Global Kinetics is currently seeking an experienced Senior Clinical Research Associate to work from our Minneapolis office.This newly created role is responsible for managing and meeting the objectives of key clinical studies.Our work environment is fast-paced, with a collaborative atmosphere.Most of all, we are passionate about delivery innovations that transform the quality of health care and the patient experience.We are looking for like-minded individuals to join our team today.
Specific job responsibilities of this exciting opportunity include:
·Supporting Clinical Study Execution;
·General site management, including assisting with the preparation and training of investigators, center staff and internal staff
·Performing data review, monitoring (on-site and remote) and working with clinical study sites to manage regulatory documents and start-up activities;
·Coordinating and conducting monitoring at participating centers to ensure compliance with the protocol and regulations; review monitoring reports and identify discrepancies in reports and study files;
·Support and oversee CROs and vendors;
·Assisting with preparing presentations, writing sections of interim and final reports Clinical Reports as required;
·Assisting with the preparation of materials for CEC and DSMB meetings, as applicable;
·Preparation of study related and training materials;
·Providing input to study budgets and project plans;
·Maintenance of quality and compliance to all applicable regulatory policies and guidance in management of clinical trials.
You possess the following attributes:
Bachelor's degree in related field (engineering, biological sciences or related medical/scientific field).
Minimum of 3-5 years’ experience as a CRA or similar experience in a medical/scientific area is required, preferably in Medical Device clinical studies;
Ability to work effectively with cross functional teams;
High attention to detail and accuracy;
Advanced written and oral communications skills;
Able to manage multiple tasks independently;
Able to identify problems, develop solutions and implement to address study issues;
Proficient knowledge of medical terminology, disease states and current treatment modalities;
Expertise with GCPs and regulatory compliance guidelines for clinical trials;
Knowledge of clinical and outcomes research study design, methods and statistics;
May require up to 40% travel - must be flexible with travel to meet needs of the study;
In-office, Minneapolis-based preferred.
This is a full-time position with competitive salary package and excellent benefits including medical insurance.
To apply, please forward your resume and a cover letter addressing how you meet the above attributes, to firstname.lastname@example.org
FLSA Status: Exempt
Global Kinetics Corporation is an Equal Opportunity Employer (M/F/V/D).
Additional Salary Information: Competitive salary package and excellent benefits including medical insurance
Internal Number: 1
About Global Kinetics Corporation
Recognized as a Top 10 Most Innovative Health Company by the Fast Company Awards 2017, Global Kinetics Corporation (GKC™) is a privately held technology company focused on revolutionising the treatment of Parkinson's disease by providing a market leading innovative digital health technology. The Company was founded in Melbourne, Australia in 2007, and has a growing presence in the US and Europe.
The company's Personal KinetiGraph„ (or PKGTM) is the only commercially available digital health technology which provides clinically validated continuous measurement of the key symptoms of Parkinson's disease. Parkinson's disease affects an estimated 7 million sufferers around the world and is the second most prevalent neurological disease after Alzheimer's.
The PKG system includes a wrist worn device that automatically records motion data. This data is downloaded within minutes, analysed and presented as a medical report that assists clinicians in the evaluation and management of movement disorder symptoms. Clinical studies around the world have repeatedly demonstrated that GKCs decision support information routinely changes clinicians’ treatment decisions approximately 40% of the time, providing valuable input into the ongoing care of Parkinson’s patients.