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Sr. CRA

Cary, NC 27513

Posted: 08/07/2023 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 577408 Is job remote?: Yes Country: United States

Job Description


Senior Clinical Research Associate

Summary:

To ensure that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH). May be responsible for assisting the RA Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications.

This is a full-time, direct hire opportunity for an experienced CRA/SCRA residing in the US. Ideal candidates should have a variety of trial monitoring (field & remote) and full site management experience working with Oncology and/or Cell and Gene Therapy (CGT) trials. This position requires flexibility with travel, on average, 70-80% range.

Location: US (remote)

Travel: 70-80% range throughout the US (depending on studies)

Preferred TA experience: Oncology

Your Role:
  • Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
  • Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
  • Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
  • Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
  • Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Collect and review regulatory documents as required.
  • Prepare site visit and telephone reports.
  • Responsible for multiple projects and must work both independently and in a team environment.
  • May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
  • Resolve site issues and determine status for IP shipment.
  • Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
  • May translate, coordinate translations or review completed translations of critical documents.
  • Participate in feasibility and/or site identification activities.
  • Assist the Project Team with the day-to-day management of clinical studies as required.
  • Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
  • Train, mentor and/or supervise junior staff.
  • May be assigned as LCRA to a regional or global study.
  • May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
  • Conducts project co-monitoring, assessment visits and team training.
  • Site contact for protocol clarifications and subject enrolment if CRA unavailable.
  • Participate in the development of study newsletters communication as required.
  • Assist with the development of project-specific training materials for team.
  • Liaise with Business Development and make presentations to potential clients as required.
  • May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
  • Other responsibilities as required.
Requirements
  • Based in the United States of America (any region)
  • At least four years clinical monitoring experience and/or relevant clinical trial experience.
  • Relevant life science degree / medical / nursing background, or combination of education and experience.
  • Skills to mentor and train other CRAs in a positive and effective manner.
  • In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
  • Strong oncology therapeutic background
  • Can demonstrate experience and knowledge in the CRO industry that will support POI’s management of clinical trials.
  • Has shown ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
  • Demonstrates the ability to define and meet project requirements.
  • Can demonstrate flexibility for improvement and creating solutions.
  • Proven organizational abilities, and excellent written and oral communication and presentation skills.
  • Excellent team player with team building skills.
  • Strong customer focus.
  • A thorough knowledge of regulatory submission and reporting requirements and guidelines.
  • Excellent understanding of the drug development process.
* target 125k range

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cary, NC

Ready to elevate your career? Explore exciting job opportunities in the vibrant area surrounding Cary, North Carolina. Known for its unique blend of southern charm and thriving economy, Cary offers an ideal environment for professional growth and work-life balance. From the serene beauty of William B. Umstead State Park to the cultural richness of the North Carolina Museum of Art, there is no shortage of attractions to explore. Indulge in the region's renowned BBQ joints, catch a performance at the Duke Energy Center for the Performing Arts, or cheer on the Carolina Hurricanes at PNC Arena. Join us in Cary, NC, and discover why this dynamic community is the perfect place to advance your career.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.