Job description

Lead Clinical Research Associate (CRA)

Rockville, Maryland, United States

LEAD CLINICAL RESEARCH ASSOCIATE (CRA)

Rockville, MD or Conshohocken, PA 

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

Responsibilities:

  • Provide direction and leadership to clinical operations study team.
  • Provide day to day operational management of internal and/or contract CRAs.
  • Coordinate & manage clinical monitoring activities from site start up to site closeout including:
    • Provides overall tactical support for the study.
    • Guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability.
    • Proactively identifies and resolves study-related issues.
    • Oversee the assignment of appropriate project specific training for CRAs.
    • Develop and/or provide input in the development of clinical trial related documents including but not limited to: protocols, study tools, monitoring tools, presentations, meeting materials, case report forms, informed consents, timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, and training materials.
    • Review of clinical monitoring reports to ensure timely completion and identification of issues.
  • Perform qualification, initiation, interim and close out visits and provide visit reports as per monitoring guidelines, as needed.
  • Co-monitor study sites with assigned CRAs as required.
  • Make initial site contact and maintain effective and meaningful communication between study site and clinical team to ensure the success of the clinical trial.
  • Assist in supporting IRB/EC and regulatory submissions.
  • Support and/or interface with external vendors and clinical site personnel, as needed.
  • Supervise shipment of study drugs and materials to the site as required.

Other Duties

  • Ensure implementation and adherence to SOPs and study specific processes.
  • In concert with department leadership, assist in identifying training and development needs and opportunities for CRAs.
  • Assist in the mentoring and training of departmental staff and contribute to the development of junior clinical team members.
  • Assist in ensuring inspection readiness, by ensuring the TMF is up to date at all times, and may be a part of the QC process for reviewing the TMF at regular intervals.
  • Assist in preparation for audits and inspections; participate in inspections and in responding to any issues identified within the timeframe specified.

Experience & Knowledge:

Essential

  • At least 8 years of relevant clinical experience in a biotechnology, pharmaceutical, or CRO company including, and extensive on-site monitoring experience including at least 5 years’ field monitoring experience (performing on-site monitoring of clinical trials, conducting SIVs, IMVs, and COVs for IND regulated clinical research studies).
  • Worked to ensure good documentation practices, and processes to assess, qualify, initiate, monitor and close investigational sites.
  • Experience creating and maintaining healthy and creative relationships with study sites and principal investigators, helping to support and influence where required.
  • Excellent oral and written communication skills in English, including proficient presentation skills.
  • Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
  • Worked to ensure an enthusiastic and open attitude towards continuous professional development.
  • A proven, strong, clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward solutions which work first time.
  • Ability to self-motivate, be a team player, and work independently to manage competing priorities in a fast-paced environment required.
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated the ability to identify and resolve issues, and effectively manage timelines.

Desirable

  • Knowledge of and experience with immunotherapies in Oncology and/or Infectious Disease would be an advantage.
  • Ability to serve as a mentor, coach and trainer for assigned CRAs.
  • Ability to effectively support and manage exchanges with external customers; ability to speak and write in other languages a plus.
  • Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development).
  • Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.
  • Demonstrated effectiveness in resolving site management issues of varying complexity.
  • Strong communication, collaborative, and interpersonal/team skills.

Education & Qualifications:

  • BA/BS Degree required; degrees in health sciences strongly preferred.
  • A minimum of five (5) years of monitoring/site management experience is required, or equivalent combination of education, training, and experience.
    • Experience must include early phase clinical studies/Phase I-III studies.
    • Experience with global/international studies is highly desired.
    • Experience in oncology and/or infectious disease is highly desired.
  • Prior project team leadership experience preferred.
  • Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment required.
  • Working knowledge of budget management preferred.
  • Experience in managing people and/or contracted resources.
  • Must be able to travel domestically and internationally.
  • Located in close proximity to a major airport.
  • Proficient in Microsoft Word, Excel and PowerPoint and use of a laptop computer. Knowledge of MS project preferred.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.   

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

 

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