Research Coordinator

Job Title: Research Coordinator

Location: Indianapolis, IN (86th & Naab)

Schedule: M-F 8-5

Type: Direct Hire

Job Overview:

LHH Recruitment Solutions has partnered with a healthcare organization seeking a Research Coordinator. This position is based in Indianapolis, IN and requires 100% on-site presence until fully trained (6-18 months) The Research Coordinator is responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols. This is a Direct Hire position.

Responsibilities:

• Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
• Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and the practice.
• Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
• Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
• Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Participate in internal quality assurance; review monitor reports for trends across studies.

Qualifications:

• Minimum associate degree in related field
• CCRP- not required.
• Experience with both the data and patient coordinating side of clinical trials is required
• Prior clinical trial experience is required- preferably within pharmaceuticals

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our program provides employees with the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.