Northwest Clinical Trials (NWCT) is looking for an experienced Clinical Research Coordinator to join our team. NWCT is an independent, dedicated research facility in Denver Colorado. Staff at Northwest Clinical Trials understand the clinical research process and strive to conduct their trials with integrity, attentiveness, and professionalism.
The Clinical Research Coordinator (CRC) assists investigators in the conduct of phase I, IIa, II, III, and/or IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols. Spanish-speaking is preferred but not a requirement.
The Clinical Research Coordinator has partial responsibility for these areas:
Protocol evaluation and feasibility;
Clinical trial preparation involving the planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms and patient recruitment;
Regulatory and ethical submissions and procedures and communicating with relevant authorities
Implementation of clinical trials from initiation, through the stages of development of study documents, communication with study sponsors and/ or CROs, organization of site facilities and staff, implementation of trial procedures, to study completion.
Recruitment and coordination of the trial subjects covering informed consent, screening and evaluating subject eligibility (while adhering to Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols);
Data collection and management, collection of source information, data entry/transcription into Case Report Forms and electronic Case Report Forms, review of subject Adverse Events and Serious Adverse Event reporting, filing and archiving, managing monitoring visits, handling queries;
Close-out of the clinical trial at research site, audit preparation, trial closure, communication with authorities and other disciplines involved;
Investigational product accountability and dispensation;
Greeting patients, completion of registration forms, and give instructions;
Phlebotomy, urine collection for urinalysis, drug screens, and pregnancy tests;
Performing vital signs;
Laboratory sample processing and sample shipping;
Laboratory maintenance (ie, maintaining lab supplies and cleanliness);
Study participant observation (including adverse event/concomitant medication collection and reporting);
Answering phones and scheduling participants;
Maintaining adequate stock of supplies in exam rooms and other conduct areas;
Following appropriate legal and ethical professional conduct
Assisting with other duties as assigned.
Work is performed under general supervision from the principal investigator of the research unit or managing delegate.
Must be familiar with all medical diagnostic equipment used in the Clinical Research Unit.
Work is performed in an office, laboratory, and/or clinic environment.
SCHEDULED HOURS PER WEEK:
Full Time-40 hours
Position requires a BS/BA in a biomedical field or equivalent combination of post secondary education, medical certification, medical licensure, and/or at minimum 2 years healthcare experience. Position requires CRC or CRP Certification or willingness/ ability to obtain certification.
2+ years of clinical research experience
Proven track record in successful subject enrollment
Northwest Clinical Trials is a dedicated medical research facility in the heart of Denver, Colorado. We provide critical data to pharmaceutical, biomedical and medical device companies. NWCT’s broad range of clinical expertise includes Dermatology, Cardiology, Gastroenterology, Endocrinology, and more. Our early phase capabilities include all of these therapeutic domains, plus: CNS, infectious Disease, Women’s Health, Men’s Health, Pain, Rheumatology, Smoking Cessation, Vaccines.