Clinical Support Specialist Ii

Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

The Clinical Support Specialist II (CSS) provides administrative and operational support to project teams throughout the project life cycle; may move into increased responsibilities as knowledge base and skills expand. Oversight of CSS tasks to be provided by the Principal CSS, CTM, or delegated by the PM, as appropriate

**Essential functions of the job include but are not limited to**:

- Serves as a member of the Project Team and provides administrative and operational support with the goal to contribute towards efficient management of studies.
- May fulfill the role of Lead CSS, as applicable.
- Assists in the set-up maintenance, and final reconciliation of the Trial Master Files according to the project plan.
- May assist in the development and revision of applicable CSS tasks related study plans such as Site Activation Plan, TMF Plan, Translation Plan, etc.
- Maintains quality control of the documents/files as per study milestones outlined in the project plan.
- Collaborates with the project team and other internal functions to ensure that the TMF is audit/inspection ready.
- Assists in planning, organizing, and executing project-specific meetings including but not limited to client meetings, CRA training, Investigator Meeting and PI meetings.
- Assists set up and activities for study tracking for internal and/or external purposes (e.g., Study Team Training, Start-up Activity, TMF QC, etc.), as applicable.
- Assists with study start-up of clinical studies under the direction of a more senior CSS or the CTM, may assist sites through the start-up process for feasibility and investigator recruitment, essential document collection, IRB/Ethics submission and IP Activation, as applicable to local and regional standards.
- May conduct country or site level ICF review, as applicable to local and regional standards.
- May conduct the translation process of site level documents, as applicable.
- Point of contact for project-related requests for team members, Sponsors, and third-party vendors, as applicable.
- Responsible for review, tracking and filing of the essential documents for investigational sites as well as follows-up on missing/incomplete/invalid documents.
- Distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance.
- Coordinate the distribution and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
- May contribute to financial tasks for the study (e.g., investigator/institution/vendors payments), coordinating tracking, as applicable.
- May coordinate eTMF progress with partnering CROs, with SME guidance.
- May present applicable status updates during internal/external meetings (e.g., eTMF metrics, process reminders, etc.).
- May assist team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
- May support onboarding or mentoring activities of CSS team members.
- Performs other duties as assigned.

**Qualifications**:
Minimum Required:

- Graduate of a secondary education or equivalent degree required.
- Minimum of 1 to 3 years of clinical research experience.
- Minimum of 1-2 years of experience as a CSS.

Other Required:

- Must have established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint).
- Must possess a customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
- Ability to speak English proficiently (Professional level).
- Ability to travel domestically and internationally, including overnight stays.

Preferred:

- University degree

**Competencies**:

- Demonstrates a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.
- Demonstrates solid interpersonal skills.
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
- Supports the development and mentoring of CSS staff.
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders.
- Communicates both verbally and in written form in an efficient and professional manner.
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion,