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.
- 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.
- 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.
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As an In-House Clinical Research Associate at MCRA, an IQVIA business, you will play a vital role in our dynamic team focused on delivering exceptional clinical trial support for an array of clients. With a rich blend of industry expertise and innovative solutions, MCRA stands out as a leading medical device advisory firm that propels projects from concept all the way through commercialization. In this position, you’ll work closely with the Director of Clinical Affairs, ensuring smooth operation of clinical trial processes while maintaining compliance with Good Clinical Practice (GCP) guidelines and regulatory standards. Your responsibilities will encompass everything from reviewing and approving essential regulatory documents to developing protocol-specific manuals that streamline study operations. You’ll build positive relationships with internal teams and external stakeholders, ensuring effective communication throughout the trial. Your analytical and problem-solving skills will shine as you assist in monitoring activities and support project managers in clinical study planning. If you possess a Bachelor’s degree in a relevant scientific field and have two or more years of clinical trial experience, we invite you to become a crucial part of the MCRA family. Join us and be part of an organization that deeply values integrity, collaboration, and innovation while serving a diverse clientele across orthopedic, cardiovascular, neurology, and other therapeutic areas. With competitive compensation between $70,000 and $90,000 annually, this is an incredible opportunity to advance your career in clinical research and contribute to meaningful healthcare solutions.
MCRA is a leading medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA’s value contribution rests within its industry experience at integrating five business value creators: regulatory, reimbursement, clinical ...
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