서울 지역 senior clinical research associate 관련 취업정보

We’re looking for experienced Senior Clinical Research Associates (SCRA’s) to join our amazing Clinical Operations team.

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry, you’ll know that we are experts in our field and you’ll recognise that we’re a growing organisation.

We have a great, employee centric culture and offer excellent long term career prospects. We believe in work / life balance and offer flexible working options for our SCRA’s. We’ve doubled in size this past two years and have promoted 25% of our people in the last 12 months.

The SCRA performs activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Responsibilities

• Conduct site and investigator feasibility activities.
• Develop study-related documents or plans under the supervision of the study Project Manager.
• For a multi-site study, oversee and lead the operations of the clinical team as the Lead CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.
• Perform all activities (preparation, execution and follow-up) associated with onsite or remote Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV).
• Generate and maintain high quality confirmation letters, site visit reports, follow-up letters and other documentation related site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.
• Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, meet with site personnel and ensure procedures are conducted in accordance with the protocol and ICH GCP.
• Perform protocol review as requested.
• Raise data queries in the Case Report Form (CRF) where discrepancies are identified and work with site staff to ensure timely and accurate resolution.
• Collect TMF documentation from site and ensure accurate and timely filing as per SOP requirements.
• Maintain effective site communication to proactively manage on-going study expectations and issues.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
• Provide guidance and mentoring to less experienced staff during co-monitoring visits and facilitating accompanied site visits.

Requirements

• Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field.
• Current or previous experience working as a CRA within a CRO – 4 plus years preferred
• Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
• Clear understanding of the requirement to adhere strictly to client confidentiality.
• Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
• Demonstrated ability to take initiative in problem solving and in exercising good judgment.
• Awareness of Privacy Legislation as it applies to the Clinical Trial environment.
• Ability to work under pressure in a multi-disciplinary team environment.
• Willingness to work in, and be supportive of, a positive and dynamic team culture.
• Ability to travel. Moderate level of interstate travel may be required (up to 50%).

What we offer

• Stimulating work
• Project diversity
• An intellectual challenge
• An agile & flexible workplace
• Opportunity to progress
• Stability
• Sense of community
• A leadership team that are working together on a common goal
• Flexible work options
• Great tools / tech to do your job
• A competitive salary & an extra days holiday for your birthday!

What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.

• To join our team please submit your CV & cover letter as one Microsoft Word document
• You must have full Australian working rights to be considered as we're unable to offer sponsorship for this role.

At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
www.avancecro.com

South Korea, Taiwan