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Clinical Research Project Manager

2 months ago

Chapel Hill, United States SiteBridge Research, Inc. Full time $80,000
Job DescriptionJob Description

SiteBridge Research, Inc:

Founded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. The SiteBridge Network extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.

Job Description: The Clinical Research Project Manager is an experienced research professional who will provide support and manage projects with, and under the direction of, the Director of Clinical Research Coordinators & Project Managers for multiple ongoing studies within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Clinical Research Project Manager will be responsible for identifying, developing, and gathering the necessary resources to complete clinical research projects and coordinate the project’s start-up, maintenance, and close-out activities. They will be required to work closely with the site staff to ensure the deliverables and timelines are met. In addition, and most importantly, this role represents SiteBridge Research’s mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. This role will report to the Director of Clinical Research Coordinators & Project Managers and the Head of Clinical Operations. This position is remote with up to 40% travel for candidates with the prerequisite experience.

Responsibilities:

  • Work closely under the direction of the Director of Clinical Research Coordinators & Project Managers to coordinate project start-up, maintenance, and close-out activities (including but not limited to study start-up and close out, recruitment, and regulatory submissions)
  • Work collaboratively with the Clinical Operations leads, Project Managers, and site team to ensure project deliverables are completed.
  • As necessary, step in and fill site and study level needs (including but not limited to site set-up and CRC duties to meet SBR and sponsor needs)
  • Ensure ongoing communication to team members of the scope of work, timeline and project goals, technical information, and input from study teams throughout the project, including significant changes in resourcing, scope of work, and timelines
  • Evaluate and communicate metrics of all activity related to assigned projects
  • Consult with SiteBridge Leads to determine the best course of action for projects related to the site and trials
  • Effectively communicate with physicians, sponsors, stakeholders, and study staff as related to assigned projects
  • Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
  • Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced, and objective manner
  • Prepare, participate in, and follow-up on audits/inspections as needed
  • Participate in required training and education programs.
  • Participate in meetings (i.e., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary
  • Other duties and support as assigned related to site and study operations
  • Travel is required (up to 40%) for projects related to site development and operations

Qualifications/Required Experience:

  • Minimum Bachelor's degree; a combination of education and related technical/professional experience may be substituted for the degree requirement and will be considered on a case-by-case basis
  • Minimum of 4 years of clinical research or related experience; experience as CRC, CRA, or related is required
  • Minimum of 2 years of Project Management experience highly preferred
  • Bilingual, Spanish speaking candidates are encouraged to apply
  • Proven success managing and integrating multiple projects across an organization
  • Demonstrated knowledge of clinical trials project management and execution related to but not limited to start-up, regulatory submission, site feasibility, etc.
  • Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
  • Experience with eSource, eRegulatory, and CTMS is required
  • Experience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plus
  • Strong preference for experience within multiple phase research and therapeutic areas
  • Experience with necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc.
  • Excellent communication skills, attention to detail, problem-solving, follow through, and organizational skills, with the ability to multi-task and work under/meet deadlines
  • Detail-oriented and meticulous in all aspects of work
  • Superior interpersonal, organization, and management skills
  • Capable of working independently with minimal supervision
  • Understanding of medical terminology as well as standard clinical procedures and protocols

Additional Qualifications:

  • Strong project and time management skills
  • High level of collaboration; customer-oriented awareness and focus
  • Skilled with standard computer programs including the MS Office suite
  • Strong interpersonal and written and verbal communication skills

Additional Information:

SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills, and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.