CLINICAL RESEARCH JOB DESCRIPTION

Clinical Research Assistant Details:

• Assist with recruitment efforts, screening potential study participants and scheduling study visits, as needed
• Gather and prepare study-related materials for participant visits
• Administer structured tests and questionnaires on cognitive function, depression symptoms, cardiovascular disease, stress and physical activity by telephone and at in-person visits for 500 randomized participants enrolled in the NOURISH trial
• Enter data into study case report forms and/or electronic data capture systems and respond to queries in a timely manner
• Collect and record anthropometric measurements of height and weight on post-stroke patients, as well as blood pressure readings. Demonstrate measurement reliability with structured tests, anthropometrics, and blood pressure readings
• Utilize study-related technology and equipment as part of data collection procedures
• Maintain accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant IRB approvals, source documentation, and study related communication as assigned
• Attend regular team meetings to discuss matters concerning participants, data collection, and problem solving
• Interact effectively with the Principal Investigator, Co-Principal Investigator, Program Manager, and all staff of the NOURISH trial
• Perform related duties as assigned. 

Clinical Research Assistant Qualifications and Requirements:

• High School Diploma
• Ability to meet deadlines
• Troubleshoots field issues when necessary. Uses discretion to resolve issues when unplanned events arise
• Detail oriented with a high attention to accuracy
• Ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants
• Effective verbal and written communication skills
• Ability to collaborate within multi-disciplinary team settings
• Availability to work evenings, overnight and weekends if called for under the study protocols
• Skilled in operating iPads and laptops
• Completion of a Bachelor's Degree or higher in a field related to health science
• Experience conducting structured interviews or other forms of data collection
• Outstanding communication skills and able to work with a diverse group of individuals in a professional manner
• Excellent organizational, interpersonal, problem-solving, and logic ability skills
• Must be able to focus on tedious mental tasks with great accuracy. There is a great amount of clerical and data entry work for this position that have deadlines and require a high level of accuracy
• Basic knowledge of email, Excel, Microsoft Office and Adobe

Clinical Research Associate Duties:

• Support project management and administration in clinical trials of medical devices and device related feasibility studies as well as in in government funded research projects and international investigator-initiated trials
• Develop, review, and edit clinical trial related documentation (study specific documents, handbooks, guidelines, checklists)
• Develop and create Investigators Site Files
• Provide support to the infield CRAs in the conduction of site selection, study initiation, interim monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) regulations and standard operating procedures (SOPs)
• Manage clinical trial documentation including the Trial Master File (TMF), perform periodic TMF reviews and follow up on outstanding items until resolution
• Set-up and maintain tools for tracking documentation, payments, and all clinical trial related activities
• Disseminate clinical trial related information including project tracking updates to the Clinical Project Manager (CPM), clinical trial teams and other departments
• Act as the central contact for the clinical trial team and trial sites for designated project communications, correspondence, and associated documentation
• Prepare and coordinate specified clinical trial meetings (Investigator Meetings, study team meetings) and create and distribute meeting agendas and minutes
• Support clinical trial teams in ethics and regulatory submissions: Collect essential documents and review essential documents for proper content, liaise with the CRAs and clinical trial sites to resolve outstanding issues
• Prepare devices for clinical trial participants and ensure proper supply at clinical trial sites
• Support vendor management
• Participate in feasibility and/or site identification activities

Clinical Research Associate Qualifications:

• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
• Minimum of 1 year of experience in Clinical Research, e.g., as a CTA, CRA or start-up specialist
• Good knowledge of ICH-GCP, basic monitoring procedures and basic understanding of the overall clinical trial process
• Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
• Prior experience in general remote site management activities and clinical trial administrative tasks plus understanding of the national laws and regulations governing medical device studies
• Fluid oral and written communication in German (at least C2 level) and English
• Excellent communication and interpersonal skills
• Advanced computer skills including proficiency in Microsoft Office applications
• Flexibility and ability to work independently to coordinate with the CPM all necessary activities required to set up, conduct and close-out a study
• Attention to detail and ability to prioritize tasks effectively
• Curiosity to work in the new and rapidly evolving field of digital therapeutics
• Based in Munich or within one hour of travel around Munich, ready and willing to spend at least two days per week in the office

Clinical Research Coordinator Roles:

• Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out.
• Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities.
• Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates.
• Responsible to deliver or exceed project enrollment targets for clinical research studies at their site.
• Responsible for accurate and timely data entry into the electronic data entry systems.
• Responsible for timely resolution of all data queries to meet project timelines for database lock.
• Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law.
• Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry.
• Understands and promotes compliance with all applicable healthcare and research regulations.

Clinical Research Coordinator Requirements:

• BS/BA preferred.
• Minimum 1 year of clinical research experience or equivalent experience.
• Reliable transportation to travel between local research sites.
• Commitment to and role model of DaVita’s values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions.
• Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through.
• Experience in managing confidential information and/or issues using discretion and Judgment
• Certified Clinical Research Coordinator (SOCRA or ACRP) – preferred

Associate, Clinical Research Manager Duties;

• Support the development of study protocol and ICF
• Assist Clinical Trial Manager (CTM) with the development, approval, and maintenance of all study plans (i.e. trial risk management plan, communication plan, monitoring plan, data cleaning plan, etc.).
• Assist CTM with the development of charters for DMC or CEC.
• Draft site feasibility questionnaires and maintain tracking report
• study startup (i.e. site selection, preparation of site binders and regulatory binders) and,
• study conduct (i.e. process study supplies, access to systems like EDC, IRT, Payment Vendor, etc.
• study closeout (track equipment returns)
• Coordinate with TMF Manager in ensuring the Trial Master File (TMF) is inspection ready.
• Support Audit and inspection related activities
• Provide status of trial deliverables to key stakeholders (i.e. Clinical Trial Manager and others.)
• Vendor Management
• Participate in vendor selection, RFI, RFP
• Review and approve invoice
• Prepare presentations and recruitment graphs required for reporting to key stakeholders
• Lead or support Study Team in Investigator Meeting planning and preparation (i.e., operational presentation oversight of meeting planning vendor, review of presentation, primary point of contact
• Assist in preparation and tracking of CRA training materials
• Assist in the preparation of SIV materials
• Contribute to the preparation of centralized monitoring plan
• Contribute to the development and management of study tools
• Contribute to the EDC and IRT development and UAT
• Contribute to the building and testing of electronic trending tools
• Review protocol deviations and perform root cause analysis when applicable
• Provide oversight of Data Quality Representative
• Support the selection, set up of labs through study conduct.
• Tracking of supply kits and samples through issue resolution
• Send out meeting invitation, prepare agenda and minutes, file approved minutes in TMF.
• Provide leadership to cross functional study team.

Associate, Clinical Research Manager Knowledge and Educations:

• BA or BS degree in Life Science preferred
• Minimum 5 years clinical trial experience in pharmaceutical, CRO, or healthcare industry preferred
• Knowledge of GCP/FDA/ICH regulations required
• Understanding of clinical research principles and process
• Proficient in Microsoft Office (MS Excel, Word and PowerPoint, Project).
• Robust organizational and time-management skills.
• Strong interpersonal skills.
• Effective verbal and written communication skills including presentation skills
• Strong organizational skills are required, as well as the ability to balance changing priorities
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• A team player and ability to take initiative and lead

Clinical Research Manager Roles:

• Clinical research and documentation: Demonstrate good understanding of clinical research aspects. Employ evidence-based practice guidelines using research skills with clinical expertise in creating clinical content (assessments).
• Review: Verify accuracy of research data and monitor data quality control by periodic review of work done by the team. Review assessments- OOB, Client; functional specs for HEDIS/ Clinical condition rules/ HCC risk adjustment. Final review of Assessments/ Health Articles/ Health Indicators.
• Resource planning and coordinating with other teams for resources/tasks
• Serves as a mentor to staff, assisting them in professional self-developmental activities
• Provide general direction on accomplishing a task
• Clinical SME for Assessments/ HEDIS/ Clinical condition rules/CDPS, HCC risk adjustment/ Health Articles/ Health Indicators etc. Involve in issue identification and resolution
• Point of contact for clinical catalogs
• Involve in discussion of development of new modules like MTM etc. and explain requirements to BA
• Coordinate with the marketing team for compiling technical articles, reviewing and fine tuning it
• Lead efforts for development of new concepts on the application. e.g., clinical compliance
• Train employees when required
• Track and log work on JIRA
• Process improvement
• Other work-related duties as assigned

Clinical Research Manager Experience and Knowledge:

• MSN (master’s in nursing)/ M. Pharm / M.Sc. (Life Sciences) with 12 plus years’ experience in the field or related area
• Demonstrates good understanding of clinical research/healthcare aspects. Can interpret and analyze functional specifications for quality measures such as HEDIS and PQA
• Working knowledge of SQL desirable, not necessary
• Proficient in Microsoft Excel
• Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, PowerPoint)
• Prior data analysis experience is desirable, not mandatory. Proficient in excel skills with ability to analyze data in excel
• Ability to analyze facts and demonstrates good judgement
• Proven ability to handle multiple tasks in a deadline-oriented production environment
• Excellent written/ oral communication, interpersonal and presentation skills. Excellent organizational and time management skills

Clinical Research Nurse Functions:

• Conduct overnight clinical study visits in accordance with protocol.
• Overnight shifts are one/week (7PM-7AM).
• Refer patients to other healthcare resources when necessary.
• Educate study subjects about study protocol.
• Conduct clinical study visits in accordance with protocol.
• Monitor the subject prior to, during and after study drug administration according to the protocol.
• Elicit and assess adverse experiences and communicate these to the Investigator.
• Evaluate subject laboratory and physical findings with Investigator/sub-investigators; provide or obtain further information from subjects or healthcare providers as required in order to assist in diagnosis and treatment.
• Applies logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Interprets information from caregivers, nurses, or physicians about patient condition, treatment plans, or appropriate activities.
• Performs other related work as needed.

Clinical Research Nurse Abilities, Knowledge and Qualifications:

• Fundamental working knowledge of clinical research.
• Knowledge of patient care fundamentals, including aseptic principles and techniques.
• Ability to provide direct patient care in a professional and respectful manner.
• Excellent verbal and written communication.
• Ability to read documents or instruments.
• Ability to perform multiple concurrent tasks with occasional interruptions.
• Ability to exercise discretion and confidentiality while handling sensitive situations.
• Ability to solve problems by applying math or reasoning principles.
• Ability to adapt to changing working situations and work assignments.

Clinical Research Physician Roles:

• Assists senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISSs, ISEs, and clinical expert reports
• Develops and gives oral presentations, as required
• Ensures adherence to GCP/ICH and Client SOP standards
• Establishes and maintains working relationship with Study investigators, key opinion leaders, academicians, and Client Senior managers and department heads across the corporation
• Maintains clinical and scientific awareness in area of expertise
• Oversees and is responsible for the quality, coordination and timeliness of protocol development
• Oversees and is responsible for the quality, coordination, medical accuracy and timeliness of clinical study reports
• Participates in the organization, coordination and execution, as required, of internal Client meetings and external medical/scientific meetings, e.g., Investigator Meetings and clinical/scientific advisory board meetings
• Participates, as required, as a clinical representative on Project Teams
• Prepares clinical study timelines and status reports, as required, per Supervisor.
• Provides leadership to the clinical study team involved in the execution of clinical studies
• Supports clinical operations in site selection, study budget preparation, study execution and addresses clinical/medical issues at study sites
• Supports data management as required for CRF development, database edit checks development, listings review, query resolution, database clean-up and lock activities

Clinical Research Physician Skills, Knowledge and Experience:

• An advanced degree in a relevant field (MD, Ph.D., Pharm.D or equivalent advanced degree, with experience in clinical research and development
• 2-5 years clinical drug development process experience preferred
• Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Research and Development
• Excellent managerial and leadership skills or clear potential to develop such skills
• Excellent verbal communication skills to effectively represent Client at a corporate level, with internal working groups/project teams and external academic/industrial/regulatory organizations
• Excellent technical writing written skills
• Team player, possesses sense of urgency, is mentorable and exhibits potential for mentoring others.
• Must have planning skills to schedule activities to meet Clinical Research and Development and project team deadlines
• The position requires problem solving ability, and skills to address medical, clinical study and technical questions in a multi-disciplinary environment
• Must be technically proficient with standard PC software (Word, Excel, PowerPoint, Desktop products like Outlook)
• Must keep abreast of medical and scientific literature within the relevant therapeutic area that the individual is working in
• Must maintain high ethical standards and integrity at all times.

Clinical Research Scientist Responsibilities:

• Actively contribute to ensure the relevance of early stage research and increase its application
• Build working groups with relevant internal expertise and competencies
• Develop mid-to-long term clinical strategic plan for at least two brand categories
• Design the scientific content of study protocols of moderate-to-high complexity and other key study documents in collaboration with statistician
• Create scientific presentation materials and provide protocol, medical and safety training at study investigator meeting and site initiation visit
• Perform clinical data review, interpretation and topline data rollout to R&D and broader multidisciplinary teams
• Develop publication strategic plan for the responsible brand categories
• Ensure best practice in executing and delivering clinical trials on time, on budget, and with high quality results

Clinical Research Scientist Knowledge and Qualifications:

• MD or master’s degree and PhD with 4-6 years of postdoctoral and/or academic / industry job-related experience in study design, protocol development, research methodology, clinical data interpretation and publication is required
• Specialty training or extensive experience in human nutrition science and clinical development in the field of pediatrics, gastroenterology (GI function), gut microbiota, and immune health outcomes is highly desirable
• Proven ability providing in-depth scientific input in the development of clinical research portfolio strategy
• Aptitude to interpret and synthesize clinical data / statistical results in study reports, writing scientific abstracts and manuscripts, and presenting study results to internal R&D & business teams, and to external scientific community
• Proven ability to work in matrix organization and successful work experience representing clinical research on cross-functional category and project teams
• Knowledge in designing and delivering clinical studies leading to compelling claims/messaging
• Experience planning, executing, and managing global clinical trials.
• Skills in project prioritization, business alignment, and task allocation
• Demonstrated strategic thinking and solution finding in projects and/or complex studies

Clinical Research Specialist, Structural Heart and Aortic Details:

• Oversees, designs, plans and develops clinical evaluation research studies.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), Good Clinical Practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• May be responsible for clinical supply operations, site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
• Participates in overall clinical management plan, protocol and case report form development.
• Assists with site initiation activities, resolution and follow-up of site issues, and study closure activities.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
• Performs data review, reviews data discrepancies, generates reports.
• May interface with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs.
• Assists clinical management with other duties as requested.

Clinical Research Specialist, Structural Heart and Aortic Experience and Knowledge:

• Bachelor's degree and a minimum of 2 years of clinical research experience or advanced degree with 0 years of experience
• Degree in engineering, life sciences, or related medical/scientific field.
• CCRA certification (Certified Clinical Research Association), SOCRA.
• Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
• Experience in managing clinical trial data review.
• Experience in managing multiple clinical research sites with proven results in study execution.
• Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting.
• Experience with Clinical Operations and interfacing with CRO teams.
• Clinical study management experience
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
• Excellent project management and organization skills.

Field Clinical Research Specialist Roles:

• Providing field support for various clinical research studies by selecting sites, performing activation duties, setting up protocols, providing training, helping to enroll participants and supporting cases.
• Utilising clinical research in site needs.
• Gaining and maintaining knowledge of clinical sites in a given geographic area.
• Providing continuous communication to in-house clinical trial leaders regarding the status and performance of multiple studies.
• Assisting with overall successful conduct of assigned clinical studies.
• Identify and mitigate quality risks and issues for assigned clinical studies.
• Assisting in control of device allocation, distribution and reconciliation.

Field Clinical Research Specialist Experience and Requirements:

• Bachelor’s degree with minimum of 4 years of experience in clinical research/clinical (e.g., field clinical research/clinical specialist/field clinical engineer) or advanced degree with a minimum of 2 years of experience in clinical research/clinical (e.g., field clinical research/clinical specialist/field clinical engineer).
• Proficiency in French, German, and English.
• Good Clinical Practice and regulatory compliance guidelines for clinical trials.
• Medtronic or within the medical device industry.
• Management of clinical devices.
• Cardiovascular/cardiac rhythm management device training (e.g., pacemakers and defibrillators).
• Certification from a Clinical Research Association.

Clinical Researcher Duties:

• Lead the company's pre-clinical strategic & operational efforts.
• Work closely with the management team to align pre-clinical objectives.
• Develop pre-clinical strategies, study protocols and GLP compliant reporting.
• Act as the key partner to our pre-clinical research facilities.
• Prepare and take part in management meetings.
• Conduct strategic research, prepare presentations and reports.
• Represent STENTiT at conferences and KOL meetings.

Clinical Researcher Requirements:

• Master/PhD degree from relevant field (e.g. biology, biomedical engineering, regenerative medicine, life sciences).
• Competency requirements art. 9 or 13f.2 (WOD)
• Proven track record and own experience in planning, executing and documenting pre-clinical studies.
• Excellent analytical, statistical and quantitative skills.
• Ability and willingness to thrive in a fast-paced entrepreneurial environment handling multiple workstreams independently at any given time.
• Willingness to travel to third party locations within Europe.
• High motivation to work on dynamic topics as well as get done whatever is necessary.
• Excellent communication skills in Dutch and English.