical skills – MS Office, Excel, Word, PowerPoint (Endnote experience is a plus)

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.