In collaboration with Principal Investigator(s), the Research Project Manager is responsible for the organization and day-to-day operations of all assigned ongoing research projects. The RPM will assist the PI(s) with all essential research functions, from IRB submission to data collection and analysis to manuscript preparation and submission.

Screening patients for participation in the research protocol, data collection, 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 Institute of Technology (MIT) in collaboration with the Center for Gynepathology Research (CGR) and will be required to attend weekly lab meetings at MIT.

The RPM will also play significant role in marketing and outreach for the Endometriosis & Adenomyosis Care Collaborative.

Duties include updating Facebook, Instagram, and/or X pages, assisting in organization of outreach 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.

Qualifications

QUALIFICATIONS:

• 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.

• Competence with research related computer software preferred and/or willingness to learn new 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.

CRITERIA/STANDARDS:

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 responds 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.

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 deadlines.

7. Flexible schedule 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.

EEO Statement

MGB is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination.