Clinical Research Assistant- Medical Assistant

U.S. Urology Partners•Carmel, IN

18h•Hybrid

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. This role involves administratively and clinically coordinating a team to effectively conduct a minimum of six clinical trials (level 1-3 clinical research protocol) and evaluating/analyzing clinical data and trial results. The CRC schedules, plans, and participates in study monitoring visits, addressing any potential queries or deviations in accordance with the study contract. They act as a liaison between the sponsor and the research department. In collaboration with the Clinical Manager, they advise treating physicians of clinical protocol opportunities and procedures. The role includes recruitment of study subjects, using professional experience, discretion, and judgment to include or exclude potential subjects based on trial criteria. The CRC acts as a study resource for patients and families, discusses study protocols with patients, verifies the informed consent process and documentation, and addresses any questions or concerns the research patient may have regarding the study. They provide patients with written communication of their participation, ensure subjects' understanding and willingness to continue participation, and conduct study-specific procedures and assessments (within their scope of practice) at each visit. This includes providing patients with all treatment option information within their scope of practice, such as pamphlets and protocol direction. The CRC dispenses study medications in accordance with protocol requirements within their scope of practice and performs Investigational Product accountability for accurate compliance. They collect, process, and ship blood/urine specimens at scheduled times and supervise the scheduling of research patient visits and procedures consistent with protocol requirements. The CRC performs study-specific procedures, including but not limited to ECGs, vital signs, height, weight, and injections, within their scope of practice. They collect, compile, and maintain source documentation, and complete and maintain case report forms per FDA guidelines, ensuring source completeness and accuracy. The role involves preparing for and participating in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. The CRC is responsible for the reporting of and follow-up on adverse events and serious adverse events per study protocol. They screen 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. The CRC contacts outside healthcare providers and communicates with subjects to obtain follow-up information. They ensure the scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials. They also ensure the filing and maintenance of all regulatory documents and attend sponsor meetings for education and understanding of protocols or protocol addendums. Maintaining required continuing education hours for certifications and adherence and knowledge of OSHA, including the location and use of Material Data Safety Sheets (MSDS), are also key responsibilities. The role requires maintaining a high level of patient confidentiality and performing all other duties as assigned.

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
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.

Nice To Haves

2-3 years related Research experience Preferred.

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.
Dispenses study medications in accordance to protocol requirements with 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 ECGs, 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.