What are the responsibilities and job description for the Clinical Operations Manager position at ALLIANCE CLINICAL LLC?
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.1) Comply with all company policies, procedures and conduct.2) Strictly adhere to confidentiality and compliance standards.3) Manage and train clinic site personnel.4) Read, comprehend and communicate study protocols.5) Manage back office staff personnel.6) Oversee SIB, PSV and IMV.7) Manage and facilitate study startup documentation, training, supplies and timelines of study protocols.8) Work closely with CRO/CRA/IRB. 9) Collect and document patient medical history and informed consent.10) Accountable for study drug dispensing.11) Collect and evaluate concomitant medication.12) Collect A/E and SAE.13) Perform EKG, vital signs, and protocol specific procedures.14) Collect and process blood, urine and tissue samples.15) Maintain site regulatory files.16) Document temperatures for IP stored on-site.17) Recruit and engage study participants as needed.18) Audit study e-source documentation to comply with study protocols.19) Other tasks as assigned.QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EDUCATION and EXPERIENCE:1) Associate’s degree in healthcare or equivalent experience, required.2) 5 years’ experience in clinical research; required.3) 3 years' experience working as a Clinical Research Coordinator, required.4) Comprehensive knowledge of FDA, GCP & confidentiality.5) Proven success in managing teams and working in direct patient care, required.6) Proficient problem solving skills & conflict resolution.7) Proficient in Microsoft Word, Excel and PDF.8) Excellent verbal and written communication skills.9) A proven ability to constantly prioritize multiple projects in a rapidly changing environment.10) Must be comfortable with a rapid-growth company.
Salary : $95,000 - $105,000