Collaborated with clinical research team to develop and implement quality assurance and control management policies and procedures. Participated in the development of a new QI program.
Served as a liaison between study sponsors and the sponsor to ensure proper communication with sponsors, CROs, and vendors to ensure timely and accurate documentation of study progress.
Developed and implemented a new study protocol for the trial. Ensured compliance with regulatory requirements, including audit preparation, data entry, and communication.
Selected to lead the project team in the development of a new tool for communication and problem solving. Responsible for the management of the clinical trial.
Provided leadership and communication to the sponsor. Ensured that the trial was conducted in accordance with the protocol, SOPs, and the U.
Provided leadership and strategic planning for project team. Managed the study of the trial. Assisted with the development and execution of the procurement and communication process.
Senior Clinical Research Coordinator
Southwood Psychiatric Hospital
Duties include: recruitment, screening, consenting, assessment, scheduling, study initiation, monitoring, and supervision of study operations, patient enrollment, and follow-up visits.
Conducted study initiation, interim monitoring, and closeout visits. Assisted in the design and implementation of clinical trials, including but not limited to, informed consent, case report form design, data entry, telephone screening
Management of the clinical trial Master file (TMF), responsible for the coordination of study activities, including but not limited to, site initiation, monitoring, and close out visits.
Training and coordination of clinical research Coordinator, including: consenting, informed consent, screening, and enrollment. Study subjects for all aspects of Phase I-IV.
Responsibilities include: Protocol adherence, study initiation, monitoring visits, and CRF review, source document verification, drug accountability, vitals, and venipuncture.
Training of study staff, including but not limited to, protocol amendments, informed consent, case report forms, informed consent forms, case report forms, clinical trial materials, and study specific procedures.