Associate Cra

**Job Description**:
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The role is accountable for performance and compliance for assigned sites with support of Sr. CRA/CRA and/or CRA Manager. Acts as primary site contact and site manager throughout all phases of a clinical research study. His/her responsibilities include, but are not limited to:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:

- Data generated at site are complete, accurate and unbiased.
- Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Performs co-monitoring where appropriate.

**Travel**

Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

**Competency Expectations**:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- Developing skills in Site Management including management of site performance and patient recruitment
- Developing level of monitoring skill and independent professional judgment.
- Works with high quality and compliance mindset.
- Capable of managing complex issues, solution-oriented approach.
- Ability to perform root cause analysis and implement preventative and corrective action.

**Behavioural Competency Expectations**:

- Effective time management, organizational and interpersonal skills, conflict management
- Able to work with other experienced research professions to develop skills acrossmultiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Positive mindset, growth mindset, capable of working independently and being self-driven.
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

**Experience Requirements**:
Required:

- Min. 2 years of clinical research experience. Related clinical research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

Educational Requirements:

- B.A./B.S. with strong emphasis in science and/or biology.

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