Provide Study Start-Up Specialist activities in support of assigned projects including IRB/IEC submissions, informed consent review, essential document collection and review in preparation of site initiation and activation. Provide leadership to junior department and project team members.
DUTIES AND RESPONSIBILITIES:
- Work closely with project teams to ensure efficient start-up processes for assigned projects in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor- specific requirements.
- May act as Study Start-Up Specialist Lead at project level; may directly interact with customers and sponsors as required. May serve as main point of contact for all project-specific Study Start-Up Specialist activities.
- Forecast site-specific submission/approval timelines based on site specific information and in accordance with Sponsor expectations and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact. Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently. Communicate regularly with study team members and escalate complex issues as soon as identified.
- Draft and/or review essential documents and templates for mass distribution to sites, distribute with initial welcome packets and arrange for receipt of essential documents; assist with dissemination of patient recruitment and other study materials and updates to essential documents.
- Collect, review for completeness and compliance, and track essential documents for Study Start- Up Specialist to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
- Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
- Participate in ICF development, review, negotiation and approval processes.
- Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
- Attend project team meetings and training sessions according to project and/or Sponsor requirements.
- Monitor number of hours/tasks available for Study Start-Up Specialist activities per project specifications; escalated discrepancies in a timely manner.
- May serve as main point of contact for Central IRB/IECs and prepare submissions for multicenter trials; facilitate preparation of site submissions to Local IRB/IEC as defined by local requirements. Facilitate and process IRB/IEC Continuing Review or Re-Approvals, Protocol Amendment and update to Investigator Brochure.
- Arrange for and/or review translation of essential documents as required.
- Assist with feasibility and site identification activities as needed.
- Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
- Assist with mentoring and training of department staff and new-hires.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience.
- Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required.
- Experience in Study Start-Up Specialist and activation and document collection and review required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent oral and written communication skills.
- Excellent interpersonal and organizational skills with strong attention to detail.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of clinical research.
- Good computer skills including MS Word, Excel, PowerPoint, Outlook.
- Experience with ICH/GCP documentation and process preferred.
- Ability to assess, coordinate, and organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines with focus on execution.
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.