CRO-Contract Senior Clinical Research Associate

Job Description Job Title: Contract Senior Clinical Research Associate Department: Monitoring Location: Utah PURPOSE The Contract Senior Clinical Research Associate (CRA) conducts site monitoring responsibilities for clinical trials, according to Standard Operating Procedures (SOPs), FDA regulations, ICH guidelines, and Good Clinical Practices (GCP). ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Contractor performs all, part, and/or any combination of the duties listed below. - Independently manages and monitors site activities for assigned clinical studies, working individually or co-monitoring with other CRAs. - Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits. These visits will be completed independently. - During monitoring visits, the CRA ensures compliance with the protocol and applicable Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines. - Independently and proficiently performs site evaluation visits of potential investigators. Thoroughly evaluates the site’s capability to successfully manage and conduct the clinical study. - Expertly and independently performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities. - Ensures the Investigator Site File is kept audit-ready and ensures documents are collected and uploaded into the Trial Master File on a regular and timely basis. - Has direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management. - Independently documents accountability, stability and storage conditions of clinical trial materials as required by the Monitoring Plan. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. - Serves as primary contact with the site; coordinates all correspondence; ensures timely transmission of clinical data with the study site. - Expertly and independently performs study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. - Ensures internal and study-related trainings are completed per Lotus and/or study timelines. - Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan for Confirmation Letters, Follow up Letters and Monitoring Visit Reports. - Performs other related duties as requested. SUPERVISORY RESPONSIBILITIES Position does not require direct supervision over other team members; however, position may require collaboration with the CRA Line Manager to support the mentoring, training, and assessment of CRAs and junior staff as applicable. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Ability and willingness to travel up to 100% of the time (land and air), both domestically. The requirements listed below are representative of the knowledge, skill, and/or ability required. EDUCATION and/or EXPERIENCE Bachelor's degree or equivalent experience in life science/healthcare is required accompanied by at least 5 years of field experience working within clinical research as a CRA. Mastery of the CRA II Job Responsibilities. Valid Driver’s License. Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency. SKILLS and/or ABILITIES Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process. Proficiency in using elec