Study Start-Up Coordinator (Secondment - Internal Applications Only)

We’ve got two great secondment opportunities in the PM team!

Off the back of some new study awards, we’re looking for internal applicants to join us for 6 months in a ‘Study Start-Up Coordinator” role.

FOCUS OF THE JOB:   Lead and coordinate the study start-up phase in collaboration with the Project Management and Study Teams, ensuring efficient and compliant initiation of standalone studies or programmes through the effective application of project management principles, methodologies, and processes.

• Provide support to the Project Manager throughout the study start-up phase, contributing to the development and completion of key documentation, including (but not limited to):

1. Study timelines
2. Green Light Checklist
3. Site Activation Checklist (where applicable)
4. Study Plans 

• Set up new studies within internal systems and shared drives, ensuring accurate filing and version control, communicate study awards to relevant team members, and establish and maintain study trackers to support effective oversight of start-up activities.
• Prepare and submit REC and MHRA applications, ensuring all required documentation is complete and accurate, and manage follow-up activities through to final approval.
• Collaborate closely with the Lead Study Coordinator and Lead Medic to ensure all essential site documentation is completed in line with SOPs prior to Green Light and site activation.
• Liaise with the Clinical Research Associate (CRA) in advance of Site Initiation Visits (SIVs) to ensure alignment with study timelines and to support timely and proactive site activation.
• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
• Plan and prioritise own workload, responding efficiently to requests from multiple Project Managers.
• Support the project management team with co-ordinating the study feasibility and site selection process, under direction from the Director of Project Management. 
• To be both a self-motivated team leader and a good team player.
• Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents and any updated or amended regulatory documentation.
• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
• Update and maintain the Trial Master File in a timely manner, ensuring the filing is accurate and inspection ready.
• Work in a self-driven capacity, with limited need for oversight.
• Compliance with MAC health and Safety policy
• Compliance with MAC policy on equality and diversity
• To maintain professional qualifications required for the role, including continuous personal development
• To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
• To work according to MAC SOPs, guidelines and policies
• To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.
• To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out
• To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers