Clinical Research Coordinator II - Medicine Clinical Trials Office

Mount Sinai Health System•New York, NY

About The Position

Under minimal supervision, coordinates the clinical assessments of the study subjects; analyzes and assists in interpreting moderately complex clinical research data. Prepares grant applications and documents and assists in protocol submissions (for e.g., Institutional Review Board, Grants and Contracts Office). A Clinical Research Coordinator (CRC) II position is currently available within the Medicine Clinical Trials Office. Responsibilities will include activities such as data collection and management of patient clinical information, timely collection of protocol related samples including shipment to outside entities as required, obtain informed consent, collect, maintain and organize study information, and assist with other day-to-day operations as required. Under minimal supervision, the Clinical Research Coordinator II will manage a workload that includes studies of increased complexity.

Requirements

Bachelors degree in sciences or related field.
2 years of clinical research

Nice To Haves

Working knowledge Good Clinical Practice guidelines and Federal research regulations.
Strong understanding and knowledge base of coordination requirements associated with industry funded clinical trials and working
Demonstrated strong organizational and communication skills.
Must be comfortable communicating clinical information to medical personnel.
Proven organizational skills including attention to detail and multi-tasking skills
Ability to work within a team environment as well as independently
Ability to identify, analyze and solve problems while working under pressure
Strong computer literacy required.

Responsibilities

Coordinates activities of ongoing clinical trials: Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, administering lifestyle questionnaires.
Obtain informed consent under supervision of the study investigator(s)
Educate potential participants regarding study requirements.
Screen patients for eligibility though through medical record review
Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
Act as liaison between investigator(s) and study sponsor.
Coordinate activities pertinent to the safeguarding of patients’ rights in research.
Manage study data of ongoing clinical trials under supervision of the Principle Investigator(s): Ensure accurate and complete compilation of subject data through chart reviews.
Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
Maintain source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
Oversee subject recruitment and study enrollment goals. Determine effective strategies for recruiting research participants and retaining participants in long-term clinical trials.
Assist with analyzing data as needed.
Ensure proper compliance with institutional and regulatory requirements: Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations
Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
Regularly inspect study document to ensure ongoing regulatory compliance. The coordinator will also comply with necessary regulatory responsibilities.
Performs other job related duties as required, which may include but not limited to: Participate in Investigators’ Meeting and assist with coordinating Study Initiation Visits.
Attend divisional/departmental/institutional educational and training seminars.
Facilitate sponsor monitoring visits.
Educate new staff regarding overview of clinical research, office policy and procedures, data submission, workflows and specimen handling.
Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meeting.