8 Clinical Development Director jobs in Eastlake

We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more in our careers and in our communities.

Job Description Summary: The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies.

Responsibilities And Duties: Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required.

Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant.

Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location.

Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports.

Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation.

Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned.

Minimum Qualifications: Bachelor's Degree (Required) Additional Job Description: Degree required from a four-year college or university.

SPECIALIZED KNOWLEDGE Ability to prioritize assigned work.

Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks.

Strong computer skills, including thorough knowledge of systems (EMR, Microsoft)

DESIRED ATTRIBUTES One year of relevant work or academic experience preferred.

Prior experience in a medical environment preferred.

Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification)

One or more years of direct human subjects research

Clinical knowledge in assigned therapeutic area or program

MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS: Study Planning and Coordination Assists with implementation and coordination of research studies and projects.

Accountable to PI for study specific responsibilities.

Works closely with PI and direct supervisor to organize, plan and carryout the research in an efficient and timely manner.

Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations.

Assists with recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI.

Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant's visits and assessments.

Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period.

Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives.

Participate in in-house protocol meetings to review study-related procedures, staffing and visit flow.

Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study.

Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events.

Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation.

After closeout visits have been conducted, prepares study documents for archiving according to timelines.

Responsible for in-depth knowledge of protocol requirements and GCP guidelines.

Performs other related duties as assigned or required.

Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants.

Assists nursing and clinical staff and utilizes knowledge of disease processes to observe and report adverse events and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant.

Quality and Compliance Assists in audit preparedness activities for OHRI.

Assists with monitoring visits on site and is available during visits for corrections, questions, etc.

Maintains study records according to sponsor and/or regulations.

Keep records in a secure location.

Reporting Assist in the development of reporting metrics.

Generates reports and reviews to ensure validity of data.

Provide ad hoc reports.

Communication Demonstrates effective communications skills.

Communicates information in a timely and accurate manner.

Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies.

Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers.

Uses various media forms to maximize communication success.

Demonstrates teamwork characteristics.

Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects.

Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level.

Work with research staff to effectively communicate patient process for each trial for the life of the study.

Advise, communicate and reinforce standard practices, regulations to following regarding research study participation.

Other Attends relevant training courses on policy and compliance.

Ensures assigned training is complete and meets internal qualifications.

Responsible for completing all necessary training for their position

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.
• Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
• Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person pre screens.
• Create and execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand product development life cycle and significance of protocol design including critical data points
• Understand the disease process or condition under study
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone's work on an ongoing basis and in preparation for monitor visits.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope
• Other duties as assigned

• Bachelor's degree and 2 years relevant experience in the life science industry OR
• Associate's degree with 4 years relevant experience in the life science industry OR
• High School Graduate and/or technical degree with minimum of 6 years relevant experience in the
  life science industry AND1 year Clinical Research Coordinator experience

• Demonstrated knowledge of medical terminology
• Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Proficient ability to work in a fast-paced environment
• Proficient verbal, written, and organizational skills
• Proficient interpersonal and communication skills
• Proficient ability to work as a team player
• Proficient ability to read, write, and speak English
• Proficient ability to multi-task
• Proficient ability to follow written guidelines
• Proficient ability to work independently, plan and prioritize with minimal guidance
• Proficient ability to be flexible/adapt as daily schedule may change rapidly
• Must be detail oriented
• Demonstrated problem solving and strategic decision making ability.
• Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
• Demonstrated leadership ability

• Sit or stand for long periods of time
  Travel locally and nationally
• Communicate in person and by a telephone
• Limited walking required
  Limited to lifting up to 30 pounds

Provides safe efficient age specific nursing care to patients/families using the nursing process in order to assist them to attain, maintain, regain, and sustain optimal health status.

What You Will Do

• Implements the nursing process by delivering effective relationship based nursing care.
• Demonstrates technical skills in care delivery that result in safe practice and positive care outcomes.
• Demonstrates clear communication and effective collaboration to optimize patient care and clinical operations.
• Develops self and contributes to the professional practice of nursing.
• Displays leadership that influences optimal clinical and operational outcomes.

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.