The Clinical Research Associate will be responsible for facilitating research studies; providing knowledgeable information regarding each research protocol to the medical and nursing staff; evaluating the eligibility of potential candidates for research studies; assisting in the informed consent process; monitoring research study compliance; collecting and submitting data; coordinating required study procedures to meet protocol requirements and maintaining a system for effective data flow. Will travel between the Flint and Macomb locations.
Essential Functions and Responsibilities:
Evaluates eligibility of candidates for clinical research studies by reviewing eligibility requirements and/or collecting pertinent data on potential candidates, verifying appropriateness of patients for entry to clinical trials, and assisting the other staff in determining eligibility of potential patients.
Assists the investigator with the informed consent process and assures that the research team and the patient have adequate information to achieve the informed consent process.
Registers and randomizes eligible patients.
Submits accurately completed protocol data forms to the sponsoring group in a timely manner as dictated by the specific protocol.
Coordinates compliance of procedures required by the protocols through accurate communication with the site / principal investigator (physician), patient, nurses, and office/hospital staff.
Maintains contact with regulatory specialist to ensure data submission is accurate and timely. Upon request submits regulatory documents to regulatory specialist to include in the IRB submission of protocols and other information to the IRB.
Assists the investigators and clinicians in identifying and enrolling eligible patients into clinical trials/ studies and assures compliance to protocol requirements.
Educates patients and their families regarding research protocols, and keeps them informed of procedures and changes in the studies in which they are participating.
BA/BS degree in biology, psychology, nursing or other clinical research-related area or equivalent education and experience required
Two yrs experience with research related activities with clinical practice, ICH guidelines, FDA and OHRP regulations, IND and SAE reporting, and protection of human research participant standards, regulations, and laws.
Masters in Research/ Nursing or related field
Clinical Research Certification CCRC/CCRP
Nicotine Testing - To provide a safe, healthy environment for our patients, employees and visitors, as of February 1, 2013 McLaren no longer hires individuals who use nicotine and will conduct nicotine testing during the pre-employment process. If the test is positive the offer will be rescinded. Individuals who test positive may re-apply for employment after six months.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
Primary Location Michigan-Flint Location-McLaren Reg Med Center
Work Locations McLaren Reg Med Center 401 S Ballenger Hwy Flint 48532
Job Non-Health Professional
Organization McLaren Health Care Corp
Employee Status Non-Management
Job Type Part-time
Job Level Day Job
Job Posting Apr 24, 2019, 9:31:45 AM
On Call No