$80K — $100K *
In collaboration with Principal Investigator(s), Hospital Personnel, and the Manager of the Office of Clinical Research (Research Manager), the Research Project Manager’s (RPM) primary duty is in the performance of Office of Research work directly related to management and general business operations. The RPM will exercise discretion and independent judgment with respect to matters of significance by acting as the responsible party for start-up and day-to-day operations of all assigned ongoing clinical trials ensuring adherence to Good Clinical Practices (GCP) and Standard Operating Procedures (SOP). The position is responsible for the smooth operation of all research projects from a managerial and administrative standpoint. The RPM implements clinical trial activities for research protocols where primary responsibilities include: Monitoring, maintaining, and submitting regulatory documents and files in compliance with all legal requirements, managing administrative matters and analyzing reports related to research data and databases, assisting Principal Investigators in recruiting patients, and ensuring that informed consents have been obtained. The RPM creates, submits and tracks financial invoices submitted to Sponsors in accordance with contractual and regulatory requirements. This position is responsible for mentorship of coordinators, students and volunteers.
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:
A. JUDGEMENT/DECISION MAKING
1. Exercises a high degree of independence in decision-making within the scope of defined job description.
2. Demonstrates discretion and sound judgment in performing complex tasks related to clinical trial management.
3. Seeks guidance as necessary for performance of duties.
4. Identifies situations, challenges, opportunities, problems, or issues; makes assessments from a variety of perspectives, and considers various possibilities and alternatives; chooses appropriate course of action for given situation.
5. Prioritizes work to meet department/hospital needs, standards, and deadlines.
6. Ensures the safety of research subjects. Conducts clinical research in accordance with GCP guidelines.
7. Identifies and appropriately to needs of patients and external parties.
8. Communicates pertinent information to appropriate persons in a timely manner.
9. Coordinates, facilitates, and arranges the scheduling of internal and external appointments and meetings.
10. Adheres to department/hospital policies and procedures.
B. JOB KNOWLEDGE/SKILLS CRITERIA/STANDARDS:
1. Excellent organizational skills.
2. Expert knowledge of HIPAA and human subject research regulations (both OHRP and FDA).
3. Expert knowledge of clinical research processes.
4. Ability to work with a high degree of independence as well as function effectively as a member of a team.
5. Displays initiative in conducting clinical research studies.
6. Ability to prioritize work, handle multiple competing priorities, and meet .
7. Flexible as needed to accommodate study and needs of the department.
8. Demonstrates strong critical thinking and problem solving abilities.
9. Excellent customer service, organizational and time management skills.
10. Excellent written and oral communication skills.
11. Demonstrates intermediate level proficiency in computer applications related to the conduct of clinical trials (Microsoft applications, Adobe Acrobat, EPIC, Insight).
12. Maintains confidentiality of patient research data.
Valid through: 7/13/2021