Acelity Careers

Senior Clinical Research Associate

San Antonio, United States of America
Science and Engineering

Job Description

The Senior Clinical Research Associate (senior CRA) supports in the set-up, execution and closure of a clinical study conducted and/or managed by Acelity. The Senior CRA monitors the progress of the clinical studies; verifying that the rights and well-being of human subject’s safety are protected and the conduct of the trial is being carried out in accordance with state and federal regulations, guidelines, standard operating procedures and other applicable regulatory requirements.

Major Responsibilities:

Serves as primary point of contact for assigned clinical studies between Acelity, investigators and the investigational sites
Supports the development of protocols, Informed Consent Forms, data collection tools and other study specific documents necessary for the appropriate implementation and conduct of clinical studies
Participates in the identification of potential sites and Investigators; performs site qualification visits
Supports with the creation of study specific Monitoring and Communication plans, as appropriate
Supports with creation and tracking of site budgets/payments
Performs the preparation and submission of notifications/submissions to IRB
Ensures that the rights and well being of human subjects are protected and that the reported data are accurate, complete and verifiable from source documents
Ensures accurate accountability of all study related products
Conducts investigator/site training
Conducts site visits as required – site qualification, initiation, interim, and close-out visits including writing of site visit reports
Supports and is involved in the organization of investigator meetings
Ensures timely, accurate collection of (Serious) Adverse Events, (S)ADEs and/or complaint reports and follow up
Follow up, resolve and report issues identified during clinical trial activities
Maintains study specific files for assigned projects
Participates in the development of departmental procedures, demonstrating knowledge of clinical trial processes

Basic Qualifications:

Bachelors degree in Life Science, medical or related field
At least 5 years of clinical study experience
Minimum of 3 years functioning in a role of a field CRA
Experience with Microsoft Office applications including: Word, Excel, PowerPoint & Outlook

Ability to travel both domestically and internationally (up to 50-75%)

Preferred Qualifications:
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
Experience using EDC and CTM systems

Ability to work independently and exercise sound judgment
Knowledge of medical terminology/therapeutic area specialty
Have a broad understanding of clinical trial processes
Ability to determine when to involve appropriate team members for decision-making
In –depth knowledge of ICH-GCP and applicable federal regulations
Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude
Analytical and accurate
Excellent verbal and written communication skills
Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment

Additional Information:
This position is office based.

The information listed in this Job Description is not a comprehensive list of all duties/responsibilities performed.

This Job Description is not an employment agreement or contract.  Management has the exclusive right to alter this position guide at any time without notice.

The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description 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. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: VEVRAA Federal Contractor