Clinical Research Associate

Medella Life - USA - GENERAL SUMMARY: Under limited supervision is responsible for monitoring assigned clinical research sites to help ensure the clinical trial is in compliance with the currently approved protocol and amendments, with GCP, and with all applicable regulatory requirements. The CRA must be familiar with FDA regulations, ICH GCP guidelines, standard concepts, practices, and procedures related to all phases of clinical trials. Additionally, must rely on experience and possess good judgment to plan and accomplish goals. Must be detail-oriented, demonstrate good interpersonal skills, be flexible and adaptable to changes, and able to manage time well and follow through on problems and commitments in a timely manner. Responds to questions and/or provides information upon request from clients and internal staff. MAJOR DUTIES AND RESPONSIBILITIES: 1. Conduct site visits at various investigative site locations: Site Qualification Visit - to ensure suitability of a site to conduct the study; verifying the PI and research staff qualifications, resources, and facilities are adequate to conduct the trial; provide feedback as to suitability of the site to adequately conduct the clinical trial. Study Initiation Visit - to ensure the site understands all protocol requirements; ensure all required supplies, equipment, and IMP are received and properly stored; to provide GCP training. Interim Monitoring Visit - for the duration of the study which involves visiting the site on a study specified schedule. To review eligibility, AEs/SAEs are documented in compliance with the protocol, concomitant medications, protocol violations/deviations, regulatory documents, pharmacy records, proper administration of the IMP, laboratory processes and records, source document verification, and query resolution. To ensure that the investigator is following the approved protocol and GCPs as well as to ensure the data integrity and that the trial records are accurate, complete and properly maintained. Study Close-Out Visit - to reconcile the regulatory documents, return supplies and/or IMP per sponsor instructions, and provide instructions regarding record retention, financial disclosure, and publication policies. 2. Ensures adherence to study specific SOPs, ICH Good Clinical Practice and FDA regulations; 3. Act as the main line of communication between DP Clinical and the investigative site; 4. Assist Regulatory in collecting essential documents prior to study start-up and maintaining them for the duration of the study; 5. Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the project manager and IRB, as applicable; 6. Prepare reports and letters in accordance with study SOPs; 7. Attend client, vendor, site conference calls; Kick-off meeting; investigator’s meeting and CRA Training meetings; 8. Provide GCP training to site staff and train sites in EDC data entry systems, if applicable; 9. Utilizes tact and experience-based knowledge to resolve problems (clients or staff), explaining specific policies while representing the Company in a professional manner and maintain positive client relations; 10. Must be available for after-hours calls; 11. Performs other Clinical Operations and/or administrative duties as assigned by the CRA Manager. QUALIFICATIONS: Education: College degree in health care, a scientific field and/or in a field directly related to this position. Three (3) years of directly related experience may be substituted for a college degree. Experience/Skills/Knowledge: Minimum 2 year’s previous experience as a CRA or Assistant CRA, or 3 year’s previous experience as a study coordinator. ACRP or SoCRA certification is preferred; Demonstrates working knowledge of medical/scientific terminology and knowledge of FDA regulations and ICH GCP guidelines is required; PC proficient including Microsoft Office (Word, Excel, Power Point, Outlook) and the Internet; Excellent organizational, analytical, and problem-solving skills; Must possess an exceptional attention to detail and ability to produce quality and accurate work in required timeframes; Ability to manage multiple projects/priorities simultaneously and produce the desired results; Ability to work with highly confidential information, take initiative and exercise good judgment; some degree of creativity is needed; Excellent verbal, written, telephone and interpersonal communications skills; Must be conscientious and provide on-time delivery of site visit reports even when under pressure; Ability to exercise self-confidence and diplomacy skills; Ability to be flexible in dealing with changing priorities; Ability to follow-through and react quickly to changing situations; Demonstrated ability to anticipate risks and consequences of current issues on future project outcomes; Must be a self-starter, capable of identifying needs/requirements 14. Must be able to make independent choices and take responsibility for own actions; 15. Ability to work independently and in a team setting; 16. Ability to identify issues, recommend solutions and implement resolutions; 17. Ability to function in a business office environment and utilize standard office equipment including but not limited to: PC, scanner, fax, copier, telephone, etc.; 18. Travel required (50 – 80%). GENERAL DESCRIPTION: In terms of physical requirements, this position requires work best described as: Sedentary Light ?Medium Heavy Very HeavyPHYSICAL TASKS: (Continuous, Frequent, Occasional or Not applicable) Standing/Walking/Sitting/Stooping/ Bending - Continuous Lifting - Able to lift up to 25 pounds - Occasional Hearing - Ability to receive information through oral communication (face to face and telephone) - Continuous Talking - Expressing or exchanging ideas by means of the spoken word (face to face and telephone) - Continuous Reading – Ability to receive information through personal computer, fax, e-mail, and text messages – Continuous Mobility- Ability to travel to multiple locations to discuss problems/issues and conduct orientation as needed - Occasional AUDIO/VISUAL: (Continuous, Frequent, Occasional or Not applicable) Requires vision to perform work dealing with data and figures and computer screens – Continuous Requires ability to prepare and execute presentations, training programs and seminars – Continuous PSYCHOLOGICAL/MENTAL DEMANDS: (Continuous, Frequent, Occasional or Not applicable) Responds positively and productively to stressful customer situations – Continuous Assists others to resolve problems – Continuous... - Permanent - Full-time

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