The Office of Research Development and Administration (ORDA) at BRF is seeking a Clinical Research and Regulatory Coordinator.
Responsible for the implementation and support of clinical trials under the auspices of the Office of Research Development and Administration (ORDA).
Responsibilities include but not limited to:
Execute and coordinate daily clinical research activities according to the organization’s SOPs study protocols, GCP and FDA/ICH guidelines. Facilitate, coordinate and release research SOPs and guidelines.
Complete and maintain regulatory documents required by various regulatory and sponsor entities.
Serve as the lead contact for study sponsors, governmental agencies, Institutional Review Boards, participating physicians, hospital departments, research staff and patients. Respond to queries in a timely manner.
Promote Physician relations for clinical research collaborations. Communicate regularly with physician practices for patient referrals.
Assist Principal Investigators in planning, development and execution of clinical research trials.
Provide on-site services and protocol-specific training to research staff.
Provide ongoing monitoring of study procedures and schedule study visits according to study protocols.
Communicate with study participants to obtain and maintain informed consent, compliance with study protocol schedules. Provide education to study participants to ensure understanding of proper medication dosage, administration and treatment.
Meet/exceed patient enrollment goals while ensuring quality of collected data. Participate in recruitment and selection of medical study participants by interviewing and reviewing medical history, questionnaires and lab results to determine compliance with eligibility requirements.
Complete case report forms and maintain source documentation per GCP guidelines. Create entries and update research databases (e.g. clinicaltrials.gov).
Maintain inventory level of all supplies and equipment.
Perform regular internal audits of study records to ensure compliance.
Obtain blood samples, vitals, and other testing as needed for clinical research studies.
Assist Business Manager with the review of monthly study-specific financial reports, including study participant billing, to ensure billing compliance. Assist with budget coverage analysis and budget analysis forms according to study protocol procedures.
Attend Investigator meetings and clinical research training conferences.
Other duties as assigned.
Click below to download the PDF for more information, such as minimum qualifications and education requirements.
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