This person will be responsible for the conduct of multiple clinical research activities. Ideal candidate will have industry sponsored clinical trial experience and/or project management experience for investigator initiated projects. Person is able to work with minimal supervision and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits. Person will be responsible for leading and managing the project from the standpoint of clinical research activities. Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulations. Must adhere to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. Experience with clinical trials and industry sponsored studies preferred.
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Plan and coordinate strategies for patient enrollment, increasing patient enrollment, an improving efficiency.
- Review the progress of department research studies to ensure adherence to research protocols and take action to correct problems such as deviation from protocol requirements.
- Coordinate with other departments when necessary to ensure study-related procedures are performed according to the protocol.
- Coordinate and facilitates study-related meetings such as pre-study visits, site initiation visits, monitoring visits.
- Prepare for or participate in quality assurance audits conducted by internal staff, study sponsors, federal agencies, or specially designated review groups.
- Maintains own study participant caseload.
- Periodically reviews study participant research charts and assesses the quality of work for each CRA/CRA-RN.
- Coaches CRAs/ CRA-RNs in areas that need improvement.
- Periodically observe specimen collection, processing, shipping and storage activities to ensure they are conducted appropriately.
- Periodically observe the investigational drug ordering, deliver, administration, return and accountability activities to ensure they are carried out appropriately.
- Keep research management informed in a timely manner of actual or potential deficiencies in quality or performance of CRAs/ CRA-RNs.
- Assists research management in developing systems for assuring protocol adherence and data quality.
- Assist in the annual evaluations of research associates as applicable.
- Acts as an internal and external research leader at Holy Cross Hospital, advising staff regarding complex protocols and projects.
- Encourages teamwork and cohesion within the research work unit, and between research and other departments in the organization.
- Coordinate delegated activities during the contract and budgeting process.
- Oversee the training and development of new associates.
Experience & Skills:
- Bachelor's degree with a minimum of 4 years of experience in clinical research required, or Master's level degree with a minimum of 3 years of experience in clinical research required.
- Current certifications with ACRP (CCRC) or SOCRA (CCRP) as a clinical research coordinator required.
- Minimum two (2) years of clinical trial research experience preferred
- Needs to demonstrate consistent professional conduct and meticulous attention to detail
- Must possess excellent verbal and written communication skills and excellent interpersonal skills
- Ability to work independently
- Must be computer literate; proficiency in Microsoft Word and Excel a must.
- Able to effectively present information and respond to questions from physicians, staff and patients.
- Good organizational skills.
- Able to function effectively in a team setting
- Driving may be required on some occasions
- SOCRA/ACRP Certification preferred (required to sit for CCRP/CCRC after 2 years' experience)
Our Commitment to Diversity and Inclusion
- Current BLS Certification required
Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.
Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.
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