Summary: The Clinical Research Coordinator will be the main operational interface with study subjects during the conduct of a study. The CRC will participate in and manage all administrative aspects of clinical trials under the direction and supervision of the Manager, Clinical Study Management. The ideal candidate will have experience as a CRC at a clinical research site working in the fields of diabetes, metabolism, or endocrinology. Performs duties in accordance with ProSciento’s values, policies, and procedures.
Essential Duties and Responsibilities willinclude the following. Other duties may be assigned at the company’s sole discretion.
Communicates with study subjects regarding their study status and enrolment into the study.
Schedules subject appointments, performs subject reminder calls, and instructs subjects regarding any medication washout per protocol.
Performs rounds in the clinic to check on subjects and review subject source for completion and protocol compliance.
Reviews protocol for accuracy, logistics, and for training purposes.
Assists with training or managing oversight of training compliance of specific protocol related items for the following departments: screening, recruiting, pharmaceutical services, project management, and clinical operations.
Keeps the Clinical Trial Management System (CTMS) updated with pertinent information.
Responsible for managing study tracking tools, including study information files.
Responsible for completion of logs (informed consent documents (ICDs), training, screen failure, etc.).
Ensures subject study binders are prepared for study visits.
Assists with the review of relevant documents for accuracy.
Assists with review of regulatory binders for completeness and accuracy, as needed.
Administers IRB approved informed consent forms to subjects following Good Clinical Practice Guidelines (GCP), as needed.
Supports staff in day-to-day clinical or administrative activities and procedures.
Supports staff in monitoring and recording subject response to treatment, questioning subjects on adverse events/serious adverse events during study, and completing study specific subject information on serious adverse event form.
Resolves study source document discrepancies including supervising and reviewing completion of documentation of discrepancies by Data Entry Associate or clinical operations staff.
Assists with data entry, as needed.
Attends study teleconferences and/or meetings; may lead, as needed.
Schedules and organizes monitor and sponsor on-site visits, as needed, including setting up pharmacy, lab, and Principal Investigator (PI) meetings with the Clinical Research Associate.
Under direction of the PI, creates Notes to File for clarification around subject related matters.
Participates in study source review and approval process.
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.
CRC Education and Experience:
Bachelor’s degree in scientific or medical related field; advanced level degree is a plus. One year clinical research experience. CCRC/CCRP certification preferred.
Skills, Knowledge, and Abilities:
Ability to cope with scientific aspects and operational tasks. Leadership and people skills. Ability to work independently. Demonstrates strong initiative and is a problem solver. Thorough knowledge and understanding of GCP as it applies to clinical trials. Knowledge of applicable FDA rules, regulations, guidance documents, and governing conduct of human clinical trials.
Certificates and Licenses:
Clinical Research Coordinator Certification and/or willingness to obtain certification.
Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format
Math Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Skills: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills: To perform this job successfully, an individual should have knowledge of the current MS Office Word and Excel.
The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The employee must occasionally lift and/or move up to 5 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.
Internal Number: 1030 and 1005
About ProSciento, Inc.
ProSciento is a leading specialty clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases. Building on 15 years of experience and more than 280 metabolic clinical projects conducted, ProSciento provides customized clinical research services for multinational, early development clinical trial programs designed to give our clients an advantage in today’s rapidly evolving landscape of metabolic drug and device development.
For more information, please visit www.prosciento.com