Senior Clinical Research Associate

REMOTE

Provident Research Inc. (PRI) concentrates on providing Strategic Staffing, Talent Acquisition and FSP solutions to the Pharmaceutical, Biotechnology, Medical Device and CRO industries.

Our Client, a major manufacturer of medical devices (a subsidiary of a major pharmaceutical and healthcare products company) is seeking several experienced research professionals for its medical devices group. This role is responsible for managing clinical activities at multiple study sites, as well as fostering strong, productive relationships with colleagues within the organization. Here, you'll work in a flexible environment with a close-knit team as you gain exposure to studies across early clinical development to late stage trials.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

If you have at least 5 full years of regional field monitoring,

Provident Research is looking for you!

This opening is immediate due to expansion.

BENEFITS:

This position affords you an opportunity to experience many different aspects of the clinical development industry. Our client is proud to offer a career pathway that looks to internal candidates for promotion.

For the right individuals, this position offers a competitive salary along with:

• Medical, Dental, and Vision
• Disability
• Life Insurance
• 401(k) Plan
• Paid Vacation and Holidays

EDUCATION:

A Bachelor’s Degree is required, preferably with strong emphasis in science and/or biology

EXPERIENCE:

• Previous Regional monitoring required, and all therapeutic experience is welcomeincluding but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and Ophthalmology
• Relevant industry certifications preferred (i.e. CCRA, RAC, CDE)
• Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations
• Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines
• Requires understanding and application of regulations and standards applied in clinical research areas
• Excellent oral and written communication and presentation skills
• Computer literacy and proficiency

Demonstrate competencies in the following areas are required:

• Strong Written and Verbal Communications, including fluent in local languages and English (verbal and written) including the ability to understand and present technical information effectively
• Strong organizational skills
• Ability to travel Regionally up to 65%
• Ability to work independently in a fast-paced environment with changing priorities
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Hands on knowledge of Good Clinical Practice regulations, ICH guidelines
• Proven Skills in Site Management including management of site performance and patient recruitment
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices

Job Activities Include But Are Not Limited To:

• Monitor and maintain ICH-GCP compliance Manages small projects under the direction of a Project Manager/Management as assigned
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Trained to monitor investigational treatment using cytotoxic, targeted, viral, biologic, vaccine and immunologic anti-cancer agents in solid tumor malignancies
• Trained to monitor investigational hematology treatment
• Perform Site Initiation Visits, Routine Monitoring Visits, and Close Out Visits for industry-sponsored clinical trials
• Responsible for all aspects of site management as described in the study plans
• Serve as a lead monitor for a protocol or project as assigned
• Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
• Conduct training visits
• Participate as a presenter for training classes
• Serve as a liaison between study Monitors investigational drug studies in Phases I, II, III, IIIB, and IV

PRI is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

Applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status