Clinical Research Associate - Home Office

We offer an excellent salary, bonus and benefit package, including medical and dental coverage, life insurance, disability, retirement plans, paid holidays and vacations, & flexible work options. Our field sales positions offer a company car & a sales incentive plan which ranks above the competition. TAP is the place you want to be.TAP is an Equal Opportunity Employer.Member of the clinical operations team responsible for conducting Phase I-IV studies according to TAP PPGs, GCPs, ICH guidelines, and other federal regulations. Responsible for total management of at least one multi-center clinical study including overseeing the study team, planning study conduct, writing study protocols, designing CRFs, CRO selection, training and management, , planning and conducting study meetings, and working with the TAP Clinical Monitoring Group or the CRO staff in the evaluation, selection and training of study investigators.Responsibilities Include:
Responsible for conducting studies according to TAP PPGs, GCPs, ICH guidelines and other federal regulations, including writing study protocols, designing case report forms, and writing study reports and summaries.
Responsible for oversight and training of study staff including supervision of contract work.
Participate in selection of CROs. Supervises CROs conducting clinical studies including budget and contract negotiations, training and communicating TAP PPGs and expectations, planning content for study meetings, selection of study investigators, and reviewing trip reports.
Monitor study enrollment on an ongoing basis and work with manager to meet established goals.
Interact with the TAP Clinical Monitoring Group or CROs and Pharmacovigilance to assess adverse events and communicate safety concerns to manager and medical director.
Oversee serious adverse events (SAE) reporting. Liaise with Medical Services when necessary to facilitate consistent SAE reporting.
Coordinate study related meetings and train investigators and site personnel, TAP Clinical Monitoring Staff and/or CRO personnel on the protocol and expectations.
Responsible for calculating, tracking, and management of study budget and financial information.
Responsible for facilitating study classification meeting.
Responsible for co-monitoring of sites with CRO monitor.
Assists with writing abstracts and manuscripts.
Participate in Clinical Committees, as assigned.
Present study related information.Qualifications
Bachelor's degree required (Medical/science/nursing background highly desired).Four years of clinical research experience including two years as a CRA or equivalent required.Experience as a CRA with the TAP Clinical Monitoring Group highly desirable.Experience monitoring pharmaceutical studies or as a clinical research coordinator at an investigative site required.Mentoring experience recommended.Familiarity with TAP R&D data management or clinical systems highly desirable.Must be computer literate and have working knowledge office based management systems, such as MS Office and Lotus Notes.Excellent organizational skills a must.Strong written and verbal communication skills required.Should have some experience with working with medical professionals.Experience with the NDA process desirable.
REQUIREMENTS
Clinical Research Associate