Provide technical expertise on safety assessments of adverse events
Key Responsibilities: • Conduct Sponsor assessment of adverse events and device deficiencies reported through clinical studies (e.g. assessment of seriousness, relationship to device and procedure, and UADE (Unanticipated Adverse Device Effect) determinations). Determine what additional information is required for comprehensive assessment and adjudication, when required. Interact with site coordinators and trial managers for the purposes of safety data collection and data reconciliation. • Report adverse events and complaints according to regulatory requirements, trial safety processes and procedures. Respond to related questions from regulatory authorities. • Draft/Design charters and provide oversight of internal and external CEC and DSMB/DMC process. Perform quality assurance of adjudication results and output • Design CEC and DSMB/DMC charters, provide safety/regulatory and medical expertise to Quality Compliance/Complaint Handling on medical aspects of reported complaint information • Prepare or review complex event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions. Review and analyze aggregate safety reports to identify early safety signals and escalate to leadership with recommended next steps. • Create clinical risk/benefit analysis documents to meet internal and regulatory requirements. Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports • Represent safety in cross-functional and core team meetings. Represent safety in internal and external audits • Develop training materials and train and site personnel and safety committees on compliant safety reporting and appropriate support documentation.
Education and Experience: Other: in Physician Assistant (PA) with a Master's degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) or Nurse Practitioner (NP) with a Master's of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent, 8 years experience of combined medical/clinical and relevant industry experience Required or
Other: in M.D, DO or equivalent, 5 year's experience of relevant medical/clinical and relevant industry experience Required
Experience in internal medicine/cardiology/cardiac surgery Preferred
Experience with Medical Device Preferred
Additional Skills: • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with KOLs and clinical personnel • Ability to translate complex and technical information to project team management and key leadership • Recognized as an expert in own area within the organization while applying broad-based technical expertise, and has knowledge of other related disciplines • Expert knowledge of cardiovascular anatomy, pathology and physiology • Expert understanding of principles of regulatory requirements and adverse events reporting • In-depth understanding of corporate/global procedures, standard operating procedures, and writing practices • Leadership skills and ability to influence change • Knowledge of and adherence to Environmental Health and Safety and Quality guidelines • Strict attention to detail • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast paced environment • Represents organization as key medical contact on projects including physicians and clinicians; R&D, quality, RA, etc. • Must be able to work in and help lead in a team environment • Medical liaison with external physicians and clinicians • Provides expert medical input to help provide solutions to difficult technical issues and help drive organizational projects • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
CPRA: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $68.00/hr.
