Research Project Manager
Research Project Manager
Newton-Wellesley Hospital
Newton, MA
See who Newton-Wellesley Hospital has hired for this role
Screeningpatientsforparticipationintheresearchprotocol,datacollection,data analysis, database management, literature searches, preparation of papers, abstracts, and presentations for data dissemination, and maintaining regulatory documents and files.
The RPM will work closely with biological scientists at Massachusetts InstituteofTechnology(MIT)incollaborationwiththeCenterforGynepathologyResearch(CGR)andwillberequiredto attend weekly lab meetings at MIT.
The RPM will also play significant role in marketing and outreach for the Endometriosis & Adenomyosis Care Collaborative .
DutiesincludeupdatingFacebook,Instagram,and/orXpages,assistinginorganizationofoutreach events to the community, and actively promoting the multidisciplinary clinic.
Principal Duties And Essential Functions
- Provides administrative and managerial oversight for day-to-day operations throughout the life of assigned clinical trials.
- Works directly with the Doctors, and MIT Scientists to successfully execute research projects’ specific aims and objectives and to ensure adherence to Good Clinical Practices and Standard Operating Procedures.
- Prepares and submits protocol application packets, amendments, continuing reviews, protocol deviations, and unanticipated events to the IRB and Sponsors.
- Maintains, monitors, and submits regulatory documents required by the IRB and Sponsors.
- Creates, when necessary, source documents for studies, completes and submits case report forms, responds to queries, reports adverse events/serious adverse events, and files and archives study records.
- Links research activities related to study protocols to patients in EPIC in conformance with billing grids.
- Conducts research billing reviews after patients’ visits to make sure that labs and procedures are billed to the correct party in accordance with legal and regulatory requirements.
- Creates, submits, and tracks financial invoices submitted to Sponsors and tracks participant stipends and compensation in accordance with contractual and regulatory requirements.
- Creates databases to manage and monitor data collection and data analysis.
- Coordinates study initiation, monitoring, and close-out visits with Sponsors.
- Assists Principal Investigators with cohort identification, management, and follow-up of patients in clinical trials.
- Schedules necessary tests and procedures in accordance with protocol requirements as well as provides patient education.
- Collects, processes, appropriately packages, and ships specimens in accordance with safety regulations.
- Mentors’ coordinators, students, and volunteers.
- Performs other duties as required.
- BS in health care or scientific related field, MS preferred.
- A minimum of five years’ experience in clinical research.
- Ability to perform work in accordance with applicable regulations governing the conduct of clinical trials and human subject research.
- PC proficiency required.
- Competencewithresearchrelatedcomputersoftwarepreferredand/orwillingnesstolearnnew software
- Ability to communicate effectively verbally and in writing.
- Ability to work independently, effectively evaluate and respond to critical situations, and use sound judgment in making decisions.
- Familiarity with medical terminology and medical records helpful.
- Research administration experience preferred.
- Certification as a clinical research associate or coordinator preferred.
- Exercises a high degree of independence in decision-making within the scope of defined job description.
- Demonstrates discretion and sound judgment in performing complex tasks related to clinical trial management.
- Seeks guidance as necessary for performance of duties.
- 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.
- Prioritizes work to meet department/hospital needs, standards, and deadlines.
- Ensures the safety of research subjects. Conducts clinical research in accordance with GCP guidelines.
- Identifies and responds appropriately to needs of patients and external parties.
- Communicates pertinent information to appropriate persons in a timely manner.
- Coordinates, facilitates, and arranges the scheduling of internal and external appointments and meetings.
- Adheres to department/hospital policies and procedures.
- Excellent organizational skills.
- Expert knowledge of HIPAA and human subject research regulations (both OHRP and FDA).
- Expert knowledge of clinical research processes.
- Ability to work with a high degree of independence as well as function effectively as a member of a team.
- Displays initiative in conducting clinical research studies.
- Ability to prioritize work, handle multiple competing priorities, and meet deadlines.
- Flexible schedule as needed to accommodate study and needs of the department.
- Demonstrates strong critical thinking and problem-solving abilities.
- Excellent customer service, organizational and time management skills.
- Excellent written and oral communication skills.
- Demonstrates intermediate level proficiency in computer applications related to the conduct of clinical trials (Microsoft applications, Adobe Acrobat, EPIC, Insight).
- Maintains confidentiality of patient research data.
MA-Newton-NWH Main Campus
Work Locations
NWH Main Campus
Job
Research - Other
Organization
Newton-Wellesley Hospital(NWH)
Schedule
Full-time
Standard Hours
40
Shift
Day Job
Posted Shift Description
Hybrid
Employee Status
Temporary
Recruiting Department
NWH Office of Research
Job Posting
Sep 5, 2024
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Project Management and Information Technology -
Industries
Hospitals and Health Care
Referrals increase your chances of interviewing at Newton-Wellesley Hospital by 2x
See who you knowGet notified about new Research Project Manager jobs in Newton, MA.
Sign in to create job alertSimilar jobs
People also viewed
-
Project Manager
Project Manager
-
Program Manager
Program Manager
-
Senior Program Manager, Program Management
Senior Program Manager, Program Management
-
Assistant Project Manager
Assistant Project Manager
-
Project Coordinator
Project Coordinator
-
Project Manager
Project Manager
-
Project Coordinator
Project Coordinator
-
Project Manager
Project Manager
-
Project Manager
Project Manager
-
Asistant Project Manager
Asistant Project Manager
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More