What are the responsibilities and job description for the Clinical Research Assistant position at Pinnacle Clinical Research?
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare.
Be a part of the discovery!
Summary: Assists the clinical research coordinator and the principal investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.
Duties and Responsibilities:
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:
The work environment and 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.
Be a part of the discovery!
Summary: Assists the clinical research coordinator and the principal investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.
Duties and Responsibilities:
- Assists with the creation and completion of study related documents and new study preparation.
- Assists with the completion of regulatory submissions and maintains regulatory files as directed.
- Acts as a secondary liaison with sponsors.
- Assists with the preparation for study monitor visits as directed.
- Completes case report forms as directed.
- Creates reports as requested.
- Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
- Assists with subject screening and recruitment as directed.
- Updates Clinical Trial Management Software (CTMS) as directed.
- Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.
- Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.
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:
- Clinical research certification preferred
- Ability to demonstrate competence in oral and written communication
- Bilingual (English/Spanish) required
- Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor
- Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
- Medical knowledge, including medical terminology
- 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 the organization.
- Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.
The work environment and 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.
- Work is performed in an office/laboratory and/or a clinical environment.
- Exposure to biological fluids and/or bloodborne pathogens.
- Personal protective equipment required such as protective eyewear, garments, and gloves.
- Occasional travel may be required domestic and/or international.
- Ability to work in an upright and/or stationary position for 6-10 hours per day.
- Frequent mobility required.
- Occasional squatting, kneeling, or bending.
- Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
- 401k
- Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
- 3 weeks of paid time off
- 14 paid company holidays
- Tranquility Room (specific locations apply)
- Pinnacle Gym (specific locations apply)
- Scrub voucher (specific positions apply)
- And more!
