Clinical Research Coordinator Job at Pinnacle Clinical Research PLLC
Come join our team and make a difference as we blaze the way into the future of liver medicine. Pinnacle Clinical Research is dedicated to conducting cutting-edge research with a special focus on fatty liver disease (non-alcoholic). We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Be a part of the discovery!
Summary: Bi-lingual Research Coordinator, 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:
- 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.
- 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 subject screening.
- 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.
Education/Experience:
High school diploma or general education degree (GED); and two to four years related experience and/or training; or equivalent combination of education and experience.
Specialized Training:
- Experience in research and interacting with patients/subjects
- Requires good medical knowledge, including medical terminology
- CITI Training certification
- GCP Training certification
Certificates and Licenses:
- Clinical research certification
- Valid driver's license
- Personal auto insurance
Knowledge, Skills, and Other Abilities:
- Bi-lingual (English - Spanish)
- Demonstrated competence in oral and written communication
- 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
- Must have knowledge of Microsoft Office Word, Internet Explorer, Goggle Chrome, Mozilla Firefox, and web-based enterprise solutions
Work Environment and Physical demands:
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.
Perks of working at Pinnacle Clinical Research:
- 401k
- Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
- 3 weeks of paid time off
- 12 paid company holidays
- Tranquility Room
- Pinnacle Gym
- Scrub voucher (specific positions apply)
- And more!
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
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