The Baltimore Research and Education Foundation (BREF) is a non-profit corporation that supports the biomedical research and education missions of the Veterans Affairs Maryland Healthcare System (VAMHCS) by administrating and facilitating biomedical research and education endeavors funded by federal and non-federal sponsors. In this capacity, BREF provides research staff and other related services for conducting clinical research at the Cooperative Studies Program Coordinating Center (CSPCC) in Perry Point, Maryland.

GENERAL JOB SUMMARY

The Clinical Research Project Manager oversees and manages the day-to-day operations of multi-site clinical research activities conducted within the Externally Funded Research Program, managed by VA Cooperative Studies Program Coordinating Center at Perry Point, MD in collaboration with BREF. They will be responsible for coordinating interactions and cooperation between the Site Investigators, the CSPCC, the Albuquerque Research Pharmacy, other VA offices regulating research, and the sponsor’s office. This position will primarily provide support for the VA International Coordinating Center (ICC) for Strategies and Treatments for Respiratory and Viral Emergencies (STRIVE) program but will be assigned to other CSPCC projects as funded awards are received.

JOB RESPONSIBILITIES:

Initiate and coordinate each clinical trial at the clinical trial sites by:

· Responsible for assigned aspects of clinical studies to ensure studies are completed on time, within budget, and in compliance with SOPs, applicable regulations and ICH/GCP guidelines, study protocols, study specific manuals and procedures.

· Participate in or lead clinical trial-related systems set-up including implementation and maintenance of appropriate tracking systems, standards, and processes to ensure quality across investigative sites.

· Actively participating in the editing and distribution of required study documents, such as: protocols, informed consent forms, HIPAA forms, privacy and technology security forms, case report forms, operations manuals, and progress reports.

· Responsible for maintaining and reporting accurate and up to date (“audit-ready”) clinical trial documentation within relevant tracking systems required by local and programmatic SOPs and by the regulations and guidelines that govern clinical trials (FDA, ICH, GCP, etc.).

· Participate in or facilitate site engagement and communications with investigators and/or staff to support trial milestones and deliverables. Serving as a resource person regarding details of the study protocol for site investigators and as primary point of contact for issues related to the clinical trial and sites.

· Organize meetings for the successful completion of the studies. Scheduling, preparing agenda, leading meetings, and succinctly documenting (meeting minutes) internal and external meetings. Tracking meeting deliverables and action items for stakeholders. Participating in study-wide conference calls with external partners.

· Reviewing study data for completeness, compliance, and adherence to study objectives. Working with CSPCC staff, investigators, and study staff at the various sites to identify and resolve any queries or protocol non-compliance issues.

· Participate in or lead the set-up and implementation of effective investigator and site monitor training.

· Responsible for reviewing and following up on any action items identified in monitoring visit reports.

· Acting as the lead coordinator for CSPCC staff working groups collaborating with outside vendors to create customized technology tools (e.g., Electronic Data Capture)

· Participating in the peer review of other administrative professionals’ work and conducting routine internal audits of project management quality and regulatory adherence.

· Identifying risks and reporting suspected non-conformances using established center practices.

· Performing related duties, within the scope of role, to support the needs of the CSPCC.

· Occasional overnight travel 1-2 times a year for trial meetings is required.

ESSENTIAL SKILLS:

· Knowledge of the processes involved in formulating a research study, from the planning phase through the ongoing phase, to the closeout phase.

· Knowledge of Project Management/Clinical Research Administration skills.

· Ability to proactively identify potential issues/risks and recommends/implements solutions.

· Ability to effectively develop and manage various project stakeholders.

· Excellent organizational, oral and written communications skills.

· Excellent interpersonal/teamwork aptitude and attention to detail.

· Skill with Word, Excel, Outlook, Access, SharePoint.

· Knowledge of Good Clinical Practices (GCP).

· Skill in recognizing data base problems and making recommendations to resolve problems.

· Medical terminology experience useful.

QUALIFICATIONS: Five-Ten years of experience in research protection, federal and regulatory issues, research ethics, regulatory compliance, use of centralized IRBs and master agreements, and project management. Certification in a Clinical Research program from an accredited university or professional organization and/or previous experience in clinical research will be an advantage to consideration of the candidate. Bachelors’ degree is required and a degree in a clinical sciences or health-related field is preferred.

Salary is commensurate with education and experience. Job location is at VA Medical Center, Perry Point, MD or Fallon Building, Baltimore, MD. The position is eligible for telework on occasion or regularly scheduled with supervisor approval. This position is not 100% remote. Benefits include health, life and long-term disability insurance, 403(b) retirement program and annual, sick and holiday leave.

EQUAL OPPORTUNITY EMPLOYER

BREF is an equal opportunity employer, thereby ensuring equal opportunity for employment and advancement to all qualified persons without regard to race, color, religion, national origin, sexual orientation, lawful political affiliation, marital status, non-disqualifying physical or mental handicap or age.

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Commute:

• Perry Point, MD (Required)

Ability to Relocate:

• Perry Point, MD: Relocate before starting work (Preferred)

Work Location: In person