Clinical Research Coordinator
Northwest Clinical Trials (NWCT) is looking for an experienced Clinical Research Coordinator to join our team. NWCT is an independent, dedicated research facility in Boise Idaho. 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.
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;
- Performing electrocardiograms;
- 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.
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.
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
2+ years of clinical research experience
Proven track record in successful subject enrollment
ACRP or SOCRA certification
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Management retains the right to add or to change the duties of the position at any time.