MCRA 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 1100 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.
Position Overview
MCRA is seeking a Clinical Research Associate to be a critical member of the clinical operations team. The Clinical Research Associate will be responsible for management of assigned investigator sites and all monitoring activities for assigned studies. Clinical affairs duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
Position Responsibilities
- Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.
- Conduct on-site and remote study monitoring and site management.
- Assist project manager with clinical study planning and management, as required.
- Assist Clinical Trial Manager with drafting protocol-specific manuals, plans, and documents as needed.
- 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.
- Verify site qualifications and capabilities to conduct clinical studies.
- Assist Clinical Trial Manager and In-House CRA with ensuring that Trial Master File is accurate and complete throughout the lifecycle of the project.
- Prepare and conduct 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 developments in the assigned therapeutic areas.
Qualifications
- Bachelor's degree (B.A./B.S.) in life sciences, healthcare or a related scientific discipline or Registered Nurse/Allied Health Professional with clinical research experience.
- 2+ years of clinical research experience required
- Minimum of 1 year of direct, on-site clinical trial monitoring experience required
- Medical device experience is a plus
- Knowledge of ICH guidelines for GCP
- Knowledge of clinical monitoring procedures and best practices
- Experience using Electronic Data Capture (EDC) and clinical trial management systems
- Strong written and verbal communication and presentation skills
- Strong research, analytical, critical-thinking, and problem-solving skills
- Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications
- Ability to read, write, speak, and understand English
Special Requirements
- Travel (75%) required for this position
$75,000 - $100,000 a year
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, LLC 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.
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