CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CPI (Certified Principal Investigator), CCRP (Certified Clinical Research Professional), CIP (Certified IRB Professional), RAC (Regulatory Affairs Certification), CCDM (Certified Clinical Data Manager), RQAP-GCP (Registered Quality Assurance Professional – GCP), PMP (Project Management Professional)
4 Year Degree
This position is responsible for assisting in the development, planning and implementation of clinical research projects in accordance with good scientific principles and pertinent government regulations. Assists the Manager, Clinical Research and Sr. CRA in the oversight, design, planning and development clinical evaluation projects. Assists in the design of experimental protocols and patient record forms. Assists in the preparation of clinical protocols and conducts clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Routinely monitors the clinical sites and the results of clinical investigations in preparation for new-drug or device application.
RESPONSIBILITIES: include the following. Other duties may be assigned.
Assists in the preparation of protocols and documents for clinical studies, entailing communication with consultants such as surgeons, radiologists and outside statisticians.
Assists in the coordination of activities of investigators and clinical site personnel to ensure compliance with protocol and overall clinical objectives.
Assists in the coordination of internal and external resources in the conduct of clinical studies in accordance with good scientific principles and pertinent government regulations.
Communicates with study team to ensure that clinical studies are kept on schedule.
Travels to clinical sites to perform study initiation, interim and close-out monitor visit. Reviews records and procedures to assure adherence to established protocols.
Generates and reviews clinical monitoring reports.
Assists in the training of investigator and clinical study personnel.
Assists in the coordination with other business units to prepare materials to present at investigator and general clinical meetings.
Assists in the overall data management such as case report form design, edit check review, data clarification process and evaluating and analyzing clinical data for quality and accuracy.
Assists in the review of adverse events and prepares reports for medical reviewer.
Maintains a high level of professional expertise through familiarity with clinical literature and leads project team meetings.
Obtains IRB/EC approvals and prepares, reviews, and approves progress reports for clinical studies.
Prepares and reviews documents for obtaining product or study approvals such as IND’s or IDEs.
Assists in various projects as assigned.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree and five to eight years’ experience in clinical trials and site coordination (industry/institutional setting preferred); or equivalent combination of education and experience.
Proficiency in FDA regulatory requirements preferred.
Overnight travel required, 60 to 80% depending on the clinical project requirements.
MiMedx® is the global premier processor, marketer, and distributor of human amniotic tissue. MiMedx® has distributed over 1,000,000 amniotic tissue grafts worldwide and achieved profound clinical outcomes in multiple therapeutic areas including ophthalmology, spine, chronic wounds, dental, orthopedic surgery, sports medicine, and urology. With this groundbreaking human tissue offering that promotes bioactive healing, MiMedx® believes its unmatched knowledge and superior processing of amniotic tissue strategically positions the Company to become the leader in regenerative medicine.