RN, LPN, CMA/RMA Clinic Research Lead

Deaconess Health System•Evansville, IN

71d

About The Position

Promotes good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording and maintaining data and source documentation. Position open to RN, LPN, or CMA. Completes pre-study activities Reviews and knows requirements of study protocol thoroughly Coordinates study related sponsor/CRO visits for site qualification and site initiation meetings Develops timelines for conducting and completing the clinical trial Coordinates required supplies and resources to efficiently conduct the clinical trial Implements the procedures of the protocol Participates in the screening of patient charts Maintains and, if necessary, develops current patient logs for each clinical trial Obtains volunteer informed consent according to department SOP's. Ensures volunteer's understanding of the informed consent document and his/her participation Completes all study visit procedures as properly trained or licensed Monitors enrollment goals and if necessary adjusts enrollment plan and strategies Accurately records pertinent information in source documentation and ensures transcription is in the case report forms (CRF's) in a timely fashion Provides patient education regarding objectives of the protocol Maintains accurate and current drug dispensation and inventory records for each patient Assesses adverse events and follows up with the Principal Investigator, patient and sponsor as needed. Reports all serious adverse events (SAE's) immediately to investigator and within 24 hours to sponsor. Completes required documentation according to sponsor, regulatory, and company policies Communicates with patient for study-related issues Ensures all appropriate CRF's are completed 48 hours prior to monitoring visits Coordinates, prepares, and attends clinical monitoring visits Serves as the primary contact person for sponsor or CRO Resolves queries from sponsors or CRO within required time lines Efficiently conducts study close-out procedures according to sponsor specifications and company policies, including return of all study product

Requirements

Current certification/license from one of the below:
Certified Medical Assistant- American Association of Medical Assistants
Registered Medical Assistant- American Medical Technologist
Certified Clinical Medical Assistant- National Health career Association
National Certified Medical Assistant- National Center for Competency Testing
Nationally Registered Certified Medical Assistant- National Association for Health Professionals
Registered Medical Assistant- American Allied Health
Certified Medical Assistant Clinical- American Medical Certification Association
Active LPN license in state of employment
Active RN license in state of employment
CPR provider certification required.
Certified Clinical Research Coordinator required

Nice To Haves

At least one year clinical experience preferred.
Phlebotomy skills and preparation of samples for shipping preferred but not required.

Responsibilities

Reviews and knows requirements of study protocol thoroughly
Coordinates study related sponsor/CRO visits for site qualification and site initiation meetings
Develops timelines for conducting and completing the clinical trial
Coordinates required supplies and resources to efficiently conduct the clinical trial
Participates in the screening of patient charts
Maintains and, if necessary, develops current patient logs for each clinical trial
Obtains volunteer informed consent according to department SOP's.
Ensures volunteer's understanding of the informed consent document and his/her participation
Completes all study visit procedures as properly trained or licensed
Monitors enrollment goals and if necessary adjusts enrollment plan and strategies
Accurately records pertinent information in source documentation and ensures transcription is in the case report forms (CRF's) in a timely fashion
Provides patient education regarding objectives of the protocol
Maintains accurate and current drug dispensation and inventory records for each patient
Assesses adverse events and follows up with the Principal Investigator, patient and sponsor as needed.
Reports all serious adverse events (SAE's) immediately to investigator and within 24 hours to sponsor.
Completes required documentation according to sponsor, regulatory, and company policies
Communicates with patient for study-related issues
Ensures all appropriate CRF's are completed 48 hours prior to monitoring visits
Coordinates, prepares, and attends clinical monitoring visits
Serves as the primary contact person for sponsor or CRO
Resolves queries from sponsors or CRO within required time lines
Efficiently conducts study close-out procedures according to sponsor specifications and company policies, including return of all study product

Benefits

Flexible schedules for work-life balance
Paid time off accrues on day one for part and full time employees
Get up to 50% of earned wages with Payactiv - access to the money you worked for, but haven't been paid yet
Earn While You Learn - Deaconess offers tuition reimbursement for many healthcare opportunities, STEP UP program will pay your normal wages for time spent in enrolled class hours for up to 18 hours per week for approved programs. Educational Assistance up to $5.250.00 per calendar year while enrolled in undergraduate or graduate classes.
Tuition.io - Deaconess offers access to a full suite of tools to help manage and educate with student loans and expenses. One on one student loan coaching via email, chat or calls.
Tuition reimbursement
Outstanding Referral Programs
Pet Insurance Available
Medical Premium Assistance of up to 20% is available for eligible full time employees.
Wellness Incentives for full & part-time employee to reduce cost of insurance premium by $33.93 (and $11.30 for spouse, if applicable)
Onsite children's care centers (Infant through Pre-K) at Midtown and Eastside Evansville, Indiana and Henderson, Kentucky. Subject to availability.
Deaconess RN on Call is available for employees 24/7/365 to speak to an RN
Automatic enrollment in a 401K plan at 3% pre-tax contribution with an outstanding employer matching program
Competitive pay, shift and weekend incentives, yearly opportunities for pay increases and bonuses
Career advancement opportunities