Clinical Research Coordinator

Beacon Clinic•Post Falls, ID

1d•Hybrid

About The Position

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator (PI) and VP of Clinical Operations on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire Beacon Clinic team, sponsors, and sponsor monitors to ensure compliance with the protocol, ensuring participant is receiving quality and safe care, along with productive and timely data submissions.

Requirements

Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts.
Detail-oriented and meticulous in all aspects of work with the ability to be flexible, organized, detail-oriented and tenacious in follow-through.
Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.
Must have professional demeanor and strong communication skills with the public as well as physicians and researchers.
Ability to work well independently as well as in a team environment.
Must be proficient in Microsoft Office, electronic health systems and databases used in a research environment or have a willingness to learn and demonstrate proficiency within six months of hire.
Possess the ability to work well under pressure, multi-task and manage deadlines.

Nice To Haves

Certification as a Medical Assistant (CMA, RMA, or equivalent) preferred
Experience in clinical research or healthcare setting preferred
Phlebotomy experience required or strongly preferred
Knowledge of Good Clinical Practice (GCP) guidelines
Strong organizational, communication, and patient care skills

Responsibilities

Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) by way of reviewing and acknowledging all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities while utilizing good clinical practice.
Coordinates participant care throughout the research protocol continuum to include, but not limited to prescreening and screening for eligibility, confirming eligibility prior to randomization, consenting, coordination of all necessary protocol procedures and seeking problem resolutions as necessary.
Develops and implements accurate source materials and ensures compliance from all applicable site staff.
Provides accurate and timely data collection documentation, data entry, and reporting in both Beacon’s EMR and sponsors applicable databases.
Reports serious adverse events within 24 hours from site awareness of the event in the applicable data system.
Confirms appropriate credentialing and trainings are complete and current for accurate data capture regarding all study materials such as protocols, participants questionnaires, electronica data capture systems, collection, storage and shipment of specimens, and drug accountability per delegation of responsibility log.
Supports the regulatory staff in the maintenance of regulatory documents, standard operating procedures, and applicable regulations.
Communicates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
Participates with principal investigator and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.
Monitors research participants to ensure visits are appropriately scheduled and include all necessary components.
Updates research calendar and date spreadsheet to ensure it can be used as an accurate communication tool amongst the research team as well as advising when assistance is needed to meet deadlines per contract, compliance, and sponsors/CRO/monitors requests.
Carries out daily operations that contribute to the success of Beacon’s mission to provide an unparalleled patient experience.
Performs Medical Assistant duties as needed, including, rooming patients and preparing them for study visits, obtaining and documenting vital signs, height, weight, and medical history updates, assisting providers with exams and procedures per protocol and clinic standards, performing phlebotomy, specimen collection, processing, storage, and shipment per protocol requirements, administering medications and/or injections as delegated and permitted by scope and protocol.