Clinical Research Associate

Location

Ann Arbor, MI | United States

Job description

NeuMoDx Molecular Inc. is an innovative medical device 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.

Responsibilities:

Ensure clinical research projects are conducted, recorded, and reported in accordance with approved protocols, FDA Regulations, ICH-GCP compliance, company SOPs and client guidelines

Effectively identify and liaise with physicians, investigators and study personnel conducting the trial to ensure effective execution of clinical study protocols

Conduct on-site visits and complete associated reports for site qualification, site initiation, interim monitoring and site closeout, which will include the following:

Train on-site personnel on the use of the NeuMoDx Systems and associated assays as well as study protocols, including CRF completion, event reporting, etc.

Perform source document verification where required, retrieve Case Report Forms (CRFs) and perform query resolution in a timely manner

Author, file, and collate study documentation, including all site correspondence, to compile the Trial Master File (TMF)

Identify, in a timely manner, issues that could potentially affect study results or on-time completion of the study, or any protocol deviation, and suggest means of resolving such issues

Assist in the development of the clinical research infrastructure including standard operating procedures, work instructions, templates and forms applicable to on-site visits

Support the compilation effort of clinical related data to the FDA and EU regulatory bodies

Experience and Qualifications:

Bachelor’s degree (minimum) required in a clinical, scientific, healthcare, or related field

A minimum of 3-5 years as a clinical research associate conducting on-site visits, preferably for in vitro diagnostic product evaluations. Will consider a work history involving IVD lab experience along with pharmaceutical or medical device field monitoring.

Working knowledge of GCP/ICH guidelines and FDA regulations

A sound understanding of statistics and clinical trial design is desirable

Can-do attitude with a willingness to go the extra mile to ensure project success with minimal oversight

Excellent written and verbal communication, as well as 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 – responsibilities involve heavy documentation that must be accurate and thorough

Ability to prioritize, multi-task, problem solve and think on your feet in a fast-paced work environment

Working knowledge of molecular diagnostics is preferred

CRA or CRC certification preferred

In-house position with extensive travel (40-50%) required within U.S. and possibly internationally. Candidates must be able to work in the U.S. on an unrestricted basis and have a good driving record. Relocation package not available.

NMDx offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, life & disability insurance, and medical/dental plans.

For consideration, please submit resume along with salary requirements to [email protected] and mention the job description in the subject.

Job tags

Salary