What are the responsibilities and job description for the Clinical Research Coordinator II position at Atlanta Center for Medical Research?
About Us :
Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary :
Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Essential Responsibilities and Duties :
- Under supervision, coordinates aspects of patient involvement for complex and / or multiple studies from study initiation until study completion.
- Organizes research information for clinical trials.
- Observes subjects and assists with data analysis and reporting.
- Schedules the collection of data.
- Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
- Monitors, and reports research data to maintain quality and compliance.
- Performs administrative and regulatory duties related to the study as appropriate.
- Participates in other protocol development activities.
- Ensures site receives accurate information and supplies from sponsors (i.e. : source, protocol, scales, supplies, approvals, contacts, etc.)
- Educates potential participants and caregivers on protocol specific details and expectations.
- Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
- Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.
- Assists the CTM in planning, creating processes, trainings and development of staff.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education / Experience / Skills :
Working Conditions
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.