FSP Sr CRA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 PPD’s 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 WPD’s or client SOP’s.
• 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 site's 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:

• Bachelor's 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.