Site Educator
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.
RESPONSIBILITIES
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including: Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data
- Attend all relevant study meetings and review meetings for Site Requirements
- Good command of English / French/ Arabic is a must for Morocco as all study documents are in English but French& Arabic are the local spoken languages
- Good knowledge of clinical research and Good clinical practice certification is a must
- Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research
- Assess site to be in line with GCP.
- Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
- Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records
- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies
- Assist research site with coverage planning related to staffing and scheduling for research projects
SKILLS
- Knowledge of clinical trials: In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Knowledge of medical terminology
- Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
- Excellent interpersonal and communication skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
EDUCATION AND EXPERIENCE
- Degree in life sciences or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experience
- Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies
- Extensive experience as a Senior Clinical Research Associate
PHYSICAL REQUIREMENTS
- Use of telephone and face-to-face communication requiring accurate perception of speech
- Use of keyboard requiring repetitive motion of fingers
- Frequent mobilization around the facility
