Senior Clinical Trainer – Glasgow HQ, Permanent Opportunity
Clintec is actively recruiting for a Senior Clinical Trainer to join our expanding global company at our Glasgow Headquarters. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The post holder will be expected to design, deliver and evaluate programmes of education and training identified through a variety of processes to include the annual training needs analysis, serious incident reviews, functional requirements and clinical audits. Supported by the Manager, Learning & Development, the post holder will superverse, educate and guide staff in accessing training to fulfil national and local clinical standards and guidelines. The post holder will provide leadership and expert clinical knowledge to a range of health professionals and staff across the company.
Additionally, duties can include helping Clinical Operations identify, select, initiate and close-out appropriate investigational sites for clinical studies; assess & advise on staff monitoring of these sites according to the study protocol, Standard Operating Procedures, all applicable regulations, ICH-GCP, as well as contractual time and budget requirements.
Design, deliver, & evaluate new training programs and materials to a range of clinical and operational staff at various locations across the organization tailored to fit the organisation's and participants' needs.
Provide oversight, coaching and feedback on peer and team member performance to support their development.
Facilitate the organisation's existing staff training & development processes for generating trained employees against industry requirements.
Review the content of training modules and reference materials by seeking the inputs and approval of senior management.
Conduct and/or facilitate training for ClinTec staff as appropriate and justified by experience and expertise.
Coordinates and liaise with the HR department for information on new staff joining the company to facilitate training on ICH GCP and other induction topics as required.
Ensure that an agenda (clear directions and details of venue) and course objectives all course participants are communicated to course participants well ahead of time along with any preparatory work required prior to attending the event.
Co-ordinate the selection and booking of internal/external venues for holding training events/courses and ensuring that all delivery considerations have been addressed (e.g. laptop connections, provisions of screens.)
Keeping data of training materials up to date.
Keeping training records and files up to date, completing and reporting QC reviews of employee training records.
Adherence to Regulatory regulations and laws and ICH-GCP
Supervise and monitor clinical trials to ensure adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures.
Read all applicable SOPs, attend trainings as recommended and maintain an accurate updated training log.
Promote within the team a full and detailed understanding of study protocol, SOPs, ICH-GCP and regulatory matters.
Core Monitoring Tasks and Tracking of Clinical Trials
Assesses CRA performance, quality or compliance problems and escalate as appropriate in collaboration with LM and PM.
Monitor clinical trials to ensure adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures.
Manage study sites to ensure proper adherence to protocol, informed consent procedures, source data verification, compliance to safety reporting procedures and assess CRF entries.
Perform feasibility assessments and pre-study, initiation, interim monitoring and close out visits as required.
Report promptly and in accordance with sponsor SOPs and ICH-GCP and local regulatory requirements any Serious Adverse Events reported by sites to relevant sponsor contact and /or Regulatory Authority contact as appropriate.
Distribute SUSARs (Suspected unexpected serious adverse reaction) in accordance with IEC & local regulatory requirements.
Ensure adequacy of drug shipment and drug accountability (and storage times and conditions are acceptable or and compliance with GMP).
Attend and contribute to Client meetings as and when requested and follow up on assigned actions to completion.
Raise awareness via his/her manager of potential issues.
Provide support to the Project Manager / Country Manager with ad-hoc tasks as required.
Essential Communication and Training responsibilities
Provide oversight, coaching and feedback on peer and team member performance to support their development
Contribute to training activities and cross-functional activities.
Attends diligently all sponsor required team meetings, keeps a log of assigned action items and follows through with their completion.
Identifies and raise with his/her Line Manager training and development needs.
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff, sponsor representatives and CRO’s, vendors, suppliers as appropriate.
Build and maintain relationships with key sponsor contacts, investigators and third parties, ensuring a positive awareness of ClinTec International Services.
Contributes / organise and attends investigator meetings as required.
Contribute to generation of clinical trial related documentation including but not limited to; Protocol, Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists.
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.