Associate Clinical Research Associate

Job Description

THE OPPORTUNITY

With support of and/or CRA-Manager acts as primary site contact and site manager throughout all phases of a clinical research study taking responsibility of allocated sites.

WHAT YOU WILL DO

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:

o Data generated atsite are complete accurate and unbiased

o 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 forstudy 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

WHAT YOU MUST HAVE

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 ofsite performance and patient recruitment

Developing level of monitoring skill and independent professional judgment.

Good IT skills (Use of MS office use of some clinical IT applications on computer tablet and mobile devices) and ability to adapt to new IT applications on various devices.

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.

Behavioral Competency Expectations:

Effective time management organizational and interpersonal skills conflict management

Able to work with other experienced research professions to develop skills across multiple 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 selfdriven.

Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Experience and Educational Requirements:

- Associates degree certificate or equivalent in a scientific / healthcare discipline together with at least 3 years of relevant experience in the healthcare field.

Or

- Bachelors degree (or above) in a scientific / healthcare discipline together with at least 6 months of relevant experience in the healthcare field.

or

- Bachelors degree (or above) in a non-scientific/healthcare discipline together with at least 2 years of relevant experience in the healthcare field

Required Skills:

Preferred Skills:

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