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.

 Fluent Spanish language skills are required for this position

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.
• Participates in, and contributes to, study teleconferences and/or meetings, as requested. 
• Assists with training of new hire Clinical Research Coordinators. 
• 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.
• Assists with closed study files for archiving in long-term storage.

Competencies: 

• Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets firsthand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.
• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment. 
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities.
• Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus

Qualifications:

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.

Education and Experience:

Bachelor’s degree in scientific or medical related field; advanced level degree is a plus. One year of clinical research experience. CCRC/CCRP certification preferred, but not required.

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.