Clinical Research Associate II- Northeast US

What you'll be doing

• Perform monitoring activities (both on site and remote) including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Site Management Contacts, Close Out Visits for Phase I-IV clinical trials, as well as device trials with opportunities to work in the following Therapeutic areas: oncology, pediatrics, rare disease.
• Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
• Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators' Meetings, and complete other project tasks in accordance with study timelines and budget.
• Identify and escalate potential risks and possible retraining opportunities for investigative sites.
• Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high quality trip reports, and active management of all deliverables.

What we are searching for

• Undergraduate degree required or its international equivalent, along with minimum of 18+ months previous on-site clinical research monitoring experience required.
• Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas
• Experience with monitoring oncology/neurology/rare disease/dermatology studies are preferred
• Accountable, dependable and strong commitment
• Ability to meet the requirement of 8-10 DOS (Days on site)/monitoring visits/month; 70-85% travel
• Valid driver's license, passport as required

Pay and benefits

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $80,000 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.