Summary: Responsible for administering activities to facilitate clinical research which includes working with affiliate or collaborating research sites by performing the following duties.
Duties and Responsibilities include the following. Other duties may be assigned.
Exercises judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and supervisor.*
Maintains subject and document confidentiality at all times, understands and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.*
Creates and completes study related documents and new study preparation.*
Assists with regulatory submissions and maintains regulatory files.*
Coordinates study related activities with involved parties.*
Acts as the primary liaison with sponsors.*
Prepares for study monitor visits.*
Completes case report forms.*
Types memos and letters related to study activities.*
Creates reports as requested.*
Completes study directed assessments with patients which includes but not limited to informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.*
Performs phlebotomy, specimen processing, and biological sample shipping by using the universal precautions when appropriate and consistent with licensure.*
Performs subject screening and recruitment.*
Interacts with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.*
Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume.*
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.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Ability to add, subtract, multiply, and 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.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Foxfire, web based enterprise solutions software, and electronic case report form systems.
High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.
Certificates and Licenses:
Collaborative Institutional Training Initiative training certification
Good clinical practice training certification
IATA training certification
Clinical research coordinator certification, preferred
Valid driver's license and insurance
Knowledge, Skills, and Other Abilities:
Oral and written communication skills
Ability to pay attention to details
People skills including possessing a positive, friendly, and professional demeanor
Ability to be flexible with changing priorities
Ability to communicate in a diplomatic and professional manner
Good medical knowledge including medical terminology
Knowledge of code of federal regulations, good clinical practices, and International Conference on Harmonization guidelines required
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 talk or hear. The employee is frequently required to stand, walk, use hands, and reach with hands and arms. The employee is occasionally required to sit, stoop, kneel, crouch or crawl, and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.
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 regularly exposed to bloodborne pathogens. The employee is occasionally exposed to work near moving mechanical parts, risk of radiation, and vibration.
The noise level in the work environment is usually moderate.
About Pinnacle Clinical Research PLLC
Pinnacle Clinical Research is dedicated to conducting late phase clinical trials in the areas of Hepatology and Gastroenterology, with a special focus on fatty liver disease. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center.