A highly reputable pharmaceutical organization is currently looking for a Clinical Trial Associate to work in Philadelphia, PA.
- Clinical Trial Associate role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure alignment with study timelines.
- Acts as the focus for the project team administration and provides the Clinical Trial Manager and all other project team members with assistance and support, as required, thus ensuring that the clinical trial is conducted in accordance with international regulatory and ethical guidelines for Good Clinical Practice and Standard Operating Procedures.
- Assists CRAs, Lead CRAs (LCRA), Clinical Operations Leaders (COL) and Clinical Trial Managers (CTM) with the day-to-day administrations of clinical studies.
- Tracks critical documents and informs CTM / COL and/or LCRA of outstanding documents.
- Accurately updates and maintains clinical systems within project timelines.
- Prepares, distributes, files, and archives clinical documentation Reviews study files periodically for accuracy and completeness
- Prepares and distributes clinical trial supplies and maintenance of tracking information.
- Assists CTM / COL / LCRA / CRAs with collection and filing of critical documents and documentation required for submission to Regulatory Authorities and Ethical Committees.
- May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- Performs administrative tasks to support team members with clinical trial execution, as required.Provides training and mentoring, as required, on procedures and clinical trial administration. Resolves logistical and practical issues.
- Prepares Trial Master File according to SOPs.
- Reviews study related Trial Master File documentation to ensure compliance with SOPs and ICH-GCP on an ongoing basis, and before audit, inspection, or return of files to a Sponsor.
- Follows up study team or Sponsor requests for clarifications, supplementary information.
- Assists CTM with generation of study specific forms for Investigator Site Files.
- Attends Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting.
- Attends clinical teleconferences and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines.
- Prepares Investigator Site Files, Investigator Manuals and Training Manuals.
- Manages returning/archiving study files.
- Generates and reviews management reports from internal tracking systems at requested intervals.
- Communicates with sites regarding trial start-up, conduct, and close-out activities at requested intervals, if needed.
- May participate in feasibility and/or site identification activities.
- Assists in resolution of logistical and practical issues on project and clinical trial administration processes.
- Experience of at least 2 years within a similar role or as a clinical research coordinator
- Customer service orientation
- Sound knowledge of medical terminology and clinical monitoring process
- Strong verbal and written communication skills
- Computer literacy, proficiency in Microsoft Office
- Excellent interpersonal and organizational skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Attention to detail
- Good presentation skills
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and vendors
- Minimum of bachelor’s degree with strong emphasis on science required
- 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.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.