Clinical Research Associate

7 months ago

Thane District Maharashtra, India Ibhaan Pharmaceuticals Full time

Act as the company’s direct point of contact with the assigned sites, accountable for quality and delivery during all the phases of the study (Start up, Initiation through closeout)

Build relationships with investigators and site staff

Preparation, negotiation and facilitation of execution of Confidentiality Agreements, Clinical site agreements and any amendments

Generate visit or contract reports, using judgement to identify site issues and problem solving to direct resolution

Customize, review and negotiate as needed, site specific ICFs, translations & customise and negotiate any amendments

Submit all pertinent documentation to the TMF as per project plan

Forecast, develop, manage and revise plans and strategies for EC submission, regulatory submission and approval, site activation, patient recruitment and retention

Actively participate in Investigator and other external or internal meetings, Audits and regulatory inspections, conduct on site study specific training if required

Work in a self-driven capacity with limited need for oversight, Show commitment and perform consistent high quality work

Proactively keep manager informed about work progress and any issues

Address and resolve any issues at site including the need for additional training potential deficiencies in documentation and communication

Perform on site visits [site feasibility, site initiations through closeouts] and generate visit reports

Assess and manage IP supply including supply accountability, destruction/return status

Review and follow up site payment status

Follow up on CRF data entry/query status and SAEs

Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, encourage the support of team members were required

Update all appropriate clinical trial management systems on an ongoing basis, perform regular reviews of site level data, ensure timely and high quality data entry & compliance from sites, manage and submit all relevant documents to the trial master file, ensuring first time quality and distribute study documents to site including configuration of Investigator site files if applicable and ongoing maintenance for completeness and quality

Ensure that assigned sites are audit and inspection ready

Monitor and maintain compliance with ICH GCP and applicable international and local regulations

Maintain a positive result oriented work environment, building partnerships and collaborative relationship, communicating with team in an open balanced objective manner thus modelling high performance culture values

Maintain a working knowledge of and ensure compliance with applicable ICH GCP guidelines, international and local regulations, companies sops, sponsor’s training requirements, study specific procedures plans and training

Ensure basic understanding of project scope, milestones, budgets and study for high quality timely and efficient delivery

Complete additional tasks in a timely manner

**Job Types**: Full-time, Permanent

Schedule:

- Day shift

Ability to commute/relocate:

- Thane, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

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