Clinical Trainer - Clintec, home based in the USA, full time role. Competitive salary offered.
Clintec is currently recruiting for a Clinical Trainer based anywhere in the United States. This role will be homed based full time.
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 work with minimal supervision, to 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.
The post holder will support all activities within the Learning & Development global group and aid facilitation, management, and update of staff training records of all employees within the organisation. 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.
Duties and responsibilities:
Facilitate the organisation's existing staff training & development processes for generating trained employees against industry requirements.
Maintain an accurate updated training log for all training given to employees.
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.
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.
Provides guidance and training assistance to staff who have enrolled in e-learning and other programmes
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. Select and book internal/external venues for holding training events and ensure that all delivery considerations have been addressed.
Compile appropriate questionnaires for evaluation of training events.
Analyse the feedback from questionnaires and present findings to Training Manager and Head of Department along with recommendations for improvements if applicable.
Responsible for documentation of training provision across all functions and training database maintenance.
Contribute to cross-functional activities as requested by functional line manager(s).
In liaison with Training Co-ordinator arrange timely induction and orientation training sessions for all newly recruited employees.
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.
Compile with help of Training Co-ordinator appropriate questionnaires for evaluation of all training events.
Ensuring approval of training supplier/course content is obtained in advance
Analyse feedback from questionnaires and present findings to Training Co-ordinator
Compile monthly status reports of training provision across all functions
Assist with scheduling of training sessions, and booking / notifying all relevant parties.
Taking responsibility for ensuring all training rooms / venues, equipment, and other requirements are booked up or canceled in advance.
Keeping data of training materials up to date.
Printing up of training support materials / handouts for training courses, and assisting with the creation or formatting of these where relevant.
Assisting in training course set up / clear up before and/or after a training event.
Keeping training records and files up to date, completing and reporting QC reviews of employee training records.
Support organisational business needs/requirements as necessary
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
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 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).
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required.
Organise / attend investigator meetings as required.
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.
Perform feasibility assessments & site evaluations as required.
Essential Communication and Training responsibilities
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 and attends investigator meetings as required.
Contribute to training activities and cross-functional activities.
Collate essential study documents from the sites participating in clinical trials.
Help collate site/study documents to enable regulatory approval of clinical trials.
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