Position Requirements: Individual with a license or certification in the medical field. Research experience preferred but not required. Strong organizational and communication skills as well as a professionalism are mandatory. Desire computer proficiency skills: Microsoft Word, Excel, Microsoft Outlook as well as Internet use. Has the ability to travel between offices to complete work/study duties.
Position Summary: Coordinates the development, organization, implementation, and execution of clinical research trials in the indication of Neurology and multi-disciplinary research. Coordinator will assist the Investigator(s) in acquiring and analyzing data. Promotes, restores and maintains patient wellness using balanced clinical judgements and critical thinking skills during the patient’s involvement in clinical research. Coordinator will continually communicate the progression, strengths and problems of study protocols to sponsors, CRO’s, monitors, Director of Clinical Research as well as the Principal Investigator. CRC will act as a liaison between Principal Investigator and Study Sponsor promoting the successful completion of the study while adhering to Good Clinical Practice (GCP) guidelines. Coordinator will continuously assist the Director of Clinical Research in the successful management, implementation and conduction of clinical trials. She/he will assist in the training and education of new coordinators as instructed by the Director of Clinical Research. Promotes and participates as a team member in the daily function of the Research Department and will put forth all efforts to promote a positive/healthy working environment for all within the department.
Specific Duties and Responsibilities:
Organize the implementation of clinical research trials:
Ø Screens all participating clinic office patients as well as the Largo Medical Center’s daily rounding list for the identification and recruitment of potential subjects.
Ø Assists other coordinators in screening, enrollment and patient follow-up visits as directed by the Clinical Director.
Ø Will coordinate trials as a Primary Coordinator and also be assigned a supportive role as back-up coordinator for other CRC’s.
Ø Promotes subject recruitment through various advertising plans (after proper regulatory approvals- Sponsor/IRB), networks with referring providers and community resources to promote and maintain patient enrollment.
Ø Determines effective strategies for retaining participants in clinical trials.
Ø Acts as a liaison with the research community, sponsors, pharmaceutical and device representatives and monitors in recruiting potential new studies to the site.
Ø Directly responsible for research study recruitment, maintaining research study contracted quotas. Communicates with the Clinical Director and Investigators regarding enrollment on a frequent basis.
Ø Identifies and works to solve problems that may arise while a study is being conducted.
Ø Attends professional investigator/coordinator meetings as needed to assure accuracy of protocol implementation and maintain required training. Acts as a Site representative during attendance promoting the site, networking and developing potential business.
Ø Educates and in-services fellow research coordinators and office/clinic staff members on protocol requirements.
Ø Updates physicians, fellow coordinators, and office/clinic staff on protocol changes. Ensures required training is completed and documented.
Ø Corresponds and communicates between IRB, PI, and Sponsor to facilitate implementation of protocol.
Ø Responsible to notify the Clinical Director of patient study related serious adverse events, adverse events with trending, safety issues, non-compliance, deviations, Endpoints and study related charges/billing issues. All reporting will be done with transparency.
Ø Helps to ensure that a research staff member is always available when the doctor is seeing patients to consult with potential referrals.
Executes clinical trial according to study protocol and FDA guidelines:
Ø Recruits patients following protocol guidelines and inclusion/exclusion criteria.
Ø Will travel and manage patients at Satellite sites and/or Partnering offices.
Ø Facilitates communication between the Investigator and patient regarding the nature of the study, risks, benefits and alternative treatments to enhance the patients’ complete understanding of his rights and responsibilities. Informed consent is to be signed by patient prior to any study related procedures.
Ø Discusses protocol procedures with patient and family and educates per medical condition as needed.
Ø Ensures patient, Investigator as well as site compliance to study protocol.
Ø Evaluates patient’s progress while participating in the study via coordinator’s assessment and baseline data, history and physical, medical history, compliance etc.. Educates patients on Investigational Product, dispenses study medication and maintains records of medication compliance, dispensing and product return.
Ø Follows patients during the course of study according to study protocol guidelines as evidenced by i.e. evaluation of lab work, procedures, testing, office visits and phone calls, coordination of external services (home health).
Ø Identifies and reports all applicable adverse and serious events to the sponsor, Investigator as well as the IRB promptly per reporting guidelines.
Ø Records written data in the source binder and enters into case report forms (eCRF) as delineated by the study protocol and governed by the FDA.
Ø Maintains all study source documents and case report forms for the study.
Ø Assists Director of Clinical Research is obtaining signatures from required parties for Regulatory.
Ø Can periodically audits operations to ensure compliance with application regulations.
Develops plan of action to successfully implement clinical trial according to protocol.
Ø Reviews protocol along with Clinical Director for patient safety, cost effectiveness, scientific merit and feasibility.
Ø Assists Regulatory in collecting data to ensure accurate reporting and to the Institutional Review Board for review and approval as needed.
Ø Design/Organize a system for each study in order to accurately maintain records for the study sponsor, IRB and per FDA regulations.
Ø Complete data entry and other time sensitive tasks to the sponsor or clinical coordinating center per protocol/sponsor timelines.
Ø Orders supplies and can schedule equipment maintenance.
Responsible for development of personal and professional growth to ensure the success of clinical trial development.
Ø Reviews medical, professional, research journals, or attends educational meetings to increase and maintain knowledge base as it relates to Neurological disease, General Health and promoting patient wellness.
Ø Demonstrates a consistent understanding of department’s operating procedures. Conducts annual reviews of SOP’s and trains on newly implemented standards of performance. Assists in identifying new areas for quality improvement, development and implementation of policies and procedures.
Ø Assists in interviewing and determining candidates best suited for the department.
Ø Optional: Obtains certification as a clinical research coordinator through ACRP.