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Clinical Research Associate
2 months ago
The Research Associate in this position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO). The CTO is an interdisciplinary research unit that provides support for physician-initiated, grant-funded, and industry-sponsored clinical trials.
Key Responsibilities- Recruitment of new study participants to include screening/randomization; management of study documents, regulatory, data entry and as requested assist with unfunded and/or investigator-initiated studies.
- Review studies to develop strategies for enrollment. Schedule pre-site visits, site initiation visits, study start up visits and monitoring visits.
- Ability to work as a team player to include responding to all correspondence in a timely manner and adjusting daily schedules to accommodate both the patient and investigator.
- Keep investigator informed of patient conditions, provide assistance to investigators in the management of adverse events to include changing the workflow to accommodate study amendments and principal investigator directions.
- Serve as patient advocates, scheduling follow-up appointments, coordinate care with other departments, perform all laboratory and other tests as required by the protocol. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies.
- Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs.
- As requested, assist with audit preparation as well as respond to internal audits from the AU IRB Office.
- Must always communicate clearly, convey information in a professional manner which will most often involve sensitive patient data or other information.
- As requested, attend meetings, computer trainings and workshops.
- Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month.
- Responsible for data entry into sponsor's EDC of choice and other data upload systems as well as maintenance of AU OnCore to include updating task lists, entering billing grid information into the financial console, and entering new patients as well as occurring completed visits.
- Perform other related duties as assigned.
- Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research; OR Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience; previous supervisory experience.
- Completion of Citi Program (Learner group 1 FDA regulated research); CCRC, CCRA, or CCRP certification is highly desirable; BLS certification is a plus.
- Proficient in Microsoft Office and other computer software/databases.
- Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong organizational skills.
- Ability to maintain confidentiality. Ability to work early/late hours, nights/weekends and up to two weeks on call a month.
