Senior Research Coordinator/Project Manager, 40Hrs, Cardiovascular Medicine
Brigham & Women's Hospital(BWH)

The Sr. Clinical Research Coordinator/Project Manager (CRC/PM) is responsible for assigned day-to-day coordination and overall management of sponsor activities for assigned clinical trials in the BWH/DFCI Amyloid Program; PI-initiated trials and industry sponsored. Sponsor activities include coordinating trial startup and site startup activities, providing training to participating site research staff, IRB regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with FDA, regulatory authorities and manufacturers, etc. The CRC/PM will be responsible to report on his or her defined deliverables, to identify variances in project plan and to develop contingency plans when necessary to keep project milestones on track. The CRC/PM will report to the Principal Investigator to implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted at BWH. The CRC/PM will be responsible for budget oversight and participates in research subjects' reimbursements and sponsor invoices. Has direct management responsibility of research coordinators and research assistants. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration. This individual is responsible for creating a proactive, knowledgeable and cohesive project management platform that will support the research community.

1. Responsible for day-to-day oversight and management of assigned projects.

2. Responsible for development and maintenance of Trial Master File (TMF),

3. Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.

4. Initiates, plans, facilitates and oversees the research project start-up, active and close out phases; for PI Initiated / Industry Sponsored trials.

5. Responsible for improving Case Report Form design with PI and study coordinators. Maintain study-related databases and prepare protocol-related reports as needed.

6. Responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.

Regulatory & Compliance

7. Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.

8. Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.

9. Responsible for managing paper and electronic regulatory binders. Will maintain per BWH CTO standards.

Data Management & Clinical Trial Monitoring

10. Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.

11. Regularly reports data compliance status to key stakeholders; i.e. BWH PI, study Sponsor, BWH CTO. Implements corrective action to maintain data compliance when necessary.

12. Submits required "progress / tracking" reports to key stakeholders, when applicable.

Staff Hiring, Supervision, Training & Development

• Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.

• Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting. Will develop and agenda, take attendance and document all applicable meetings.

• Will communicate all personnel concerns to the PI for the appropriate response and follow up.

Qualifications

• Bachelor's degree required.
• Experience working on clinical trials is required, with a minimum of 4 years of clinical and regulatory related experience preferred.
• Experience working with patients directly.
• Must have the ability to function independently.
• Must be able to perform day to day responsibilities independently with minimal supervision PI. Must be proficient in the following; identifying complex regulatory scenarios that require consultation, clinical trials start-up, active and close out phases, clinical research local policy and federal regulation. Must have some proficiency to manage personnel issues and to provide critical feedback to supervisees, when applicable.
• Knowledge of clinical trial process. In addition, has experience in protocol development, data compilation and analysis. The Manager will be skilled at developing tracking systems to ensure timely data management by the clinical research staff. They will also have expert knowledge of Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required. Must have computer skills including the use of Microsoft Office and working knowledge of EPIC and Oncore applications.

Skills, Abilities, Competencies:

• Team player with ability to interact well with both colleagues and patients

• Detail-oriented

• Strong organizational and communication skills.

• Demonstrated analytical skills.

• Effective problem-solving skills.

• Ability to supervise and train staff effectively.

• Strong database management and computer skills.

• Must possess aptitude for budget management.

EEO Statement
Brigham and Women's Hospital is an Equal OpportunityEmployer. All qualified applicants will receive consideration foremployment without regard to race, color, religion, creed, sex, sexualorientation, gender identity, national origin, ancestry, age, veteran status,disability unrelated to job requirements, genetic information, militaryservice, or other protected status.

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