- Applies knowledge of study design to evaluate the protocol.
- Submits documents to the Scientific Research Committee to evaluate feasibility, assists with the developmental plan for resource allocation including budgetary considerations, contract negotiations, personnel needs and physical requirements of protocol.
- Evaluates staffing needs based on current research activity and newly accepted protocols.
- Implements staff assignments to accommodate new research clinical protocols.
- Monitor enrollment goals and modify recruitment strategies as needed.
- Analyzes research team's performance in relation to study data time lines, query necessary.
- Initiates and/or assists with appropriate problem solving strategies regarding personnel and department concerns.
- Assures all staff participating in trial are in-serviced thoroughly on protocol, compliance, Good Clinical Practice, documentation, and provide in-service for inter-departmental personnel who will be participating in the clinical trial.
- Knowledge and demonstrated competency on all computer software specific to department.
- Assists in designing system for organizing, planning, and controlling workflow as related to site-specific activities. -Implements reporting structures for efficient billing purposes.
- Acts as a liaison between the pharmaceutical and/or contract management organization and the site.
- Maintains communication with the SRC (Scientific Review Committee) and IRB (Institutional Review Board): annual updates, adverse events, safety reports, protocol amendment, consent modifications.
- Tracks internal events to recognize trends and inform the PI so that appropriate action may be taken.
- Collaborates with the health care team to educate, coordinate and facilitate protocol requirements during the in-house and outpatient clinical trials.
- Develops assessment tools to use in clinical research area.
- Coordinates the activities needed to implement changes in a study participants care and/or specific health care need.
- Plans long-term study patient care in relation to identified and potential problems.
- Plans individualized teaching for specific patient or groups of patients concerning treatments and/or procedures based on patient learning needs and readiness to learn.
- Coordinates care that involves other health care members to provide continuity and facilitate the patients' ability to adhere effectively with the protocol requirements.
- Ensures specific protocol related tasks are performed accurately.
- Evaluates the effectiveness of nursing care he/she planned, administered, or delegated and change activities needed to implement change.
- Adheres to age-specific competencies: plans and directs individual teaching plans with regards to age-specific needs.
- Ensures policies and procedures (i.e.: infection control and safety) as mandated by St. Francis Hospital.
- Demonstrates leadership for assuming responsibility for research protocol.
- Performance appraisals and competency assessment on all research staff within the unit annually.
- Participates in coordination of continuing education and in-service programs.
- Responsible for and assists with the development of departmental orientation and in-service program for new research staff.
- Encourages and provides opportunities for professional growth for research staff and nursing personnel.
- Acts as a resource person for the health care team in relation to fulfilling the protocol requirements.
- Fulfills and meets the necessary regulatory requirements, including but not limited to, DOH, JCAHO, OSHA, and the FDA.
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Research Manager - Roslyn, United States - Catholic Health
Description
Research Manager
By growing in every aspect of patient experience and quality, Catholic Health is becoming the most preferred choice on Long Island. From the bedside to the exam room to training and safety and every human moment in between — we're dedicated to providing better care for our communities. Every patient. Every moment. That's what it means to be dedicated to better.
A member of Catholic Health, St. Francis Hospital & Heart Center is New York State's only specialty designated cardiac center. A member of Catholic Health Services of Long Island, St. Francis is consistently recognized by U.S. News & World Report as a national leader for Cardiology & Heart Surgery, as well as for Gastroenterology & GI Surgery.
Duties/Responsibilities:
Clinical Trial Assessment Planning:
Initiation through Completion:
Patient Care:
Staff Management:
REQUIREMENTS: BA, BS, APP/MD or RN. Research experience required BLS. Adept at Office : word, excel , power point.
Salary Range
USD $ USD $88.23 /Hr.
The salary range or rate listed does not include any differential pay or other forms of compensation that may be applicable to this job and it does not include the value of benefits.
At Catholic Health, we believe in a people-first approach. In addition to the estimated base pay provided, employees are eligible for generous benefits packages, generous tuition assistance, a defined benefit pension plan, and a culture that supports professional and educational growth.
Join our team at St. Francis Hospital and discover why Catholic Health was named Long Island's Top Workplace.
