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Senior Clinical Research Associate
Company: INC Research
France, Paris
Ref: EP063-05
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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 :
Sr. Clinical Research Associate
Paris
Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. May serve in Lead CRA role.
ESSENTIAL JOB FUNCTIONS:
COMMUNICATION
•Maintains timely and effective communication among team members and site staff.
•Keeps project leadership apprised of team issues, seeking guidance as needed.
•Participates in Business Development client presentations and bid defenses as requested.
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 and requiring minimal revisions.
•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
•Assists with preparation and attends investigator’s meetings as requested. May present as requested.
•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.
•May assume Clinical Team Lead/ Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training.
RESPONSIBILITIES:
•Performs other work related duties as assigned.
•Demonstrates extensive understanding of SOPs, WI, FDA and local regulations as well as ICH guidelines.
•Demonstrates extensive understanding and knowledge of protocol and disease related terminology for study the individual is currently responsible or under consideration.
•Demonstrated extensive knowledge of the Drug Development process and applies appropriately to studies.
•Ability to handle all aspects of client communication, site selection, site initiation, site monitoring and close out visits 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 four years clinical research experience in CNS, Oncology or Pediatrics and/or other related research experience. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Requires strong organizational, presentation, 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 are 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 of 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 experience in taking the lead
mentoring junior cra's
ICH/GCP |
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