Job description
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: Performs quality checks of data captured (source) and provided to sponsor (EDC/CRF). Ensures that the research site is in compliance with site standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols. Maintains subject and sponsor confidentiality at all times, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, 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:
- Conducts a thorough and precise review of study charts, indicates data points that are missing or discrepant, and identifies and reports any trends to the clinical research coordinator and management.
- Performs periodic quality control review of source documents and EDC/CRF entry on all screen fail files.
- Performs periodic quality control review of source documents and EDC/CRF entry on a minimum of 10% per trial, per review session of enrolled study subjects prior to monitoring visits.
- Works with clinical research coordinators to ensure that data is provided to sponsors and contracts research organizations (CROs) in an accurate and timely manner.
- Establishes timelines with study team for timely resolution of identified action item.
- Prepares for study monitor visits.
- Attends site initiation visits.
- Assists in the creation of memos and letters related to study activities.
- Creates reports as requested.
- Maintains knowledge of CFR, GCP, and ICH guidelines.
- Demonstrates competence in oral and written communication.
- Is organized, attentive to detail, and possesses a positive, friendly, and professional demeanor.
- Remains flexible with changing priorities and is able to communicate in a professional manner.
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
Knowledge, Skills, and Other Abilities:
- 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
- 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.
abouteureka.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, abouteureka.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, abouteureka.com is the ideal place to find your next job.