Job description
Position Overview
This position is part of the Clinical Affairs team, which is responsible for planning, executing, managing, and closing clinical studies associated with the company’s research needs. The Clinical Affairs Training Specialist will partner with the Clinical Affairs Leadership Team and the Clinical Quality Assurance team to ensure staff within all appointed departments are properly trained and compliant with ongoing training and associated documentation. The Clinical Affairs Training Specialist will assist the Clinical Quality Assurance team to ensure the project team’s adherence to quality and compliance standards.
Essential Duties
Include, but are not limited to, the following:
- Serve as the primary facilitator of training for appointed department team members.
- Collaborate with leadership teams in the design and development of training material and role-based training concepts.
- Plan, organize, develop, and direct a wide range of training activities including classroom training, electronic learning, and other computer-aided instructional technologies, conferences, and workshops.
- Partner with Clinical Quality Assurance team to ensure adherence to GCP, appropriate regulations, SOPs, and business processes.
- Collaborate with the Exact Sciences Quality Systems Specialist to ensure training is developed and documented per existing corporate SOPs.
- Identify and develop new strategies to effectively train staff.
- Assess the impact of the effectiveness of the training courses through participant feedback and knowledge checks.
- Collaborate with department leadership team to develop and implement training strategies that address performance gaps.
- Draft, review, and revise Clinical SOPs as assigned and assess consistency across internal training, current processes, GCP, and applicable regulations.
- Partner with CROs, vendors, and external collaborators to assess and maintain training compliance.
- Incorporate findings from audits and corrective action and preventative action plans, if applicable, into new and revised processes and training for appropriate departments.
- Collaborate with department team members to develop and document study-specific training.
- Assess clinical training plans at department and study level for completeness.
- May be expected to lead and/or support other initiatives and programs.
- Ability to frequently and accurately communicate with colleagues, customers, and vendors in person, via the telephone, or by email.
- Ability to manage multiple deadlines.
- Comfortable with public speaking and leading a classroom. Virtual and technical skills required to conduct courses with remote employees (e.g., WebEx/Skype training sessions).
- Adept at planning and prioritizing work to meet commitments aligned with organizational goals.
- Apply strong verbal and written communication skills.
- Apply effective presentation skills.
- Ability to interface and work effectively within a team and department with changing priorities.
- Apply excellent attention to detail and organizational skills.
- Ability to work independently.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to work designated schedule.
- Ability to lift up to 10 pounds for approximately 5% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s degree in the health or life sciences field.
- 3+ years of experience in a clinical research setting or related capacity.
- Thorough knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
- Experience in using basic software applications including Microsoft Office (Word, Excel, PowerPoint, Outlook), Microsoft Visio, and various search engines for conducting internet searches.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
- 2+ years of training experience.
- Experience in a healthcare, clinical, or science related field.
- Experience with CTMS, EDC, eTMF, and sample management systems.
- Experience with curriculum development.
- Experience in IVD studies and lab site management.
- Experience in end-to-end trial activities including feasibility, start-up, study conduct, close-out, data management, and report writing of clinical studies.
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If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email
jobs@exactsciences.com
.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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