Clinical Trial Specialist
Chadds Ford, PA
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Specialist. This is a remote position, can be based anywhere, preferably East/Mid-west locations. This position is responsible for working with internal and external partners on all aspects involved with the planning, implementation and management of a clinical research trial(s). The Clinical Trial Specialist ensures that the most effective and efficient processes are in place to meet the timelines and deliverables commensurate with the planning, start-up, recruitment and close-out of the trial. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Organize and maintain study files and regulatory documents and provide tracking support for trial-related activities including Trial Master Files (TMF)
- Responsible for coordinating the day to day work flow of collection and review of required document for study start. The duties include set-up, maintenance and distribution of required documents
- Works with internal Clinical Trial Managers to coordinate activities (e.g., documents, study supplies, distribution of system credentials etc.) leading to SIV
- Assists with conducting feasibility as applicable and/or support the documentation of decision related to final country/site selection
- Enter and maintain data into designated study tracking systems
- Assist the trial(s) team with communication/contact with investigative sites/external vendors
- Assist in updating trial(s) status overviews, preparation of presentations, tracking of drug supply tracking
- Help to ensure audit readiness of clinical trials across all compounds
- Work closely with site to assist in center initiation and study start up activities
- Documents site and sponsor communications as applicable
- Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements
- In conjunction with Study Manager, coordination and review of documents requiring translation (e.g., diaries, emergency cards etc.)
- Customize country/site specific ICFs /patient information sheets
- Provides status updates to project and cross-functional teams as required
- Collaborate and assist the development operations team and members of the multidisciplinary team on all operational aspects of the clinical study as assigned
- Strong organizational and time management skills
- Excellent attention to detail
- Ability to work independently
- Willingness to complete routine administrative tasks while gaining exposure to regulations pertaining to clinical research
- Experience with MS Office programs
- Excellent written and verbal communication skills
- Experience working as part of a multi-disciplinary team is desired
- Research or healthcare-related experience is required
- BS/BA degree ore relevant degree
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.