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Clinical Research Associate
Company: INC Research
Ukraine, Kiev
Ref: EP063-03
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About the Company :
| We are an organization composed of therapeutically-focused high performance teams led by world-class project managers and leaders, dedicated to helping our Customers bring products to market in order to improve world health |
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About the Job :
Clinical Research Associate
Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
ESSENTIAL JOB FUCTIONS:
COMMUNICATION
•Maintains timely and effective communication among team members and site staff.
REGULATORY DOCUMENTATION
•Assures compliance with CFR, State regulations, ICH and GCP guidelines and INC Research and sponsor SOPs.
•Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
•Participates in TMF and on-site audits as requested.
MONITORING
Assumes responsibility for site management and site staff performance including:
•Monitors all types of clinical trials.
•Participates in all types of site visits.
•Assures Principal Investigator (PI) integrity.
•Assures compliance with all protocol requirements.
•Assures effective patient identification and recruitment plan is in place.
•Assures timely reporting of AEs/ SAEs and Protocol Violations.
•Regularly perform Investigational Product (IP) accountability.
•Regularly review the status of contents of the site Regulatory Binder.
DATA HANDLING
•Performs source document verification (SDV) according to contractual requirements.
•Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
•Assures timely and accurate completion of Data Clarification Forms (DCFs).
•Performs clinical data listings reviews as needed.
REPORTING AND TRACKING
•Completes and submits visit trip reports according to SOP requirements.
•Maintains awareness of key study performance indicators for own sites, e.g. patient enrollment, SAEs.
•Updates study and patient status information and serves as (CTMS) resource for PM/LCRA.
•Tracks Investigator payments/ milestones, if requested.
•Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
ADMINISTRATIVE
•Attends investigator’s meetings as requested. May assist with preparation.
•Assists with the preparation of study start up materials and tools, as requested.
•Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.
OTHER RESPONSIBILITIES
•Performs other work related duties as assigned.
•Demonstrated basic understanding of SOPs, WI, FDA and local regulations as well as ICH guidelines
•Demonstrated basic understanding and knowledge of ongoing protocol and disease related terminology for study the individual is currently responsible
•Basic knowledge of the Drug Development process
•Ability to handle most aspects of site selection, site initiation, site monitoring and close out visit with minimal supervision
•Extensive travel may be required (more than 50%).
EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Requires a B.A. / B.S. in the science/health care field, nursing degree, or equivalent related experience. Preferably a minimum of one year clinical or research experience in CNS, Oncology, Pediatrics and/ or other related research experience. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Requires strong organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required. Must have valid, current driver’s license and ability to secure corporate credit card.
PHYSICAL REQUIREMENTS:
Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium weights up to 50 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.
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Profile of Ideal Candidate :
Proven Knowledge of ICH/GCP
Monitoring
EDC
CNS Oncology Infectious Diseases and Peadtrics all advantage |
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 See more opportunities ....
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