Study Coordinator Team Lead

Study Coordinator Team Lead - 6 Month Secondment 

Position Purpose:

The purpose of this role is to act in a senior team leader role to support the RM in the mentoring, oversight and recruitment to the team. In addition, plan, coordinates and administers a portfolio of clinical trials as assigned by the RM.  Responsible for managing the project life cycle to ensure effective delivery of objectives.

Line Management Component 

• Manages direct reports (ASC/RA/CDC/CTA/Archivist), including leave, timesheets etc
• Ensures team works cohesively and collaboratively to meet all project goals.
• Works closely with RM to provide leadership, training, mentoring and professional development opportunities to junior team members.
• Works closely with other SC Team Leads to share experience/learnings and resource, as required.
• Works with RM to ensure team resourced adequately.
• Meets with team approximately weekly to update them on upcoming studies and discuss any concerns regarding workload. Escalates to RM as required.
• Reports to RM on any team workload challenges, process improvements suggestions etc.
• Liaises with RM to allocate new studies and allocate SC cover as required.
• Working with team to delegate and prioritise direct reports' tasks. Allocates RA/CDC to SC/studies as required.
• Works with HR and RM to recruit team members as required, including being part of interview panel for new team recruits.
• Orientates new team members, ensures training program in place and monitors ongoing development.
• Acts as trainer to approve competencies on SOPs for direct reports.
• In consultation with RM, identify potential RA for transitioning into ASC role. Provide mentoring for transition to role of ASC.
• Provides feedback to team member regarding performance informally and formally in APR.
• Guides team on issues that require NTF, provides advice regarding CAPA, liaises with QA Manager as required.
• Supports RM with documentation reviews such as SOPs/WPs/templates/NTFs.
• Supports team members with audit preparation and takes part in SSVs etc as requested by RM. Participates in audits as appropriate.
• Reports to and maintains open communications with RM to ensure potential issues are identified and resolved in a timely manner.

Study Coordinator Component 

• Consulting the SC SOPs; ensures all study milestones are achieved for each phase of the study lifecycle.
• Coordinates, plans, and implements the study protocol and monitors study activity with attendance / regular updates at the weekly Operations Meetings.
• Ensures that all activities are carried out in accordance with the study protocol and in compliance with all applicable laws, regulations, guidelines, policies and procedures, SOPs and WPs.
• Acts as primary liaison between PI, investigators, study team, research participants, sponsor, CRA, HDEC and any external vendors.
• Provides feedback on draft protocols.
• If required, works with SUA to submit the online HDEC application including localises ICFs and attends the HDEC meeting as required.
• Submits the ADHB Research office and Māori applications as required.
• In collaboration with the Accounts dept. ensures pass through costs are identified and invoices are appropriately assigned to projects. Also, in collaboration with Accounts dept. ensures subjects are reimbursed in a timely manner according to approved budget/ICF.
• Ensures risks/ issues identified/mitigated and communicated between internal functions/external stakeholders to ensure timely resolution.
• In collaboration with Dept. heads assesses operational and material requirements for studies.
• Reviews the study protocol and other study documents such as the eCRF specification to ensure source documents accurately capture the required source data.
• Coordinates team meetings such as the Planning and Logistics (PaL) to ensure all study specific processes in place and dosing safe to proceed.
• Attends Investigator Meeting locally or internationally as required. Attends regular SC meetings to ensure excellent communication and as a forum to discuss opportunities for improvement.
• In collaboration with the study team co-ordinates the Study Initiation Visit (SIV) and other study related meetings as required.
• Ensures study specific training for key personnel not at SIV is completed and documented. Ensures on-going Amendment training is completed and documented by key personnel.
• Ensures recruitment targets are met where possible and subject safety is always maintained.
• Manages CRA visits and resolves identified issues on the day if reasonable. Once monitoring report received, proactively ensures that action items are addressed in timely manner by relevant NZCR team members.
• Maintains Investigator Site Files to ensure current for monitoring visits.
• Ensures the NZCR Delegation Log is maintained, and all key personnel are delegated responsibility to work on the study by the PI.
• Performs other job-related duties as assigned.

Quality 

• Maintain compliance with all New Zealand Clinical Research standards, protocols, and regulatory requirements, adhering to Good Clinical Practice (GCP).
• Regularly evaluates, documents, and refines clinical and operational processes to enhance accuracy, consistency, and overall quality.
• Assists in training employees in quality standards, policies, and procedures, ensuring all team members understand and implement best practices.
• Ensures accuracy, consistency, and currency in all research documentation and reporting, including accurate record-keeping, version control and timely updates.

Workplace Health and Safety

• Champions a culture of health and safety, ensuring preventative measures are in place to minimize risk to team members and participants.
• Actively identify and report health and safety hazards, accidents, incidents, injuries, and property damage.
• Understands and complies with NZCR's Health and Safety policies and procedures.
• Maintains adherence to all safety standards and processes.
• Commits to personal health and safety at work.

Knowledge, Skills and Experience 

• Knowledge of the ethical principles, procedures and regulatory requirements for clinical research.
• Ability to supervise and mentor new or junior team members.
• Ability to communicate constructively and effectively, both orally and in writing with colleagues and external parties at a variety of levels.
• Skill in organising resources and establishing priorities.
• Ability to foster a cooperative work environment and work effectively as a member of the SC team.
• Ability to analyse, develop, establish and maintain efficient office workflow and administrative processes.
• Excellent organisation and planning skills
• Meticulous attention to detail
• Able to prioritise and enjoy working on several projects simultaneously with tight deadlines.
• Skilled in the use of a networked computer and Microsoft office applications.