In-House Clinical Research Associate

As an In-House Clinical Research Associate you will serve as the pivotal link between clinical studies and robust clinical data. You’ll support efforts for the implementation and coordination of clinical study sites for in-vitro diagnostic medical devices.

You have an opportunity to play a crucial role in making the latest diagnostic tests and devices available quickly and safely to clinicians and their patients. At MDC Associates, that’s our mission, and we need you to help us meet the growing demand for better clinical tools.

Responsibilities

• Provide general administrative support to CRO Services, as needed.
• Serve as point of contact with study sites during study preparation phase.
• Manage study budget and agreements with study sites and vendors.
• Participate in SDV and study audits, as needed.
• Attend regularly scheduled teleconference meetings with clients during study preparation and throughout studies.
• Assist with Institutional Review Board (IRB) submissions.
• Support project/study CRA in study management according to applicable SOPs.
• Conduct and complete remote site management activities, with support as needed, according to applicable SOPs and Clinical Monitoring Plans.
• Trial Master File (TMF) support on projects.
• Serve as a primary in-house contact for sites and investigators needs throughout study.
• Monitor inventory levels at investigational sites and inform project team of any potential issues.
• Support in maintaining study/project supplies at the MDC office and for study sites.
• Assist and manage invoice reconciliation from vendors.
• Attend project specific and departmental meetings.
• Support in study vendor management.
• Assist CRAs with in-house and on-site activities and queries, as needed.

About MDC

For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients worldwide. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local community’s health. Learn more at www.mdcassoc.com.

By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.

Qualifications

• A phenomenal teammate.
• Bachelor’s degree in health care or other scientific discipline or educational equivalent
• Excellent communication and organizational skills.
• Understanding of ICH GCP Compliance.
• At least 12 months of Clinical Trial Assistant or similar role experience within the clinical/IVD/pharmaceutical industry.

Equal Opportunity Employer

MDC Associates, Inc. is an Equal Opportunity Employer committed to a diverse workforce. MDC Associates, Inc. will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.

Travel Requirements

10-25% Travel including local, within U.S and outside of the US. Travel may include:

• Attending off-site client meetings.
• Attending annual industry conferences (i.e.: ACRP/SOCRA).
• Attending monitoring visits.

Reports To

Clinical Operations Manager

Location

In-Office (Beverly, Massachusetts)

Remote-eligible

Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the North Shore (Newburyport and Rockport lines).

Pay And Benefits

MDC Associates, Inc offers competitive salaries and benefits, including health/dental, HRA, and 401k with a match. We also support an engaging work environment that provides everyone with the opportunity and structure to learn and grow.

• Salary + Bonus
• Group and Voluntary Term Life Insurance
• Medical, Dental, and Vision Insurance
• 401(k) with Match Potential
• Flexible Spending / Dependent Care Accounts
• Short and Long-Term Disability
• Flexible Paid/Sick Time Policy

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