FSP Sr CRA

Work Schedule

Environmental Conditions

Job Description

Summary of Essential Functions:

• Prepares reviews and coordinates local regulatory submissions (MoH EC additional special national local applications if applicable e.g. gene therapy approvals viral safety dossiers import license) in alignment with global submission strategy.
• Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develops and implements local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Serves as a key contact at the country level for ethical or reg submission-related activities
• Coordinates with internal department to align site start up activities with submission timelines.
• Support country specific Informed Consent Form (ICF) negotiations with EC/IRB or RA and raise any country-level ICF risks to ICM and study leadership. Develop site-specific ICFs manage ICF negotiations with EC/IRB and document site ICF approvals.
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as required in Submission Team Meetings Review Meetings and Project Team meetings.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPDs target cycle times for site activations.
• Prepares the regulatory compliance review packages as applicable.
• Liaise within Site managers locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develops country specific Patient Information Sheet/Informed Consent form documents.
• Identifies and recognizes local out of scope activities in a contract in a timely manner and advise relevant functions.
• Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversees country study files and ensures that that they meet PPD WPDs or client SOPs.
• Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
• Directs/mentors other SM individuals assigned to support projects of responsibility as appropriate
• Proactively identifies issues or anomalies in the regulatory process of a study resolves or escalates as appropriate.
• Align with site on critical SSU path upon selection accountable to maintaining tracking of site critical path
• ED collection and review submission of RCR packs review and submission of all EDC packs completion of Biogen SAF.
• Critical Path site activation plan and follow up.
• Ensuring site staff complete vendor trainings and receive vender system access (e.g. IRT system EDC raters).
• Ensures current investigator and site staff contact details are appropriately maintained in systems.
• Drafts executes and processes various company contracts reports and related documents with clinical study sites and principal investigators.
• Negotiates within approved parameters both investigator grant budget and contractual terms and conditions in accordance with client negotiation parameters established process with clients and follows established escalation routes.
• Coordinates stakeholder review of changes outside of negotiation parameters and submission of recommendation to resolve negotiations.
• Monitors and reports contractual progress to Site Contract Manager.
• Partners to reduce and/or eliminate company regulatory legal and financial exposure.
• Initiates and coordinates follow-up with stakeholders regarding the status of outstanding agreement issues in accordance with agreed process documents.
• Assists TMF specialist with eTMF QC and issue resolution in accordance with agreed process.
• Tracks common negotiation points for negotiation parameter updates in accordance with agreed process documents.
• Conducts site feasibility assessments to evaluate the suitability and capability of potential sites for clinical trials ensuring they meet the necessary requirements and standards.
• Performs site selection visits to assess the sites facilities staff qualifications patient population and overall capability to comply with the study protocol and regulatory requirements.
• Provides trial status tracking and updates. Ensures accuracy and completeness of study systems.
• Monitors investigator sites to ensure compliance and mitigate risks.
• Ensures data accuracy through various monitoring activities.
• Conducts and reports on monitoring visits in accordance with monitoring plan protocol ICH & Local regulations including confirmation and follow up letters.
• Conducts physical inventory and record reviews of investigational products.
• Documents observations in reports and letters using approved writing standards.
• Escalates deficiencies to management (including CSL or CML as applicable) and follows through to resolution.
• Responsible for initial and ongoing regulatory document amendments (e.g. ICFs) for assigned sites (per country feasibility based on scale)
• Attend meetings to discuss site statuses to include but not limited to: study start up progress trending and issue identification/escalation and general site updates.
• Submits documents to eTMF ensures eTMF is up to date
• Provide training and support to site staff on study protocols procedures and data collection methods.
• Maintains regular contact with investigative sites to confirm protocol adherence and resolve issues.
• Participate in internal audits and inspections ensuring that all study-related activities meet quality standards.
• Participates in investigator meetings and identifies potential investigators.
• Initiates clinical trial sites and ensures compliance with protocols and regulations.
• Ensures trial closeout and retrieval of trial materials.
• Ensures completeness of essential documents according to ICH-GCP and regulations.
• Conducts on-site file reviews.
• May contributes to project publications and shares ideas/suggestions with the team.
• Facilitates effective communication among sites client company and PPD project team.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Completes administrative tasks promptly.
• Contributes to project work and process improvement initiatives as required.

Education and Experience:

• Bachelors degree /previous experience comparable to 4 years as a clinical research monitor.

Other:

• Resources are global and location will be based on Protocol country and site distribution.