Summary: The Clinical Research Coordinator will be the main operational interface with study subjects during the conduct of a study. The CRC will participate in and manage all administrative aspects of clinical trials under the direction and supervision of the Manager, Clinical Study Management. The ideal candidate will have experience as a CRC at a clinical research site working in the fields of diabetes, metabolism, or endocrinology. Performs duties in accordance with ProSciento’s values, policies, and procedures.
Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.
☐ Additional Duties and Responsibilities for CRC II
All duties defined in level one, and in addition:
☐ Additional Duties and Responsibilities for Senior CRC
All duties defined in levels one and two, and in addition:
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
☐ CRC Education and Experience:
Bachelor’s degree in scientific or medical related field; advanced level degree is a plus. One year clinical research experience. CCRC/CCRP certification preferred.
☐ CRC II Education and Experience:
Bachelor’s degree in scientific or medical related field; advanced level degree is a plus. Two years clinical research experience, with at least one year of CRC experience. CCRC/CCRP certification required.
☐ Senior CRC Education and Experience:
Bachelor’s degree in scientific or medical related field; advanced level degree is a plus. Two years clinical research experience, with at least two years of CRC experience. CCRC/CCRP certification required.
Skills, Knowledge, and Abilities:
Ability to cope with scientific aspects and operational tasks. Leadership and people skills. Ability to work independently. Demonstrates strong initiative and is a problem solver. Thorough knowledge and understanding of GCP as it applies to clinical trials. Knowledge of applicable FDA rules, regulations, guidance documents, and governing conduct of human clinical trials.
Certificates and Licenses:
Clinical Research Coordinator Certification and/or willingness to obtain certification.
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 write speeches and articles for publication that conform to prescribed style and format
Math Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Skills: Ability to define problems, collect data, 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.
Computer Skills: To perform this job successfully, an individual should have knowledge of the current MS Office Word and Excel.
The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The employee must occasionally lift and/or move up to 5 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.