Clinical Research Associate - NeuMoDx Molecular Inc - Ann Arbor
Are you experienced in clinical research management? Do you have knowledge of good clinical trial design, and a passion for organization, planning, and administration? If yes, read on!
NeuMoDx Molecular Inc. is a development stage company dedicated to developing vastly superior solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings.
NeuMoDx is seeking a highly motivated individual to serve the role of a Clinical Research Associate (CRA) and be a key member assisting the clinical study team with all operational activities for new and on-going clinical research projects.
The ideal candidate must be results oriented, demonstrate excellent interpersonal skills, and possess strong attention to detail in order to assist in the design, planning, and execution of molecular diagnostic product related clinical evaluations in accordance with all applicable regulations.
- Ensure clinical research projects are conducted, recorded, and reported in accordance with approved protocols, FDA Regulations, ICH-GCP compliance, company SOPs, and client guidelines.
- Assist in the development, review and authoring of study protocols, site specific instructions, investigator manuals, and Case Report Forms (CRFs)
- Train on-site personnel on the use of the NeuMoDx systems and associated tests as well as study protocols including CRF completion
- Effectively liaison with physicians, investigators and study personnel conducting the trial to ensure effective execution of clinical study protocols
- Identify, in a timely manner, issues that could potentially affect study results or on-time completion of study, or any protocol deviation, and suggest means of resolving such issues
- Perform source document verification where required, retrieve Case Report Forms (CRFs) and perform query resolution in a timely manner
- Authoring, filing, and collating study documentation, including all site correspondence, to compile the Trial Master File (TMF)
- Prepare clinical reports and sections of regulatory submissions as well as assist in the preparation of scientific abstracts, posters, and publications arising from clinical research studies
Experience and Qualifications
- Undergraduate degree in a clinical, scientific, healthcare, or related field
- Prior experience in clinical research management in academic or industry setting preferably for in-vitro diagnostic product evaluations is highly desirable
- Working knowledge of good clinical trial design including GCP/ICH guidelines, and FDA regulations
- Proficiency in computerized information systems, electronic spreadsheets, word processing
- Previous laboratory working experience as well as a sound understanding of statistics in desirable
- Can-do attitude with a willingness to go the extra mile to ensure project success
- Excellent communication (written & verbal) and interpersonal skills - including negotiating and ability to build effective relationships with study site staff and colleagues
- Exceptional organizational, planning, and administrative skills/eye for detail – the job involves a lot of documentation and recording of information that must be accurate and thorough
- Ability to prioritize, multi-task, and think on your feet in a fast-past work environment
- Working knowledge of molecular diagnostics is highly desirable
- CRA or CRC certification preferred.
In-house position with possible extensive travel (20-40%) required within U.S. Candidates must be able to work in the U.S. on an unrestricted basis and have a good driving record.
NMDx offers an entrepreneurial working environment and a competitive salary and benefits package featuring, paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.