Job Description
Job Summary: The Clinical Research Associate II (CRA II) is developing professional expertise, applying policies and procedures to resolve a variety of projects. Involved with more complex tasks and requires a deeper understanding of clinical trial processes, regulatory requirements, and project management. Responsible for clinical studies, site management and compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).
Duties & Responsibilities: - Works on projects of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Exercise judgement with defined procedures and practices to determine appropriate action.
- Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision. An advanced individual may conduct more complicated studies, as well as contribute to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects.
- Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects.
- Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used.
- Effectively work and communicate with investigator, staff and patients in professional, sensitive and mature manner.
- Conduct site monitoring (qualification, initiation, periodic monitoring and close out visits) to ensure and document site is trained to follow study procedures per protocol.
- Monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations.
- Ensure identification and reporting of safety issues (e.g. Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects, etc.).
- Ensure accountability of Investigational Devices and study supplies are performed, when appropriate to the study;
- Perform monitoring activities per Clinical Investigational Plan (e.g. verification of source documents and CRFs, maintain site communications, perform follow up activities on issues noted, etc.).
- Ensure complete reporting and proper documentation of monitoring activities (e.g. complete monitoring reports in a timely manner, follow up with sites to complete open action items, etc.).
- Ensure sites are identifying issues and implementing corrective and preventative actions to ensure inspection readiness.
- Suggest improvements to departmental procedures relating to GCP monitoring aspects.
- Understands and operate Masimo products, data acquisition systems, following best practices for execution of study protocol and use of equipment.
- Ensure essential study documents are accurate, complete, and properly organized and stored as quality records.
- Conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables.
- Writes clear, succinct and detailed clinical study and technical summary reports.
- Conduct full range of data collection duties, including equipment setup and operations, execution of study per procedures, collect data, verify results and transfer data back to Masimo, etc.
- Pack, ship, move, unpack, set up and execute equipment for study at clinical site, and then repack and ship back to Masimo.
- Perform special projects as requested.
Minimum & Preferred Qualifications and Experience: Minimum Qualifications: - 3-5 years experience in clinical studies or related field, including monitoring studies at different phases.
- Experienced with Good Clinical Practice (GCP), FDA, MDD regulations.
- Excellent written and verbal communication skills essential;
- Experience in developing study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs).
- Must be capable of interacting with all levels of management, coworkers, investigators and subjects;
- Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing;
- Ability to independently set and manage multiple priorities;
- Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies;
- Ability to travel to data collection sites, local and domestic, may require up to 25-50% of time;
- Ability to lift and carry up to 20 pounds.
Preferred Qualifications:
- Experience with medical devices;
- Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology);
- Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements;
- Preferably certified as a Clinical Research Associate.
Education:
- Bachelor's degree, preferably in Science or in a related field is required.
- CRA certification training is preferred.
- Combination of education and related experience will be considered in lieu of a bachelor's degree.
Compensation
The anticipated salary range for this position is $69,000 - $90,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.
Physical requirements/Work Environment
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Must be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, repack and ship back to Masimo. Must be able to travel up to 25-50% of the time, both local and domestic (& possibly international), so the ability to operate a motor vehicle and maintain a valid Driver's license is required.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
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About Us For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you'll be part of a culture that's driven by passion, challenging the status quo, and making an impact in the lives of others.
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Job Tags
Work at office, Local area,