Job details
Job type full-time
Full job description
Aesculap biologics
Clinical research associate
Us-
Job id: 2021-19232
Type: regular full-time
# of openings: 1
Category: clinical
Remote (u.s.)
Overview
Aesculap biologics, llc, was established in january 2012 as a division of aesculap, incAnd is focused on biological approaches to the repair and regeneration of diseased or damaged tissuesUsing 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.
Responsibilities
Position summary:
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 siteThis includes training site personnel in proper use of edc, ivr/iwrs and source documentation and safety reporting proceduresAbility 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 fashionAssist 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
Supervisory responsibilities:
N/a
Language and mathematical skills; reasoning ability:
Language skills: ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documentsAbility to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business communityAbility 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 decimalsAbility 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 conclusionsAbility to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Qualifications
Expertise: qualifications-experience/training/education/etc
Required:
B.sOr 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 preferredPrevious 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 hearThe employee frequently is required to use hands to handle or feel and reach with hands and armsThe employee is occasionally required to stand and walkThe employee must occasionally lift and/or move up to 20 pounds.
BBraun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursementTo learn more about bBraun 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, bBraun promotes best practices for continuous improvement of healthcare products and services.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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