Anticipates and identifies issues that could affect the quality of data, systems or processes and develops alternative solutions, or ensures corrective action is implemented as appropriate. If applicable, assists with Investigator Site and Vendor Payments according to local Finance processes and relevant systems. The key impact of this role is to ensure, through their contribution to the local Clinical team, that Site Management & Monitoring fulfills its commitment to the global organization. Active study team member through trial life cycle for assigned studies; may act as a SME contact and /or lead CPA for a particular TA, Program, or process. Serve as mentor for less experienced or junior team members. Key Responsibilities Include:
- The Sr. Clinical Project Assistant (SCPA) provides administrative and clinical management support to Site M& M personnel and assist them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management & Monitoring personnel assigned to clinical studies conducted within the country
- Creates a local trial file for the filing of Country specific original documentation. Supports Site M& M personnel with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents. Supports Site M&M personnel with translation of Clinical Study documents and local Clinical Team with preparations for PSVs, SIVs, and COVs, as necessary. Ability to triage tasks and provide mentoring to junior team members.
- Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensures the Investigator Site Files are created, contain the correct and complete documentation, and are sent as appropriate to the Investigational Sites. Internal/ External Contacts and Interactions: Uses multiple technologies to maintain open and frequent communication with Site Management & Monitoring personnel. Maintains a positive working relationship with internal/external customers.
- May need to contemporaneously update systems/databases (i.e. CTMS, eTMF system) with Country or Site related data, if applicable. Forwards safety information to the appropriate group. In-house support for CRAs during site visits (point of contact etc.) Ability to run system reports to ensure accuracy and completeness, and tracking/reporting to study teams. Ability to triage tasks and provide mentoring to junior team members.
- Acts as in-house support for CRA's with the handling and destruction arrangements of Investigational Product as, and if, required. This may include the entering of relevant information into Interactive Web-based Reporting Systems. Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs). Ability to triage tasks and provide mentoring to junior team members.
- Participates in pre-audit activities to meet both PV and GCP Audit requirements. Supports SMM personnel to ensure audit and inspection readiness in clinical activities. Ensures financial information for studies/sites is entered into systems in compliance with company policies. May participate in global Task Forces and Initiatives. May act as a SME contact in pre-audit activities. Provides support for audits/inspections. Ability to triage tasks and provide mentoring to junior team members.
- Supports Clinical Team with the processing of Expense Reports and Travel arrangements. If assigned, supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.). If appropriate, assists with the filing of training records and other relevant personnel documentation for staff. Ability to triage tasks and provide mentoring to junior team members. Delete
- Supports Line Managers with onboarding process of new staff. Supports Affiliate Clinical Team with local SOP's and Work Instructions updates. May support or be responsible for the update and maintenance of the training files of the SMM team within the affiliate. Acts as a local liaison for CRO studies, if applicable. Proactively identify areas of improvement and suggest solutions to mitigate deficiencies/enhance processes.
- May interface with and build collaborative relationships with: Local personnel including Medical Dept and within Clinical Operations (e.g., SMM personnel in other Countries and Doc Management), external service providers, study personnel (e.g., investigators, study coordinators, pharmacists, etc.), peers within the organization, and vendors, as well as Safety Representatives, Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas.
- Sr. CPA will conduct and manage start-up and maintenance activities of investigative sites. Provide leadership/training/mentoring activities for new and current staff and collaborate with the Primary site monitor and US Outsourcing team for site activation. Build and review ICFs. Ability to triage tasks and provide mentoring to junior team members.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic .
- Appropriate life-science or health-care related qualification or equivalent work experience. Minimum of 3 years experience in a clinical research setting or professional equivalent work experience.
- Proven track record of success and strong knowledge related to ICH/GCP Guidelines and applicable local regulations and local regulatory process experience.
- Proficient in application of the conduct of clinical trials and its associated activities and responsibilities. Ability to Operate independently and lead and mentor as SME.
- Previous administrative experience is desired. Ability to manage multiple projects and prioritize appropriately. Ability to develop, lead and conduct training activities for new and current staff. Serve as mentor as needed.
- Possess Strong Oral and Written Communication Skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy.
- Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with multiple high priority competing projects and deadlines.
- Ability to manage multiple priorities/projects, communication and interpersonal skills, including situations of conflict resolution, problem solving, crisis management, and change management. Proactive and positive team player.
- Written and verbal fluency in English and local language (if not English). Proficient knowledge of all standard IT office tools.
- Proven ability to communicate effectively within a multi-cultural/global team environment.
- Exhibits high level of flexibility and leadership when facing changes in the work environment.
Associated topics: aseptic technique, cytometry, dietician, food scientist, injury, metabolism, nutrition, patient, physiology, vaccine