Clinical Research Associate - Newmarket, New Zealand - MSD

MSD

Verified Company

Newmarket, New Zealand

1 week ago

Posted by:

Jack Simmons

beBee Recruiter

Description

Clinical Research Associate

Permanent fulltime role with competitive renumeration and benefits

Location: NZL

Auckland
Newmarket
Work with a high performing, agile and passionate team

This role is accountable for performance and compliance for assigned protocols in a country in compliance with country regulations, and our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the Sr.

COM, Head COMs or CRD, the person is responsible for Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.

What You Will Do

Responsibilities include, however 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 indepth 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 onsite 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_.

Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
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.
Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
Supports and/or leads audit/inspection activities as needed.
Performs comonitoring visits where appropriate.
Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities

What You Must Have

Solid prior experience in Clinical Research or experience in Finance/Business
Bachelor's degree or equivalent Health Care related experience
Knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study startup.
Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal support from the Sr.

COM or manager.

Ability to make decisions independently with oversight from Sr.

COM or Manager.

Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. Good knowledge of Good Documentation Practices
Able to work with other experienced clinical research professionals and manage select protocols independently. Works with high quality and compliance mindset.
Problem solving is essential to this position. Requires the ability to proactively identify issues and risks, contribute to root cause analysis, and propose solutions to problems and escalate to management as applicable.

Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.

Effective and efficient time management, organizational and interpersonal skills, conflict management and problemsolving skills.
High sense of accountability and urgency in order to properly prioritize deliverables
Strong communication and negotiation skills as well as developing skills in influencing and training/mentoring, both written and verbal, in local language and English.
Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
Positive mindset, growth mindset, capable of working independent