Research Coordinator Medicine Critical Care Full Time Days

Description

DMC Detroit Receiving Hospital, Michigan’s first Level I Trauma Center, helped pioneer the evolution of emergency medicine and currently has one of the busiest and most well-equipped emergency departments anywhere. The first and largest verified burn center in the state is at Receiving, and it is one of only 43 in the nation. Receiving also offers the state’s leading 24/7 hyperbaric oxygen program, Metro Detroit’s first certified primary stroke center, and the nationally recognized and accredited DMC Rosa Parks Geriatric Center of Excellence.

Summary Description:

Under the limited direction of the Principal Investigators of clinical trials investigations, has the primary responsibility of planning and coordinating regulatory and operational activities of drug and device trials.

Acts as liaison between research department and collaborating hospitals and sponsors for research purposes and to coordinate trial initiations, monitor activities, provide protocol training, and so forth. Coordinates .and designs processes to ensure compliance to protocol and quality data acquisition, including but not limited to procedures for subject recruitment and retention, scheduling visits, conducting follow-up contacts with patients, pre-procedure testing, patient consenting, medication review, drug accountability, randomization, patient education, and so forth. Acts as liaison for all study patients between the facility and physician.

Oversees compliance with regulatory issues and documentation related to investigational device exemption (IDE) and investigational new drug (IND) clinical trials conducted by the department, as well as humanitarian-use devices utilized in the research process.

Provides support to physicians and fellows in study protocol development, regulatory documentation, and protocol procedures. Oversees study procedures and maintains study documentation in accordance with established Good Clinical Practice (GCP) guidelines, Code of Federal Regulations (CFR) Title 21-regulations, and applicable statute(s). Prepares and submits necessary documentation to Institutional Review Board (IRB) for approval prior to initiation of study, as well as ongoing reporting. Oversees completion of case report forms and query resolutions for sponsoring agencies in order to facilitate prompt and full payment of agreements and to ensure the goals of time, cost, and quality are met. In collaboration with study investigator(s) and in a manner consistent with the Declaration of Helsinki and Health Insurance Portability and Accountability Act (HIPAA), assures the protection of the patient’s rights and safety. Reports adverse events according to IRB, Sponsor, and FDA guidelines.

Facilitates external monitoring and auditing of research activities.

Interviews, schedules, orients, trains and evaluates appropriate nursing units, research nurses and ancillary staff. Conveys information and provides in-services to departments impacted by study requirements. Reviews clinical site agreements (contracts) and acts as liaison between involved parties. Corresponds with Medicare intermediaries to obtain approval for reimbursement of care provided in correlation with clinical trials. Works with patient financial services to obtain pre-certification for research-related procedures from insurance companies. Ensure that charges for study-related care and subject stipends are properly documented and charged to study guarantor accounts. Assists in data collection, quality control review, analysis of results, and preparation for presentation or submission for publication. Responsible for maintaining awareness of new regulatory issues and identifies new research activities. Develops and edits Standard Operating Procedures. Provides support to supplementary projects that advance the goals of the department and the institution’s mission, vision, and values.

Minimum Qualifications:

1. Master Degree and/or higher educational progression in Business Administration, Science, Research, or Nursing.
2. Two years of progressively more responsible clinical or medical research required.

Skills Required:

1. Interpersonal and communication skills to interact independently and effectively with all levels of personnel and external customers, while maintaining confidentiality.
2. Knowledge of Microsoft Office applications
3. Ability to operate computer and access clinical information