Clinical Research Coordinator

Urology America, MSO•Austin, TX

37d•Onsite

About The Position

Experienced Research Coordinator needed to continue building and lead a newly growing research department. Will have the opportunity to help create a premier research facility. We will provide the necessary support, budget, staff, etc. You would work closely with our PI and Sub-Is on the various studies. Will be working in highly motivated large private practice urology group with 30+ providers.

Requirements

Must have knowledge of and experience with relevant federal and state regulatory guidelines.
Must have > 5yrs experience with conducting clinical trials.
Experience with evaluating and implementing study protocols and budgets.
Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
Effective time management and the ability to prioritize work.
Excellent communication skills and the ability to interact with all levels of management, staff, and physicians.
Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
Understanding of medical terminology.
Ability to use multi-line phone systems and basic computer systems.
Interpersonal communication with internal staff and external customers.
Skill in reading medical chart terminology.
Time Management.
Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
Elicit appropriate information for patients to clinic staff.
Ability to read and understand information and ideas presented in writing.
Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.

Nice To Haves

Urology based clinical experience preferred.
Certification via ACRP or the equivalent preferred.

Responsibilities

Work to build the research department in scope, size, reputation, and professionalism.
Assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, communication with study sponsors.
Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
Obtain and maintain consent of patients with the highest ethical standards.
Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, etc.
Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
Communicate with and support patients and their families as necessary.
Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records.
Must have or gain knowledge of relevant software/programs.
Have a basic and working knowledge of trial design, statistical methods, etc.
Triage, record, and report adverse events. Record and report any protocol deviations.
Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
Create and maintain department SOPs, NDAs, CVs, certifications, etc.
Evaluate, purchase, maintain necessary equipment.
Maintain HIPAA compliant communication and confidentiality, at all times.
Maintain study budgets and monitor invoicing, billing, and payments.
Participate in site visits, SIVs, monitoring, etc.
Complete necessary study close-out steps and documentation.
Assist with other duties assigned.