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Job Title: Clinical Research Associate III
Job ID: GEJP00018602
Duration: 12 month contract to start, will extend as needed
Position Title: Clinical Research Associate
The Clinical Research Associate (CRA) partners with Clinical Affairs Project Managers (CAPMs) and other project team members as required to ensure Research is conducted in compliance with Good Clinical Practices, protocol and other applicable regulations and company procedures.
• Partners with CAPMs and other team members to perform initial contact with potential investigators and participates in the assessment and selection of qualified investigators for inclusion in research.
• Performs Qualification, Initiation, Monitoring, and Closeout site visits.
• Tracks required documentation from study site, as needed/required.
• Works with research site personnel to ensure all research activities are run compliantly and according to protocol.
• Perform comprehensive site management activities. Provide high-level consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and GCP/applicable regulatory guidelines.
• Reviews study documentation such as protocols, informed consents, amendments, case report forms and study reports. Offers guidance to study documentation content as requested.
• Reviews ethics committee reports.
• Ensures compliant recording and reporting of any adverse events occurring during research.
• Produce timely and comprehensive visit and status reports. Serve as Subject Matter Expert in the completion of thorough and accurate trip reports.
• Reviews clinical history file for completeness throughout research process.
Quality Specific Goals:
1. Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures. 5.
1. Bachelor's degree (or internationally recognized equivalent) in a life sciences related field or R.N. with a minimum of 2 years clinical research experience, including a minimum of 2 years study monitoring experience, OR minimum of 5 years progressive experience in clinical research to include a minimum of 2 years study monitoring experience.
2. Clinical Research experience such as: study site research coordination or management; sponsor-level clinical research project team experience. Other experience may include investigator qualifications; study monitoring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry.
3. Experience working in multi-site research studies requiring relationship management and prioritization.
4. Ability to travel up to 80% of time for job related responsibilities.
1. Experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate & evaluate deliverables; is well organized and structured, strong attention to detail.
2. Clinical trial professional certification, e.g. CCRP, CCRA or CCRN
3. Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.
4. Knowledge of Quality Management Systems (QMS).
5. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
6. Demonstrated ability to work well independently & in a team setting.
7. Strong problem solving, influencing and negotiation skills.
8. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
9. Experience as a trainer in a clinical environment
10. Experience monitoring all phases of the clinical research process
Thanks & Regards,
Abhipsa Pattnaik (Abhi)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Email: Abhipsa.Pattnaik @artechinfo.com | Website: www.artechinfo.com
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