Clinical Research Assistant- Medical Assistant

Urology of Indiana LLC•Carmel, IN

2d•Onsite

About The Position

The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations.

Requirements

Associates or Bachelor’s Degree from an accredited college or university.
Good Clinical Practice (GCP) Certificate
International Air Transport Association (IATA) Certificate
CCRC certification through an accredited organization (ACRP/SoCRA) is required
2-3 years related Research experience
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Thorough knowledge in computer information systems.

Responsibilities

Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results.
Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract.
Acts as a liaison between sponsor and the research department.
In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures.
Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria.
Acts as a study resource for patients and family.
Discusses study protocols with patients and verifies the informed consent process and documentation.
Addresses any questions or concerns the research patient may have regarding the study.
Provides patient with written communication of their participation.
Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit.
Provides patients all treatment option information within their scope of practice such as pamphlets and protocol direction.
Dispenses study medications in accordance to protocol requirements within his/her scope of practice.
Performs Investigational Product accountability for accurate compliance.
Collects, processes and ships blood/urine specimens at scheduled times.
Supervisors scheduling of research patient visits and procedures consistent with protocol requirements.
Performs study specific procedures, including but not limited to ECG’s, vital signs, height, weight, injections etc. within his/her scope of practice.
Collect, compile and maintain source documentation.
Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy.
Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups.
Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol.
Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance.
Contacts outside health care providers and communicates with subjects to obtain follow up information.
Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
Ensures filing and maintenance of all regulatory documents.
Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums.
Maintains required continuing education hours required for certifications.
Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS).
Maintains a high level of patient confidentiality.
Performs all other duties as assigned.