Under minimal supervision, the scope of this position is responsible for independent research following strategies and tactics formulated in association with senior scientific staff to meet department objectives.
Identifies, selects, initiates, and closes-out appropriate investigational sites for clinical studies. Monitors those sites in order to ensure that studies are carried out according to the study protocol, SOPs, applicable regulations and the principles of Good Clinical Practice. Requires a bachelor's degree in Biology or Chemistry and at least 2 years of experience clinical research. Familiar with standard concepts, practices, and procedures within clinical research. Performs a variety of tasks.
Tasks and responsibilities:
• Carry out assigned functions applying knowledge and skill in an accurate, timely manner.
• Apply knowledge of FDA regulations to site monitoring and clinical study design duties.
• Perform specialized tasks as trained in an independent fashion, requiring minimal ongoing direction. Assist in the establishment of procedures and research methodologies.
• Monitor and maintain necessary supplies, with approval by senior department staff.
• Maintain records of activities and notebooks in a professional, accurate manner.
• Writes summary reports and supports protocol development.
• Apply knowledge of Alere products to effectively train clinical sites before study initiation.
• Travel to clinical sites for training, auditing, and closing clinical sites for Alere-sponsored clinical studies.
• Provide recommendations and observations to senior scientific staff on results of projects/tasks.
• Operate equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations.
• Interact with study coordinators at clinical sites to ensure optimal study progression and resolve problems.
• Accurately enter clinical data into a database and identify errors and discrepancies.
• Learn and apply knowledge of statistical methods to analyze clinical data.
• May functionally direct junior staff as required.
• Initiate literature review and searches to support ongoing research activities. Summarize findings in a final form to senior staff and recommend follow-up actions.
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Perform other duties & projects as assigned.
Preferred educational background:
BA/BS in biology, chemistry or related field with coursework directly applicable to duties. MS in the above fields.
Preferred experiential background:
• A minimum of two years’ experience in the above areas, with particular skills and knowledge of clinical study design, FDA regulations and clinical site monitoring.
• Demonstrated skills in carrying out assignments with minimal guidance in an accurate, effective manner.
• Able to work with a variety of people on multiple tasks.
• May direct junior research staff.
• Excellent oral and written communications.
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook.
• Ability to work within established timelines, in a fast paced environment.
• Excellent organizational and priority management skills.
• Good interpersonal skills and ability to interact at all levels with sensitivity and tact.
• Ability and willingness to travel to other domestic sites 50% of the time is required.