CRC Level 2

Job Summary

Ensures the safety of our participants. Promotes the mission of PMG to function as an Integrated Site Network. Consistently meets and exceeds priorities as discussed with direct supervisor. Actively recruits and promotes our service to suitable participants and sponsor representatives. Autonomously performs tasks required to coordinate and complete multiple studies according to the protocol and proactively communicates with the Manager of Clinical Operations regarding recruitment efforts and the overall status of the clinical trial(s). Assists the Manager of Clinical Operations and Sr. Clinical Research Coordinators with staff development through mentoring and site level quality assurance.

Job Description

Develops and maintains knowledge and proper skills to comply with the protocol, federal regulatory requirements, internal SOP's and COG's

* Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site

* Proactively develops and executes recruitment plans that meet and exceed enrollment goals

* Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.

* Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.

* Attends investigator meetings

* Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines

* Accurately collects study data via source documents/progress notes as required by the protocol

* Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol

* Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials

* Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events

* Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants

* Dispenses study medication at the direction of the Investigator

* Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits

* Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor