Vacancies for CRA1 in INC Research Gurgaon

Organization : INC Research
Job Title : CRA1
Location : Gurgaon, India
Qualification :BA/BS degree in the science/health care field or nursing degree or equivalent

Experience : nominal clinical or related research experience some independent field monitoring experience. 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 

POSITION SUMMARY:  

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:

1. 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.

2. 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.

3. 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 performs Investigational Product (IP) accountability.
• Regularly reviews the status of contents of the site Regulatory Binder.
• Resolves problematic issues in a productive way.
• Exhibits effective time management skills.
• Performs observation visits with less experienced CRAs.

4. 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.

5. Reporting and Tracking

• Completes and submits visit reports according to SOP/WI or sponsor requirements and requiring minimal revisions.
• Maintains awareness of key study performance indicators for own sites, e.g. TCRs, 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.

6. Administrative

• Prepares for 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 Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training. 

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