Clinical Research Associate
Company: Aesculap Biologics
Posted on: March 18, 2019
Aesculap BiologicsRequisition ID 2019-14186Company Aesculap Biologics# of Openings 1Job Locations USCategory ClinicalPosition Type Regular Full-TimeShift 8am-5pmSite Overview
Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patients lives.
The Clinical Research Associate is responsible for monitoring the collection of study data, including adherence to safety, good clinical practices, study protocol and plans at each research site. This includes training site personnel in proper use of EDC, IVR/IWRS and source documentation and safety reporting procedures. Ability to conduct on-site troubleshooting, provide guidance to study staff, and connect surgeons with questions related to procedures and related problems to experts in an appropriately emergent fashion. Assist in overall conduct of clinical research studies under direction of Clinical Trial Manager.
Responsibilities: Essential Duties
- Assesses site qualification potential; reviews study requirements with prospective sites; conducts site qualification visits; and writes site qualification visit reports
- Conducts site initiation visits; communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel according to Good Clinical Practices and the Code of Federal Regulations; and writes site initiation visit reports
- Supervises the conduct of clinical studies in the field; acts as a liaison between site personnel and the sponsor; performs monitoring visits; ensures compliance with protocols, regulatory requirements, and good clinical practices; discusses subject recruitment and retention; writes monitoring visit reports
- Perform monitoring for safety reporting adherence, data integrity, query resolution, essential document compliance, drug/device accountability, protocol deviations, ensures all required documentation is filed and maintained in the trial master file
- Ensures quality of the project; verifies materials/data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.
- Conduct in-services training and retraining as required to orient all appropriate personnel (investigator and their staff) and support the field staff in the execution of the clinical study
- Verifies the integrity of the investigator site files; jointly reviews with investigators the obligations inherent at the end of the study, write closeout visit reports
- Attends and contributes to the conduct of study surgeon training
- Serves on study project teams; support project team in the management of clinical sites by providing feedback to study team (SM, CAS, CRO or other appropriate party)
- Adheres to Good Documentation Practices; Good Clinical Practices; Good Tissue Practices; and department Standard Operating Procedures
- Must be able to travel (automobile and air transport) and according to Aesculap travel policy
- Must be able to occasionally travel on weekends
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
- Other duties may be assigned
Secondary or peripheral job functions:
- Maintain sufficient records regarding training activities performed at clinical sites
- Contribute to the development/design/updating study source documents and case report forms
- Developing/designing/updating the site training program
- Coordinating clinical supply inventory at site and study levels as necessary
- Clinical data review
- Assist in site and vendor oversight
Language and mathematical skills; reasoning ability:
- Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
- Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- B.S. or advanced degree and/or licensure in medical or life science discipline.
- Three - five years clinical or research experience required.
- Minimum 2 years clinical site monitor experience in device/surgery study and/or orthopedic indication preferred.
- Prior clinical research and familiarity with Good Clinical Practices is preferred. Previous OR or similar clinical environment experience is a plus.
- Site management experience (feasibility, document management, monitoring, query follow-up) is preferred.
- Proficient use and knowledge of Microsoft office required.
- Excellent communication skills In scientific, medical, and social contexts; excellent writing skills
- Must have and maintain valid drivers' license
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its "Sharing Expertise--" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.
Keywords: Aesculap Biologics, Bethlehem , Clinical Research Associate, Healthcare , Bethlehem, Pennsylvania
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