Skip Navigation

Senior Field Clinical Research Associate (FSP)

Poland - Any Region - Home Based Date posted 01/17/2022 Job ID 78019BR

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.

As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent
  • "The last 4.5 years I had a steep learning curve and I am still learning via on-the-job challenges and solid management feedback. Next to my personal growth, I also enjoy our open atmosphere and the great collegiality."

    Stefanie – Sr Clinical Research Associate

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

The Senior Clinical Research Associate (SCRA) is responsible for field monitoring and management of clinical sites.
This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with ICH/GCP Guidelines. This role may provide operational input to clinical study teams as directed.

Organizational Relationships:
  • Reports to FSP assigned Line Manager with day-to-day direction from the Client.
  • Liaises with cross functional lines as appropriate.

Primary Duties:
  • Act as liaison between the in-house team, vendors, and multiple clinical sites.
  • Work collaboratively with investigative sites to develop strong, long-term, working relationships.
  • Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
  • Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
  • Assist with start-up activities, including essential document review and collection as requested.
  • Perform Site Initiation Visits.
  • Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
  • Perform Interim Monitoring Visits for assigned studies
  • Perform Close Out visits as assigned.
  • Prepare and submit visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
  • Maintain Clinical Trial Management (CTMS) in a timely fashion, utilizing available reports and study tools.
  • Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to Client/site per CMP.
  • Provide co-monitoring support as requested.
  • Contribute to the preparation and follow-up of on-site Seattle Genetics sponsored quality audits and regulatory authority inspections as assigned.
  • Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides).
  • May have opportunities to contribute to other clinical trial related activities, including vendor management, data review, or other study-related activities.
  • Contribute to department initiatives.
  • May contribute to development and revision of study specific Clinical Monitoring Plans and CRF Completion Guidelines and other study documents.

Qualifications

  • Oncology TA area experience.
  • BA/BS, or equivalent, or relevant experience and training with at least 4 years independent CRA Experience - all types of visits.
  • Flexibility towards work assignments, learning, and travel.
  • Able and willing to travel approximately 55-75%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.
#INFSP

Join our Talent Community

Welcome to the Parexel Talent Community! Sign up below and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.

Recently Viewed Jobs

You have not recently viewed any jobs

View all jobs

RECRUITMENT FRAUD ALERT

It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify Jobs@Parexel.com. You may also report suspicious fraudulent activity to your local law enforcement agency or the FBI. Thank you.