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
The Temporary Clinical Research Coordinator – Virtual is a critical team member supporting all aspects of day-to-day clinical trial activities. The primary roles and responsibilities include planning, coordinating, and managing research activities associated with the initiation and completion of clinical trials in a virtual setting. This role will also be responsible for maintaining compliance with regulatory bodies associated with human subjects research. This open position is a remote-based employee located in the United States with previous research coordinator experience.
Experience developing virtual clinical trial enrollment strategies and enrollment mitigation plans is highly preferred.
Responsibilities and Duties
- Collaborate with research staff to identify, recruit, and enroll eligible patients for clinical trials virtually.
- Collects, maintains, and stores all relevant data associated with clinical research trials.
- Interacts with potential participants to educate them regarding clinical research trials and participant requirements to obtain proper informed consent.
- Conduct all follow-up activities for clinical trials while maintaining and adhering to Good Clinical Practice.
- Ensure patient safety, timely reporting of adverse events, and compliance with IRB approved protocols.
- Communicate with MCRA clinical affairs staff and clients with support of senior MCRA staff, as needed.
- Complete other duties and projects as assigned.
- Ensure all work products comply fully with standards regulations, policies, and mission of MCRA.
Required Knowledge, Skills, and Experience
- Bachelor’s degree or RN
- Minimum three years of experience in clinical research as a research coordinator related to medical devices, drugs and/or biologics.
- Experience with all clinical trial activities within a decentralized clinical trial structure is highly preferred.
- Current certification from a research-related accredited program such as The Association of Clinical Research Professionals (CCRC or similar) is preferred.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Strong research, analytical, critical-thinking, and problem-solving skills.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines.
- PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus).
- Must be punctual, polished and professional.
- Strong client focus and relationship management skills.
- Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
This is an hourly contract/temporary position that will be supporting MCRA DCT clients.
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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