Summary: Under the supervision of the Associate Director, CRA Services, conducts site monitoring for clinical research studies according to ProSciento Standard Operating Procedures (SOPs) and ICH/GCP/GLP guidelines. Prepares monitoring reports and assists with query resolution. Performs duties in accordance with the company’s values, policies, and procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned at the Company’s sole discretion.
If applicable, a company credit card may be issued and must only be used for reasonable expenses incurred on the company’s behalf (e.g. to arrange travel, book hotel, car rental, taxi, and purchase food).
☐ Additional Duties and Responsibilities for CRA II:
All duties defined above, 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.
Senior CRA only: May oversee contract CRAs or serve as Lead CRA for a multi-center project.
☐ CRA II:
Skills, Knowledge, and Abilities:
Ability to independently and accurately perform clinical data review of source documents and case report forms. Ability to follow study specific guidelines, plans, and manuals, and participate in all aspects of training in addition to performing verification and resolution of data queries/discrepancies within defined timelines. Ability to understand and follow oral and written instructions precisely. Solid communications skills, with co-workers, investigative site, and sponsor/vendor representatives required. Ability to work in a fast-paced environment and adapt easily to changing priorities.
Ability to speak, read, understand and write English. Ability to read and interpret scientific journals, study protocols, investigator brochures, study manuals and ancillary documents such as SOPs and equipment and laboratory procedure manuals. Possess the ability to write routine reports and correspondence, and to speak effectively before groups of customers or at sites.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Possess the ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Possess the ability to deal with problems involving several concrete variables in standardized situations.
To perform this job successfully, an individual should have knowledge and proficiency in the current Microsoft Office Suite.
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.
While performing the duties of this job, the employee is occasionally exposed to outdoor weather conditions. 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 the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to stand, walk, stoop, kneel, crouch, or crawl.