Opportunity to work as Senior Clinical Research Associate at PAREXEL- Apply online before 20th January, 2023

PAREXEL

Website PAREXEL

About PAREXEL

PAREXEL is a prominent global biopharmaceutical service provider that has been instrumental in assisting the Bio-Tech and Pharmaceutical industries in their efforts to develop new drugs and treatments worldwide. The company offers a diverse range of knowledge-based contract research, medical communications, and consulting services across various therapeutic areas to pharmaceutical, biotechnology, and medical device companies on a global scale. Through its expertise and support, PAREXEL has played a significant role in advancing healthcare and bringing innovative treatments to patients around the world.

Post: Senior Clinical Research Associate

Job Description

Start-up (from site identification through pre-initiation):

  • Act as PAREXEL’s direct point of contact with assigned sites, ensuring quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive, and manage country-specific feasibility and/or site pre-qualification and qualification activities.
  • Prepare, negotiate, and facilitate the execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and any amendments.
  • Generate visit/contact reports, identifying and resolving site issues.
  • Develop strategies for IRB/IEC and MoH/RA submissions, site activation, and patient recruitment.
  • Update and maintain Clinical Trial Management systems (CTMS) promptly.
  • Proactively address and resolve site questions or issues.

Maintenance (from initiation through closeout):

  • Assess and ensure overall integrity of study implementation and adherence to the study protocol at clinical sites.
  • Build relationships with investigators and site staff.
  • Evaluate on-site staff assignment accuracy and implement corrective actions.
  • Address and resolve site issues, including additional training and documentation deficiencies.
  • Conduct on-site visits, including Qualification and Initiation visits, resolving site issues independently.
  • Actively participate in Investigator meetings, audits, and regulatory inspections.
  • Collect, review, and approve updated/amended site documentation.
  • Assess and manage test article/study supply, site payment status, and CRF data entry.
  • Perform on-site study-specific training (if applicable).
  • Recognize the impact of study non-compliance/issues on timelines and communicate effectively.

Overall Accountabilities from Site Identification to Closeout:

  • Ensure timely and accurate completion of project goals and update trial management systems.
  • Collaborate with team members to meet project goals and provide efficient project planning strategies.
  • Maintain compliance with ICH-GCP and applicable regulations.
  • Delegate tasks to Administrative Support Team as needed, ensuring audit readiness.
  • Maintain a positive work environment and collaborate effectively with the team.
  • Ensure compliance with SOPs, training requirements, and study-specific procedures.
  • Provide input for Performance Development Conversations.
  • Proactively keep the manager informed about work progress and issues.

Candidate Profile:

  • Substantial Site Management experience in clinical research.
  • Degree in biological science, pharmacy, or related discipline preferred.
  • Strong problem-solving and presentation skills.
  • Ability to work independently, take initiative, and seek guidance when necessary.
  • Client-focused approach, flexibility, and excellent communication skills.
  • Strong computer skills, including CTMS, EDMS, and MS-Office products.
  • Proven ability to make appropriate decisions in ambiguous situations.
  • Ability to work in a matrix environment and prioritize multiple tasks.
  • Willingness to travel as required.

Additional Information

  • Qualification: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred)
  • Location: Bengaluru – Remote
  • Industry Type: Pharma / Healthcare / Clinical Research
  • Functional Area: Clinical Research
  • End Date: 20th January 2023

Please apply by the specified end date.

To apply for this job please visit wd1.myworkdaysite.com.