What are the responsibilities and job description for the Director of Clinical Research position at Rivus Wellness and Research Institute?
Rivus Wellness and Research Institute is growing and we are looking for individuals who are passionate about delivering exceptional patient care. In this position, you will be responsible for the overall success of the clinical research operations by managing a team of 5 individuals and providing oversite to 20 studies. Previous management experience with a track record of success is required. In general, the ideal candidate for this position will demonstrate exceptional team building skills and possess robust knowledge of Clinical Research including study conduct, regulatory compliance, HIPAA, ALCOA C, SOP creation and adherence, recruitment, contract negations, initiation of training programs, employee retention, departmental budgeting, and professionalism. Pervious experience with Central Nervous trials is preferred, but not required.
Essential Duties
Essential Duties
- Develop a team of individuals capable of conducting the site's extensive research portfolio.
- Collaborate with executive team regarding efficiencies and deficiencies of daily work flow. Implement changes accordingly.
- Develops and Implements new research processes - streamlines current research processes.
- Ensures that sponsor has been invoiced for all completed visits.
- Work with the Director of Patient Experience to develop relationships with community physicians and other potential referral sources.
- Seek new study opportunities.
- Ensure site is appropriately staffed for patient load.
- Payroll
- Time off requests
- Department budgets
- Community outreach
- Attend Investigator Meetings with Principal Investigator- asks questions and collects pertinent study information while at investigator meeting. Completes required protocol, EDC and any additional training while at meetings.
- Attend Site initiation visits from various drug sponsors and conduct site initiation tours.
- Schedule and attend PSV’s
- Negotiate contracts between site and sponsor.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Quality Assurance
- Provide QC to Senior CRC when CRC is unavailable or unable.
- Ensures all documents are signed/documented by Pl.
- Ensures all source documents are complete by rater and/or coordinator and consistent with data in the EDC before patient charts are put away.
- Ensures all data both in source documentation and EDC is accurate according to protocol.
- After data is verified acknowledge in Realtime/CTMS.
- Conduct random QC audits for a selection of each CRC’s visits on a monthly basis.
- Prepare for AND participate in quality assurance audits conducted by study sponsors and federal agencies.
- Develops and implements new front office processes - streamlines current front office processes.
- Implement and update research and office policies and procedures.
- Educates staff on job duties.
- Oversee that research staff is following policy and procedures and adhering to their job duties.
- Submit initial regulatory packet and paperwork when awarded a new study within a timely manner.
- Assign awarded studies to appropriate study coordinator.
- Manages and updates Standard Operating Procedures.
- Meet with monitor during onsite visits.
- Attend all study training, updates, and IMV’s, both in-person and virtual.
Requirements
- Previous clinical research management experience (1 years)
- Bachelor's Degree or equivalent experience
- Ability to multitask
- Ability to follow site SOP and sponsor protocols without deviation
- Strong verbal and written communication skills
- Ability to work on multiple computer platforms for patient record keeping
- Ability to meet and exceed goals
- Ability to travel if/when in person investigator meetings resume
Additional Info
- Monday-Friday 8am-5pm
- Full BENEFITS after 90 days!!
- FULL TIME. 40 Hrs/week
- 2 weeks PTO
Salary : $60,000 - $80,000
Clinical Research Associate 1
Allen Spolden -
Oklahoma, OK
