The Human Resources Representative is responsible for performing HR-related duties on a professional level. This position carries out responsibilities in the following functional areas: benefits administration, employee relations, training, performance management, onboarding, policy implementation, recruiting, affirmative action and employment law compliance. This position will also be responsible for payroll and some office management duties.
MAJOR DUTIES AND RESPONSIBILITIES
Plan, direct, or coordinate clinical research projects. Provide technical product advice to sites. Case coverage, proctoring or technical support assistance for patient NeoCart implants procedures within the clinical environment. Train on and maintain knowledge of clinical trial protocols, Clinical Department standard operating procedures, and compliance toward the regulations of world-wide regulatory bodies. Provide technical support for clinical trial procedures including implant utilization and any follow up visits. This includes direct patient contact if required in the clinic setting. Train and maintain knowledge of products, anatomy and physiology, standard operating procedures, and compliance toward the regulations of world-wide regulatory bodies. Report NeoCart implant issues immediately as per policy. Maintain composure in complex clinical situations. Integrate seamlessly with providers, clinicians and facilities. Coordinate and perform monitoring activities as related to the conduct of all phases of biotechnology clinical trials, and serve as primary point of contact and support for site from start-up through study close-out. May perform remote visits and/or on-site visits in accordance with the study Monitoring Plan, including oversight of site recruitment and consenting process. Maintain communications on a regular basis with the investigator and site study staff. Train investigative site personnel on protocol and procedures. Coordinate and attend ongoing study training. Complete visit reports, confirmation letters, and follow up letters on time, in accordance with Monitoring Plan and/or Histogenics SOPs and Guidelines. Site compliance reporting of Serious Adverse Events (SAEs) and protocol deviations. IND safety report management (e.g. MedWatch, CIOMS, SUSAR), as applicable. Support the implementation of Corrective and Preventative Action (CAPA) items, with minimal supervision, through resolution and implementation in a timely manner. Resolve open action items, for assigned sites, including those identified from site monitoring visits. Perform query resolution activities through completion in collaboration with DM. Collect, maintain, and track essential regulatory documents, post site transition, on an ongoing basis, including expired documents and updated or amended documents. Maintain ongoing communication with study team and field monitors. Distribute amended study materials, such as protocols and ICFs, to sites and manage associated LIRB/CIRB and ICF activities. Perform assessment and co-monitoring visits as needed. Requires 50% of travel to various unanticipated locations throughout the US and Canada.
Education and Experience Required:
Requires Master’s degree in Chemistry or Regulatory Affairs, plus at least 2 years of experience in job offered or alternate occupation of Clinical Research Associate (any level accepted). In lieu of Master’s degree plus 2 years of experience, employer will accept a Bachelor’s degree plus 5 years of post-bachelor progressive work experience in job offered or alternate accepted occupation. Employer will accept any suitable combination of education, training, and/or experience.
Requires two (2) years of experience in: Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP); Monitoring or operating room/medical device management experience and clinical monitoring examination; Searching medical literature and databases for clinical and technical information; Experimental design; Computerized databases for the maintenance of scientific data; FDA and international regulations concerning the conduct of clinical studies; and Statistics and statistical methods.
To apply, mail your resume and cover letter (Reference job title and job location in cover letter) to:
Attn: Carly Burns
830 Winter Street, 3rd Floor
Waltham, MA 02451