Job Description
Overview
Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The
Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned.
Responsibilities A day in the life of a
Clinical Research Coordinator at Hackensack Meridian Health includes:
- Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
- In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
- Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator. 4. Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required.
- Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary.
- Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.
- Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
- Registers protocol patients with appropriate statistical centers as required.
- Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Acts as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel.
- Along with clinical research nurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
- Works closely with clinical research finance to ensure study patient's clinical trial related activities are billed appropriately.
- Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.
- Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens.
- Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
- Organizes space for study equipment and supplies.
- Participates in the development of study protocols including guidelines for administration or data collection procedures.
- Contacts outside health care providers and communicate with subjects to obtain follow-up information.
- Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Attends research meetings and conferences as required.
- Participates in staff meetings and in-service education as necessary.
- Other duties and/or projects as assigned.
- Adheres to HMH Organizational competencies and standards of behavior.
Qualifications Education, Knowledge, Skills and Abilities Required:
- BA/BS diploma/degree in science or healthcare field.
- Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
- Strong attention to detail and customer service focus.
- Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
- Excellent organizational, presentation, documentation and interpersonal skills.
- Excellent written and verbal communication skills.
- Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
Education, Knowledge, Skills and Abilities Preferred:
- Education on human subject research and GCP.
Licenses and Certifications Preferred:
- SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
Starting Minimum Rate Minimum rate of $78,395.20 Annually
Job Posting Disclosure HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to:
Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness.
Experience: Years of relevant work experience.
Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training.
Skills: Demonstrated proficiency in relevant skills and competencies.
Geographic Location: Cost of living and market rates for the specific location.
Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization.
Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered.
Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.
In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
Job Tags
Hourly pay, Full time, Part time, Apprenticeship, Work experience placement, Work at office, Local area, Shift work, Night shift, Weekend work, Afternoon shift,